Nicole Muschol, M.D. to Present Long-Term Data on Tralesinidase Alfa (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB) SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--May 28, 2026-- Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and
Phase 3 ACHIEVE results showed Foundayo, an oral GLP-1 taken without food or water restrictions, outperformed oral semaglutide and dapagliflozin in type 2 diabetes, reinforcing its potential to redefine oral incretin therapy New analyses of the ATTAIN program highlight Foundayo' s profile in
“Best of EASL” oral presentation highlights meaningful reductions in triglycerides, cholesterol, and blood pressure, along with improvements in key metabolic risk factors PERFORMA Phase 3 trial to further evaluate the broad metabolic and liver-related effects of pemvidutide GAITHERSBURG, Md., May
Crofelemer delayed-release tablets are Jaguar's FDA-approved prescription drug under botanical guidance ("botanical drug") derived from the Croton lechleri tree. Crofelemer, in a novel liquid formulation, is being developed as the potential first oral adjunctive therapy for Intestinal Failure (IF)
First patient dosed marks rapid transition from trial activation to active treatment in patients with acute lung injury from all cause pneumonia meeting Global ARDS criteria Landmark advances a first-in-class immune therapy for critical illness where there are no approved mortality-reducing
TEL AVIV, May 28, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that multiple abstracts across its oral peptide pipeline have been accepted for presentation at ENDO 2026, the annual meeting of the
NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026 Bezuclastinib combination is first treatment ever to demonstrate statistically significant
Pivotal B-Well data show a significant 19% functional cure in the overall study population and 26% in patients with lower viral activity.
- BLA submission based on positive results from Phase 3 INDIGO trial - WALTHAM, Mass., May 28, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the
NEW HAVEN, Conn., May 28, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced the presentation of new positive data from the Phase 3 SERENITY
– Late-Breaking Poster Introduces New Unified Statistical Analyses for Assessing Confirmed Disability Changes for Trials in Progressive Multiple Sclerosis – – Additional CALLIPER Data Further Highlight Vidofludimus Calcium’s Favorable Safety and Tolerability Profile;...
– Pivotal B-Well data show significant 19% functional cure rate in the overall study population and 26% in patients with lower viral activity, compared to 0% with standard of care – – 49% of bepirovirsen recipients achieved a surface antigen level of ≤100 IU/mL one year after end of treatment in
Expanded safety, subgroup, progression-free survival sensitivity and subsequent therapy analyses further characterize the consistency and durability of outcomes observed with zanidatamab-containing combinations in the first-line setting Additional subgroup analyses to be presented at the 2026 ASCO
New analyses examine Afrezza across pediatric A1c and efficacy, patient treatment satisfaction, use with AID algorithms and investigator-led research in pregnancy Late-breaking comparative data vs. rapid-acting insulin analogs to be presented June 7 Nine posters showcase new clinical and real-world
48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau Exploratory FibroScan Assessments Demonstrated Early Liver-Related Improvements Ongoing Phase 1 Part 3a/3b Titration Studies Continue to Evaluate Extended Treatment at Higher-Dose Levels CAMBRIDGE,
Concurrent improvement across key non-invasive tests underscores convergence of pemvidutide effects on MASH disease activity and fibrosis AI-based digital pathology analyses further demonstrate antifibrotic effects of pemvidutide at 24 weeks GAITHERSBURG, Md., May 27, 2026 (GLOBE NEWSWIRE) --
Phase 3 trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI Day 1 and Day 15 initiation dosing and a new single infusion on Day 1 only Safety and tolerability of the consolidated first infusion were consistent with the established BRIUMVI
NEW HAVEN, Conn. --(BUSINESS WIRE)--May 27, 2026-- Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today announced that topline results from Phase 2/3 ‘302’ Study of
BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study. Participants with Graves' overt hyperthyroidism,
RESEARCH TRIANGLE PARK, N.C., May 27, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present seven abstracts from its hereditary angioedema (HAE) portfolio at the Annual Meeting of the European Academy of Allergy and Clinical Immunology
EscharEx ® Phase III VALUE trial advancing; interim assessment and enrollment completion expected by the end of the first quarter of 2027 First quarter revenue of $1.5 million; full-year 2026 revenue guidance reaffirmed at $24-26 million Conference Call Today, May 27, 2026, at 8:30 a.m.
Additional Data Presented Demonstrate High In Vitro Antiviral Potency and In Vivo Efficacy for AT-587, Atea’s Potential First-in-Class Direct-Acting Antiviral for the Treatment of Hepatitis E Virus BOSTON, May 27, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc.
Phase 1 clinical data poster selected as a Best of EASL 2026 presentation Combination of denifanstat and resmetirom was generally well-tolerated in Phase 1 clinical trial Phase 1 data show rapid reductions in cholesterol levels, suggesting the potential for a cardiovascular benefit SAN MATEO,
- Announced first patient dosed in Phase 1/2a clinical trial of GLIX1 for treatment of glioblastoma (GBM) - - Announced new GLIX1 data demonstrating potent anti-tumor effect in GBM across multiple in-vivo studies, including a temozolomide (TMZ)-resistant patient-derived xenograft model - -
- Targeting Activin E may represent a novel therapeutic strategy for metabolic dysfunction-associated steatohepatitis (MASH) and obesity‑related metabolic dysfunction - ARO-INHBE produced meaningful reductions in liver fat content as a monotherapy or in combination with low-dose tirzepatide in
Up to $1.3 billion in flexible, non-dilutive capital, including up to $800 million of synthetic royalty and access of up to $500 million in senior corporate debt Combined with company's current total cash of $1.3 billion, this transaction positions Apogee to achieve a self-sustainable financial
APEX Part B met all primary and secondary endpoints with high statistical significance; mid-dose zumilokibart planned to advance into Phase 3 trials in moderate-to-severe atopic dermatitis (AD) in 2H 2026 Zumilokibart was well tolerated with a safety profile consistent with other agents in class
- New biopsy data demonstrate that PBGENE-HBV directly eliminated cccDNA through its primary mechanism leading to a 1-log (10-fold) reduction in cccDNA-derived transcripts - - In the
27 May 2026 US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for camizestrant in combination...
LA JOLLA, Calif., May 26, 2026 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the completion of last patient last visit (LPLV) in its Phase 2
Webcast to be held Wednesday, May 27th at 8:00 a.m. ET SAN FRANCISCO and BOSTON, May 26, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest
- New data support potential use of plozasiran without dose adjustment in patients with moderate-to-severe renal or moderate hepatic impairment - Case report suggests that preconception exposure to plozasiran may be associated with sustained lowering of fasting triglyceride levels throughout the
Trop-2 H-scores Above 100 and PTEN H-scores Below 100 Correlated With Longer Progression Free Survival in Non-Small Cell Lung Cancer Patients Identified Biomarkers May Predict Patient Response, Enable Targeted Patient Selection and Allow for Precision Medicine AUSTIN, Texas — (May 26, 2026) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ:...
GSK will present new data from its expanding oncology portfolio and pipeline at ASCO and EHA.
- Dialysis access requires frequent cannulation, often exceeding 300 needle punctures annually - - The ATEV was observed to maintain long-term structural integrity and self-repair with smooth muscle cell repopulation despite repeated cannulations - - Humacyte anticipates that top-line interim
NEW YORK, May 26, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI ® (ublituximab-xiiy) data in adults with relapsing forms of multiple sclerosis (RMS) at the 2026 Consortium of Multiple Sclerosis Centers
In a randomized, placebo-controlled, time-to-event trial in idiopathic generalized epilepsy (IGE), the median time to the second day with a generalized tonic-clonic seizure was 141 days in the opakalim 75 mg once-daily treatment group vs. 47 days in the placebo group, representing a 3-fold
New and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies Initial data from the first multi-dose cohort of RA study to be presented Initial data from the first multi-dose cohort of velinotamig study also to
WELLESLEY HILLS, Mass., May 26, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced upcoming presentations for its CLYM116 and budoprutug programs at the European Renal
Study to evaluate OP-3136, Olema’s novel KAT6 inhibitor, in combination with darolutamide in approximately 36 patients; expected to initiate in H2 2026 First clinical collaboration for OP-3136; results to inform combination strategy in metastatic prostate cancer setting SAN FRANCISCO, May 26, 2026
NEW YORK, May 26, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations of new AUVELITY ® data in major depressive disorder at the American Society of
— Company to Present 11 Posters Demonstrating Commitment to Advancing Innovative Research for People Living With Chronic Psychiatric and Neurological Disorders — DUBLIN --(BUSINESS WIRE)--May 26, 2026-- Alkermes plc (Nasdaq: ALKS) today announced plans to present clinical and real-world data
– Tumor shrinkage observed in 77% of response-evaluable patients, including in heavily pretreated and KRASi-experienced patients – – ORRs were 67% in PDAC, 50% in NSCLC, and 29% in KRASi-naïve CRC patients – – Results reinforce darlifarnib’s potential as a precision combination agent across
Basel, May 26, 2026 – Novartis will present data from 15 abstracts from its kidney portfolio at this year’s European Renal Association (ERA) Congress in Glasgow, June 3-6. The presentations reinforce our ambition to advance scientific understanding across progressive immune-mediated kidney diseases and support the evolution of kidney care.
In the Phase 1b Heart-2 trial, a single intravenous infusion of VERVE-102 produced dose-dependent lowering of PCSK9 and LDL-C, with both reductions sustained over follow-up of up to 18 months in participants at high risk for cardiovascular disease VERVE-102 is designed to mimic the protective
Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data from Study 108, a Phase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose De-Escalation in Patients with Ulcerative Colitis Interim intent to treat (“ITT”) analysis from Study 108 supports strong
INDIANAPOLIS, May 22, 2026 – Eli Lilly and Company (NYSE: LLY) announced a new analysis from the Phase 3 ATTAIN-1 and ATTAIN-2 trials showing that Foundayo (orforglipron), was associated with clinically significant body weight reductions in adults aged 65 and
AC Immune Presents New Phase 1 Data Indicating Higher Uptake of TDP-43 PET Tracer ACI-19626 in Patients with ALS Presentation at 2026 TDP43 Summit shows ACI-19626 detects TDP-43 pathology in patients with amyotrophic lateral sclerosis (ALS) Previously reported data also showed detection of TDP-43
Pumitamig data from the ongoing Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig in combination with chemotherapy Gotistobart Phase 2 overall survival data in patients with
ROCKVILLE, Md. and SUZHOU, China, May 21, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to
~ Growing Independent Research Efforts are Expanding Evidence Base Around How PEDMARK ® (sodium thiosulfate injection) May Benefit Broader and More Diverse Patient Populations ~ ~ Real-World Evidence Shows Administration of PEDMARK ® Approximately Six Hours After Cisplatin Can Be Safe & Easily
The Phase 2b LUMA study of BIIB122 in early-stage Parkinson’s disease did not meet its primary or secondary endpoints Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122 in idiopathic Parkinson’s disease Denali continues to independently conduct the
The Phase 2b LUMA study of BIIB122 in early-stage Parkinson’s disease did not meet its primary or secondary endpoints Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122 in idiopathic Parkinson’s disease Denali continues to independently conduct
LONDON and GAITHERSBURG, Md., May 21, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, announces the online publication of an abstract
EL MONTE, Calif. --(BUSINESS WIRE)--May 21, 2026-- Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established laboratory services business and a therapeutic development business, today announced that its full abstract has been released on
Normalization of free light chains occurred by day 15 across all doses 100% of patients achieved a hematologic complete response (CR) at the highest tested dose Majority of patients with renal or cardiac involvement demonstrated improvement in organ function, despite short follow-up First results
– Oral presentation will highlight favorable outcomes observed among 21 adults and children with KMT2Ar, NPM1m, or NUP98r acute leukemia who received revumenib post-transplant – – Data underscoring unique aspects of revumenib’s PK profile, including the ability to administer it with gastric acid
OP-3136 monotherapy was well-tolerated with no dose-limiting toxicities observed and no discontinuations due to treatment-related adverse events OP-3136 shows evidence of anti-tumor activity across multiple solid tumor types Data support the ongoing Phase 1 evaluation of OP-3136 as a monotherapy
CTX-8371, a novel dual checkpoint blocker that simultaneously targets the programmed death receptor PD-1 and its ligand PD-L1, demonstrated promising monotherapy clinical activity in patients with advanced malignancies resistant to prior immune checkpoint inhibitors.
Updated Phase 2 CRDF-004 data to be presented during ASCO 2026 rapid oral session on June 2, 2026; investor webcast scheduled for June 3, 2026 at 8:30 am ET to review the data SAN DIEGO, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology
Phase 3 LIBRETTO-432 study evaluating Retevmo (selpercatinib) as adjuvant therapy in RET fusion-positive NSCLC to be featured in the Plenary Session and ASCO press program Investigator-initiated study of Verzenio (abemaciclib) in patients with advanced dedifferentiated liposarcoma also selected for
– Findings in neuroendocrine tumors, kidney cancer, advanced colorectal cancer and other tumors to be presented – ALAMEDA, Calif. --(BUSINESS WIRE)--May 21, 2026-- Exelixis, Inc. (Nasdaq: EXEL) today announced presentations for its flagship product, CABOMETYX ® (cabozantinib), and its
In the dose optimization stage of the randomized Phase 2 trial (Duravelo-2), zelenectide pevedotin at its optimal dose in combination with pembrolizumab demonstrated response rates comparable to published data for standard of care (SOC) in patients with previously untreated metastatic urothelial
REDWOOD CITY, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that members of Revolution Medicines’ senior management team will host a
BOSTON, May 21, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that patient enrollment has been completed in its randomized,
BEDFORD, Mass., May 21, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced new radiodiagnostic data to be
SAN DIEGO, May 21, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases,
- Webcast with Hepatitis B experts to discuss new biopsy and clinical data from the ongoing ELIMINATE-B trial in chronic hepatitis B - - Webcast will be held May 27 th, 2026, at 8:00 AM EDT - DURHAM, N.C. --(BUSINESS WIRE)--May 21, 2026-- Precision BioSciences, Inc.
BOSTON --(BUSINESS WIRE)--May 21, 2026-- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that data from its
– Real-World Evidence of Positive Impact of LYBALVI ® (olanzapine and samidorphan) on Treatment Patterns and Rates of Relapse Among Patients with Schizophrenia or Bipolar I Disorder, Including Young Adults – – APA Plenary Presentation Highlights Recent Clinical Data, Including Results for Negative
In TRIUMPH-1, participants on 12 mg retatrutide lost an average of 70.3 lbs (28.3%) over 80 weeks with 45.3% of participants achieving ≥ 30% weight loss, a level long associated with bariatric surgery Individuals with a baseline BMI ≥ 35 who participated in a study extension continued to lose
– Of first 20 patients, all four MRD-negative patients have converted to complete response (CR) – – CR rate now 95% (19 of 20 patients) – – All CRs reached within 1 year of follow-up post-dosing – – No relapses to-date observed for patients who have reached CR – – All subsequently enrolled patients for whom MRD results are available are MRD-negative at one...
Basel, May 21, 2026 – Novartis will present data from more than 65 company or investigator sponsored abstracts at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress.
Net revenue increased 816% in Q1 2026 vs. Q1 2025, and increased 527% in Q1 2026 vs. Q4 2025, buoyed by license of U.S. commercial rights for Mytesi ® and Canalevia ® -CA1 Company continues its focus on crofelemer development efforts for rare-disease intestinal failure indications; two crofelemer
In SELVA Phase 3 study, 100% of participants (13/13) aged 6–11 years were rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) scale at Week 24, with a mean improvement of +2.46 (p
agenT-797 demonstrates pathogen suppression, lung immune restoration and tissue repair activation, supporting Ongoing Phase 2 trial Sequential immunotherapy with agenT-797 and N-803, an FDA-approved IL-15 superagonist, Anktiva® may provide impactful clinical combination targeting Coccidioides
IMVT-1402 showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70 at Week 16 in the open label period of its trial in difficult-to-treat rheumatoid arthritis (D2T RA); Immunovant will provide further updates on this program in the second half of calendar year 2026
First MVID patient enters the active treatment only extension phase after completion of randomized double-blind crossover period to evaluate longer-term safety and efficacy with liquid oral crofelemer as adjunctive treatment for MVID, an ultrarare pediatric disease with a lethal natural history and
BEDFORD, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced data to be featured at the 2026
NAI+BCG versus Nadofaragene Results: NAI+BCG treated patients were twice as likely to achieve a complete response (CR) at any point of the study versus nadofaragene firadenovec-vncg in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary
- Safety and efficacy results from the Phase 3 INDIGO trial to be presented by Emanuel Della Torre, M.D., Ph.D., on Thursday June 4, 2026, at 2:45 PM GMT - WALTHAM, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a
Favourable trends seen in stability of disability and clinically meaningful improvements in fatigue. BOSTON, May 19, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana"), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3
Promising initial efficacy data with 60% volumetric response rate across doses and 29%* at the lowest tested dose of 100mg twice daily (BID) with all patients ongoing Interim investigator- and patient-reported outcomes show 89% and 79% of patients achieved clinical improvement at week 12,
New giredestrant data from the lidERA study on its potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease Overall,...
CAMBRIDGE, Mass., May 18, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that initial clinical data from two
IPAX-2 study of TLX101-Tx (¹³¹I-iodofalan) has completed patient enrolment. Maximum dose reached with no dose-limiting toxicities observed. TLX101-Tx is also the subject of a pivotal trial, IPAX BrIGHT, which is actively dosing patients with recurrent glioblastoma.
Data reinforce WVE-006’s potential to address both lung and liver manifestations of AATD with a durable, convenient, and safe therapy capable of recapitulating the protective MZ-like phenotype with monthly dosing On track for feedback from FDA on potential accelerated approval pathway mid-2026
Presentation Features Additional Data from the Single-dose Cohorts of the Phase 1/2 Trial, Including Detailed Safety Results, Efficacy Durability and Reduction in Human Neutrophil Elastase Activity Post-BEAM-302 Treatment CAMBRIDGE, Mass., May 18, 2026 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc.
– Verekitug led to statistically significant and clinically meaningful improvement in asthma symptom control as measured by the Asthma Control Questionnaire-6 (ACQ-6) in participants with CRSwNP and comorbid asthma – – Verekitug led to improvements in nasal polyp score (NPS) in participants with
CALABASAS, Calif., May 18, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company advancing two Phase 2 programs in central nervous system (CNS) cancers, today announced financial results for the first quarter
Three Late-Breaking Posters Highlight DA-1726, a GLP-1 /Glucagon Dual Agonist, and Vanoglipel, a GPR119 Agonist CAMBRIDGE, Mass., May 18, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that
Event will provide an overview of Lymphatic Malformations, the treatment landscape and the TARA-002 clinical program NEW YORK, May 18, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company committed to advancing transformative therapies for the
DT-216P2 demonstrated dose-dependent improvement in multiple clinical measures and increases in endogenous frataxin mRNA and protein after four weeks of intravenous dosing DT-216P2 generally well-tolerated Data support advancement toward registrational development Management to host conference call
Sac-TMT is the first TROP2 ADC to improve OS and PFS compared to chemotherapy in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy in a global Phase 3 study RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE:...
CARLSBAD, Calif., May 17, 2026 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, will announce data from the ongoing Phase 1/2 RESTORE-FA trial evaluating DT-216P2 in patients with
Basel, May 17, 2026 – Novartis today announced new data from PSMAddition demonstrating improved prostate-specific antigen (PSA) responses with Pluvicto ® (lutetium (177Lu) vipivotide tetraxetan) combined with standard of care (SoC) in PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC)....
Data presented by Johnson & Johnson at the 2026 European Society for Radiotherapy and Oncology (ESTRO) Annual Meeting PARIS and CAMBRIDGE, Mass., May 17, 2026 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering
Positive Phase III readout of National Cancer Institute sponsored SWOG S1602 randomized clinical trial demonstrating non-inferior efficacy of the Tokyo strain of BCG ( Tokyo -172 BCG) versus TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer ImmunityBio to serve as sole U.S.
The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) A numeric improvement of 5.1 months in median PFS was observed for the high-dose fianlimab combination compared to pembrolizumab monotherapy Phase 3 head-to-head trial of the
HOUSTON, May 15, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announces financial results for the first
Extended follow-up data from the phase 3 study (20 months after reported topline data, median follow-up 58 months) confirmed a statistically significant and clinically meaningful improvement in prostate cancer–specific disease-free survival (DFS) of 39% after aglatimagene administration compared to
On track to complete enrollment for the Phase 3 PROACT 1 accelerated approval analysis of rilparencel in mid-2026; anticipate pivotal topline results in Q2 2027 Peer-reviewed results from the Phase 2 REGEN-007 study were published in the Clinical Journal of the American Society of Nephrology
SAN DIEGO, May 15, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), (“Belite Bio®” or the “Company”), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today
- High CR rates at any time observed in the CIS-containing population with 85.7% and 92.3% in the ITT population and Efficacy Evaluable population, respectively - High-Grade - EFS in the overall intention-to-treat population was 96.0% at 3 months and 89.5% at 6 months - Efficacy was comparable
PRINCETON, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) durability of response (DOR) at six months by
Completed enrollment in first cohort of Phase 1b challenge study evaluating CDI-988 as a preventive and as a treatment for norovirus infection, began enrollment in prevention and treatment cohorts Highlighted CDI-988’s mechanism of action and clinical advancement at ICAR 2026 Granted FDA Fast Track designation for CDI-988, enabling the potential for an...
Company to continue development of efzofitimod in pulmonary sarcoidosis following Type C meeting with the FDA. Company plans to submit an IND in June 2026 for a Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as
100% of patients with bleeding at baseline demonstrated a statistically significant improvement on the Cutaneous Venous Malformations Investigator Global Assessment Bleeding scale (cVM-IGA Bleeding) at Week 12 (+2.5 point improvement; p=0.003) 100% of patients with bleeding at baseline reported
Randomized Phase 2 trial initiated for agenT-797 in severe acute lung injury and respiratory distress, with preliminary data expected in the second half of 2026 AACR and ASGCT presentations showcase durable survival and context-dependent iNKT activity in cancer and inflammatory lung disease
Late-breaking presentation at SID and featured presentation at the ATS Respiratory Innovation Summit highlight KT-621 BroADen Phase 1b clinical data and potential across Type 2 inflammatory diseases KT-621 parallel Phase 2b trials, BROADEN2 in atopic dermatitis and BREADTH in asthma, ongoing with
TARA-002 demonstrates 72% complete response rate at any time, 67% complete response rate at the 6-month landmark and 55% complete response rate at the 12-month landmark in BCG-Naïve patients Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse
All Patients Achieved Meaningful Decreases (Mean = 64%) in Daily Premature Ventricular Contraction Count TN-401 Gene Therapy was Well Tolerated at 3E13 vg/kg and 6E13 vg/kg Doses Post-dose Biopsies Provide Evidence of TN-401 Activity in Heart Muscle Cells PRIME Designation Granted by European
Q1 2026 total revenue of $22.7 million including neffy ® (epinephrine nasal spray) U.S. net product revenue of $17.5 million CVS Caremark proposal in final stages of approval process; definitive update anticipated in early June Sales force expansion to 148 representatives completed Phase 2b CSU
Announced positive interim data from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with relapsed/refractory multiple myeloma (rrMM) Announced Cincinnati Children’s Applied Gene and Cell Therapy Center (“AGCTC”) as Lead Manufacturing Partner Appointed Andrew Fang, Ph.D., as Head of
Completed successful End-of-Phase 2 meeting with the FDA and selected onvansertib dose and chemotherapy regimen for planned Phase 3 trial Company to provide detailed data update from Phase 2 CRDF-004 trial in rapid oral presentation at American Society of Clinical Oncology Annual Meeting
– Late - breaking oral presentation of Phase 3 envudeucitinib data in moderate - to - severe plaque psoriasis (PsO) at the 2026 American Academy of Dermatology (AAD) Annual Meeting demonstrating early and robust improvements in skin clearance, quality of life, and symptoms – – Data showed robust
48 mg Phase 1 Data Demonstrated Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Key Milestone Achieved with Dosing of the First Patient in Phase 1 Part 3 16-Week Titration Study Evaluating 48 mg (1-Step) and 64 mg (2-Step)
Q1 2026 product sales of $24.3 million, representing 73% growth over Q1 2025 Raising full year revenue guidance - now expect 2026 revenue to exceed $120 million, up from previous guidance of $110 million Q1 2026 fully diluted GAAP EPS of $0.05, non-GAAP fully diluted EPS of $0.14, and Adjusted
Phase 3 VIKTORIA-1 trial achieved primary endpoint with clinically meaningful improvement in progression-free survival in PIK3CA mutant cohort; detailed data for gedatolisib regimens will be presented at the 2026 ASCO Annual Meeting Phase 3 VIKTORIA-2 trial expanded to include a second study
WILMETTE, Ill., May 14, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced first quarter 2026 financial results and provided business updates....
Positive Data from Named Patient Program and Positive Interim Data from Ongoing Phase 2 Clinical Trial Segment featuring Professor Doctor Casper H.J. van Eijck, Professor and Pancreato-biliary Surgeon at Erasmus MC and an oncology consultant for AIM ImmunoTech, is now available on demand here OCALA, Fla., May 14, 2026 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc....
Interim analysis demonstrated a 55.0% relative reduction in proteinuria versus placebo at 39 weeks with eGFR remaining stable through treatment Results further support the potential for telitacicept to become a best-in-class dual BAFF/APRIL therapy across autoimmune diseases BOSTON, May 14, 2026
Company plans to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene or CAN-2409) in localized, intermediate- to high-risk prostate cancer in Q4 2026 Announced purpose-built commercial partnership with EVERSANA ® to support potential U.S.
Multidimensional analyses demonstrate that repeated DeltEx DRI dosing preserves immune function, drives tumor microenvironment remodeling, and correlates with improved survival outcomes in glioblastoma Translational data combines advanced artificial intelligence (AI), immunogenomics,
Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office MINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development
NEW HAVEN, Conn. --(BUSINESS WIRE)--May 14, 2026-- Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today announced that two E-posters will be presented at the 2026
Randomized Phase 2 trial evaluates off-the-shelf invariant natural killer T (iNKT) cell therapy in patients with acute lung injury and hypoxemic respiratory failure Study initiates in Lviv, Ukraine, in partnership with First Lviv Medical and UNBROKEN Ukraine, expands development into a high-acuity
Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE ® study of RGX-202 Primary endpoint achieved with high statistical significance Statistically significant correlation between RGX-202 microdystrophin expression and functional improvement (NSAA, n=9), supporting
- Based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development; CELIA did not meet its primary endpoint assessing dose response - - Robust reductions in tau pathology were observed across all studied doses, with results generally
Achieved Q1 2026 PEMGARDA ® (pemivibart) net product revenue of $13.7 million, representing 22% growth versus Q1 2025 net product revenue of $11.3 million Invivyd in vitro data showed continued neutralizing activity of pemivibart and VYD2311 against SARS-CoV-2 variant BA.3.2.2 (“Cicada”),
Updated micvotabart pelidotin (MICVO) Phase 1 monotherapy data in 2L+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) on track for mid-year 2026; update to include analyses focused on patients treated at or below a dose cap Completed target enrollment in Phase 1 monotherapy
WELLESLEY HILLS, Mass., May 14, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced an upcoming presentation on its budoprutug program at the European Hematology
Foralumab is the first intranasal immune modulator in clinical trials for patients with Multiple System Atrophy BOSTON, May 14, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully
Achieved primary endpoint with high statistical significance; 93% of patients achieved microdystrophin expression above 10% (p
Intending to initiate rolling BLA seeking accelerated approval with submission of nonclinical and clinical modules in June 2026; submission of the final modules including the CMC module expected in second half of 2026 Cross-species nonclinical findings that support skin frataxin levels as a
New immunologic and biomarker data supports the potential of ITK inhibition with soquelitinib to increase persistent Treg cells and influence multiple inflammatory pathways. Data supports potential for soquelitinib to rebalance the immune system and produce drug-free remissions following
CELIA did not meet its primary endpoint assessing dose response; based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development Robust reductions in tau pathology were observed across all studied doses, with results generally consistent
~ Achieved First Quarter 2026 Total Net Revenues of $15.1 Million, Up 73% Year Over Year ~ ~ Field Sales Expansion Showing Early Signs of Positive Results with Record PEDMARK ® Demand in April 2026 ~ ~ Initiated Third Institution-Led Clinical Study Evaluating PEDMARK ® in Adolescent and Young Adult
14 May 2026 Perioperative Imfinzi plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the Phase III VOLGA trial Perioperative Imfinzi plus Imjudo and neoadjuvant EV showed a statistically significant and clinically meaningful improvement...
ORKA-001 EVERLAST-A 16-week data showed 63.5% PASI 100 rate and a favorable tolerability profile, with longer-term data expected in 2H 2026 ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027 Post-offering cash, cash equivalents and marketable securities expected to
Planned Interim Futility Analysis from Pivotal Phase 2 ALPHA3 Trial Supports Cemacabtagene Ansegedleucel’s (Cema-Cel) Potential as an Outpatient, MRD-Guided Consolidation Therapy in 1L Large B-cell Lymphoma (LBCL) 58.3% (7/12) of Patients in the Cema-Cel Arm Achieved Minimal Residual Disease (MRD)
Phase 3 CATT1 completion of enrollment on track for the third quarter of 2026 Strong balance sheet expected to fund operations through anticipated CATT1 topline data readout HIGH POINT, N.C., May 13, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical
Manufacturing operations divestiture sharpens focus on core capabilities in novel drug discovery and development Manufacturing divestiture and expanded monetization of ZYNYZ royalty anticipated to provide up to $202.5 million in combined proceeds ADC pipeline remains on track for multiple data
RECLAIM – LN, a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis, on schedule to initiate in the 2 nd half of 2026 FDA selects FT819 into the CDRP ( CMC Development and Readiness Pilot)
- Advanced " dabogratinib 3x3 " strategy to pursue 3 late-stage clinical studies in LG-UTUC, IR NMIBC and ACH - - First LG-UTUC patient dosed with dabogratinib in SURF303; initial results expected in 2027 - - Initial Ph2 data readout from SURF302 expected in August 2026 (n>20 enrolled to date) - -
The Company intends to submit a Biologics License Application (BLA) for TARA-002 in Lymphatic Malformations (LMs) in 2H 2027 Hosting virtual investor webinar discussing LMs program with key opinion leader (KOL) perspectives on May 19, 2026 at 4:30 pm ET Interim safety and durability data from
Long-Term TA-ERT Data Presented at the 22nd Annual WORLDSymposium™ Highlight Rapid and Durable Reduction of Heparan Sulfate and Stabilization of Cognitive Function in Patients with MPS IIIB Strengthened Leadership Team Across Commercial, Clinical Development, and Regulatory Functions to Support BLA
Initiation of PERFORMA Phase 3 MASH trial planned for second half 2026 $535 million in cash, cash equivalents and short-term investments as of April 30, 2026 Webcast to be held today at 8:30 a.m. ET GAITHERSBURG, Md., May 13, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc.
Initiated NDA Submission to the FDA for D-PLEX₁₀₀; Completion Expected Imminently U.S. Commercial Partnership Discussions in Late Stages Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the
Abstract presenting 48-week IMPACT Phase 2b efficacy and safety data selected for inclusion in “Best of EASL 2026” by EASL Oral presentation will highlight further the 48-week IMPACT efficacy and safety data Late-breaker abstract featuring new digital pathology analysis of liver fibrosis regression
– Company rapidly advancing Phase 3 programs designed to deliver best-in-class efficacy with convenient quarterly dosing in severe asthma and CRSwNP – – End-of-Phase 2 meetings with FDA planned for mid-2026; Phase 3 initiations in both indications expected in Q1 2027 – – Phase 2 VENTURE trial in
BOSTON, May 13, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that three abstracts have been
RNS Number: 1044E PureTech Health PLC 13 May 2026 13 May 2026 PureTech Health plc PureTech to Showcase Deupirfenidone Program at the American Thoracic Society International Conference Presentations to highlight differentiated approach to advancing deupirfenidone, reinforcing its potential to
- Appointed Jim Mercadante as Chief Commercial Officer and Dr. Todd Rasmussen as Chief Surgical Officer - - First quarter sales of Symvess® were $0.5 million in 2026 compared to $0.1 million in 2025 - - Purchase commitment received for a minimum of $1.475 million for a clinical evaluation and
- Phase 1 trial designed to evaluate the safety, tolerability, and pharmacokinetic properties of ZB021 in healthy volunteers and to establish proof-of-concept in patients with plaque psoriasis - - Phase 1 SAD and MAD data expected by year-end 2026, with proof-of-concept data in psoriasis patients
Oversubscribed $30 million private placement closed, with proceeds expected to support ongoing development of APR-1051 Two partial responses observed with continued encouraging tolerability in the ongoing Phase 1 dose escalation ACESOT-1051 trial of WEE1 inhibitor APR-1051 Additional clinical data
– Appointed Globally Renowned Biopharmaceutical Executive and Neurology Drug Developer, Michael A. Panzara, M.D., M.P.H., as Chief Medical Officer – – Continued to Execute Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis, with Top-Line Data Expected by End of 2026 – – Raised $200 Million in an Oversubscribed Private Placement,...
– Obexelimab marketing applications for the treatment of IgG4-RD on-target for submission to the FDA this quarter and the EMA in H2 2026 based on the Phase 3 INDIGO IgG4-RD trial results – – Obexelimab Phase 3 INDIGO IgG4-RD trial results accepted for oral presentation at EULAR 2026 – – Obexelimab
ROCKVILLE, Md. and SUZHOU, China, May 12, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, integrated biopharmaceutical company engaged in the discovery, development and commercialization of innovative therapies for cancers and other diseases,
In ATTAIN-MAINTAIN, participants who transitioned from a maximum tolerated dose (MTD) of Wegovy (semaglutide) to Foundayo maintained all but 0.9 kg of their previously achieved weight loss on average after one year In ATTAIN-MAINTAIN and SURMOUNT-MAINTAIN, participants who switched from Zepbound
Advancing potentially best-in-class once-daily oral, locally-activated PDE4 inhibitor prodrug for treatment of IBD Phase 2 Ulcerative Colitis (UC) trial expected to commence 3Q 2026 Strong balance sheet expected to support execution through key clinical readouts Denver, CO, May 12, 2026 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq:...
- Duchenne (SGT-003): First participant dosed in the Phase 3 IMPACT DUCHENNE clinical trial, receipt of positive opinion on the Company’s Pediatric Investigation Plan from the European Medicines Agency and Orphan drug designation from the European Commission mark important advancements in the
Next anticipated Revita ® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for
REDWOOD CITY, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia cause...
– FREEDOM2-DM1 5 mg/kg cohort demonstrated favorable safety, splicing and vHOT data, with the totality of results supporting the potential of the ongoing 10 mg/kg dose cohort – – The FREEDOM2 10 mg/kg cohort is fully enrolled, with data on track for 2H 2026 – – Well-funded with $132.3M of cash as
Dosed ~90% of participants in Embolden™ registrational trial of NGN-401 for Rett syndrome; on track to complete dosing in the second quarter of 2026 NGN-401 has been generally well-tolerated, with no cases of HLH at the 1E15 vg dose; additional interim Phase 1/2 data expected mid-2026 Presentation
Positive pre-BLA meeting with FDA alignment reached on KYSA-8 single-arm trial in stiff person syndrome (SPS); rolling BLA submission initiated Miv-cel pivotal trial primary analysis results in SPS demonstrated robust, durable effect in indication with no approved therapies; launch preparations
– $5.8 million in KOMZIFTI™ (ziftomenib) net product revenue in first full quarter of commercialization – – Robust new patient starts and early launch dynamics, including repeat use, switching and combination adoption, reflect strong early momentum – – Broad and rapid payer access achieved, with >
– Company reports record demand for YCANTH ® as dispensed applicator units grew to 15,302 in Q1 2026, up 12.1% over the previous quarter and 51.3% year-over-year, and has now exceeded 100,000 dispensed applicator units since launch – – Company announces achievement of over 50% of current targeted
Lead Radio-DARPin MP0712 progressing in Phase 1/2a trial with multiple clinical sites opening and initial clinical data expected in 2026 New data on Radio-DARPins’ amenability to range of therapeutic payloads enable isotope-agnostic strategy for expanding pipeline Strong financial position with
– Abstracts highlight strong revumenib activity across the acute leukemia treatment continuum and multiple genetic subtypes – – New real-world data show compelling outcomes and favorable tolerability with revumenib monotherapy and combination use – – Two abstracts highlight encouraging results with
– Oral presentation to feature 99-patient dataset with extended follow-up in newly diagnosed NPM1-m or KMT2A-r AML – – High CRc rates (90–96%) with deep MRD negativity (> 80%) across both subtypes – – Durable responses with median duration of CRc not reached in NPM1-m patients at ~15 months median
Investigator-sponsored study, conducted at the Moffitt Cancer Center, demonstrates safety and efficacy consistent with the Phase 3 IMerge trial in a broader patient population Additional presentations at EHA 2026 and ASCO 2026 include abstracts related to ongoing myelofibrosis and AML clinical
sNDA submission follows agreement with FDA on confirmatory trial, a requirement of the accelerated approval pathway Confirmatory trial designed to demonstrate clinical benefit of mitapivat on reducing transfusion burden in sickle cell disease CAMBRIDGE, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Agios
CAMBRIDGE, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that the company will present updated biomarker data from the BEACON Phase 1/2 clinical trial of
Oral presentation of data from RALLY-MF phase 2 trial of DISC-0974 in patients with myelofibrosis and anemia Additional abstracts highlighting updates on HELIOS open label extension study of bitopertin in EPP, EPP LIGHT study (patient survey on life and health impact of disease), and DISC-3405
BERKELEY, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced two abstracts have been accepted for oral presentations at the 2026 European Hematology Association (EHA) Annual
Pivotal data from APEX trial in Advanced Systemic Mastocytosis accepted for oral presentation; Cogent’s third oral presentation of pivotal data with bezuclastinib at major medical meetings Preclinical data from selective, potent JAK2 V617F program accepted for poster presentation WALTHAM, Mass.
New York, NY - May 12, 2026 - Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today announced upcoming presentations on the BALLI-01 and NATHALI-01 clinical trials, at the European Hematology Association (EHA)...
Detailed results from RISE UP Phase 3 trial of mitapivat in sickle cell disease selected for distinguished Plenary Abstracts Session Company to host investor conference call and webcast during EHA 2026 on Saturday, June 13, at 9:00 a.m. ET ( 3:00 p.m.
Data from pivotal Phase 3 frontMIND trial evaluating tafasitamab (Monjuvi ® /Minjuvi ®) in first-line diffuse large b-cell lymphoma (DLBCL) selected for prestigious Plenary Abstracts Session Oral and poster presentations to feature new data for INCA033989, an anti-mutant calreticulin
– Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD continuing as planned based on independent DMC review of pre-specified interim analysis – – Expect to report topline data from both Phase 2 Seabreeze STAT studies mid-2026 – – $20.2 million private placement financing
Rezatapopt granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of TP53 Y220C positive ovarian cancer New England Journal of Medicine published first-in-human rezatapopt data showing selective reactivation of mutant p53 in advanced solid tumors Rezatapopt New
Patient screening now underway in the Phase 1b/2 study with the latest drug product batch on track to be available to support upcoming dosing; preliminary data anticipated in 1H 2027 Planned Phase 3 clinical trials remain on track for 2027 year-end initiation $104.9 million in cash, cash
Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression on track for Q2 2026 VLS-01 Phase 2 Elumina topline results anticipated in Q4 2026 Consistent, convergent improvements demonstrated in EMP-01 Phase 2a trial across independent clinician-rated and patient-reported
iNKT therapy, agenT-797, delivers context-dependent immune reprogramming showing activation in cancer and anti-inflammatory benefit in ARDS — from the same manufacturing donor batch, without genetic engineering Findings underscore the intrinsic biology of iNKT cells and the manufacturing scale for
Fasedienol nasal spray has been well-tolerated in patients with social anxiety disorder with no new drug-related safety findings after as-needed use in daily life for up to 12 months Clinically relevant improvement in social anxiety over time was observed on both clinician-administered and
Secured equity financing with gross proceeds of $175M in April 2026 Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. planned to initiate in second half of 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Cumulative cash, cash
Positive topline results from Phase 2/3 Study ‘302’ position VDPHL01 to potentially become the first FDA-approved oral treatment for pattern hair loss in nearly 30 years Upsized IPO and follow-on financing generated approximately $766.8 million in aggregate gross proceeds; pro forma cash expected
– First-ever FDA approved PROTAC supports the further development and potential of Arvinas’ pipeline – – Announced FDA Approval of VEPPANU ™ (vepdegestrant) for the treatment of ESR1m, ER+/HER2- advanced breast cancer – – Announced selection of Rigel Pharmaceuticals for the exclusive global rights
On track to report topline data from Phase 3 LEVEL study of TNX-103 in third quarter of 2026 Global Phase 3 LEVEL-2 clinical trial ongoing, enrollment completion anticipated by end of 2027 Strengthened leadership team with appointments of Thomas Staab as Chief Financial Officer and Timothy Healey,
SUPRAME Phase 3 interim and final analysis for PRAME cell therapy, anzu-cel, expected to be triggered in 2026, advancing toward the Company’s first commercial launch planned in 2027 Multiple key clinical data sets expected in 2026 across the portfolio, including four clinical-stage cell therapy and
Enrollment completed in the PreciSION CF Phase 2a proof-of-concept trial evaluating NBD1 stabilizer SION-719 as an add-on to standard of care in participants with cystic fibrosis; topline data on track for the summer of 2026 Ongoing Phase 1 trial evaluating NBD1 stabilizer SION-451 in proprietary
Top-line data from the Phase 3 OPERA-01 trial anticipated this fall; Phase 3 OPERA-02 trial continues to enroll patients First clinical data from OP-3136 Phase 1 study to be presented at ASCO Ended the first quarter with $505.3 million in cash, cash equivalents, and marketable securities SAN
– LUMRYZ Met All Primary and Key Secondary Endpoints Demonstrating Statistically Significant and Clinically Meaningful Improvements Compared to Placebo in Excessive Daytime Sleepiness and Patient-Reported Disease Severity – – Safety Profile Consistent With Known Safety Profile of LUMRYZ – DUBLIN
AX-0810 target engagement data in healthy volunteers on track for Q2 2026; biliary atresia selected as initial Phase 2 indication Pipeline expansion with advancement of AX-0811 (NTCP) and AX-0422 (IDUA) toward the clinic, supporting multiple upcoming clinical catalysts Continued advancement of Axiomer platform, including AI-enabled discovery capabilities,...
Five-year follow-up data from KEYNOTE-942 underscore the continued potential of intismeran autogene (mRNA-4157 or V940) in combination with KEYTRUDA ® (pembrolizumab) for patients with resected high-risk melanoma Results from the final analysis of KEYNOTE-522, evaluating KEYTRUDA in combination with chemotherapy, demonstrate continued survival benefit for...
Company closed PIPE financing with gross proceeds of up to $175 million, including the possible exercise of warrants, from long-term global investors. Proceeds are expected to fund the Company through 2027, including completion of the ongoing Phase 1b clinical trial in Alzheimer's disease (AD)....
ICV is a commonly used neurosurgical procedure performed across multiple therapeutic settings, including gene therapy Presentation adds to body of evidence that ICV administration results in broad biodistribution of gene therapy to the brain and nervous system Use of ICV administration in NGN-401
Successfully completed chronic toxicology studies for icovamenib, providing the nonclinical support for advancing to chronic clinical dosing, beyond the 12-week clinical dosing that has been used to date Topline data reported from the Phase II COVALENT-112 clinical trial of icovamenib in type 1
- First results from CORE-008 Cohort CX Phase 2 Trial evaluating intravesical combination therapy in High-Risk BCG-Exposed and BCG-Unresponsive patients to be presented - - Visit CG Oncology at booth #3051 - DALLAS, May 11, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc.
SAN DIEGO --(BUSINESS WIRE)--May 11, 2026-- Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced two
– LOQTORZI ® net revenue of $11.8 million in Q1 2026 – – Patient accrual complete for 1L HCC Phase 2 randomized clinical trial for anti-IL27 casdozokitug, timing for data readouts tracking to projections – – Tagmokitug, CCR8 Treg depleter development expands with pharmacological and clinical
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026 Phase 1 Clinical Trial Initiated for SEP-479, Oral Small Molecule PTH1R Agonist for Hypoparathyroidism Cash Position of
CAMBRIDGE, Mass., May 11, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that a late-breaking abstract highlighting DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1
Single dose treatment of FT819 without conditioning chemotherapy achieves lupus low disease activity state (LLDAS) in active SLE Patients; durable B cell remodeling is exhibited by depletion of major B cell clones up to 12 months following treatment with B cell shift towards less class-switched BCR
Zumilokibart advancing across multiple indications, with Phase 3 initiation in atopic dermatitis (AD) expected later this year: - APEX Phase 2 Part A 52-week data demonstrated durable maintenance and improved efficacy over time with every 3- and 6-month dosing in moderate-to-severe AD - APEX Phase
Authorization advances Fractyl Health to a dual clinical-stage company, with Revita ® in pivotal development for post-GLP-1 weight maintenance and Rejuva ® entering first-in-human studies for type 2 diabetes First-in-human dosing and preliminary data expected in the second half of 2026, subject to
Preliminary blinded data from ongoing Phase 1 trial demonstrated mean weight loss of 7% (range 0-16%) at 8 weeks in first MAD Part B cohort (n=8, including 2 placebo) MBX 4291 generally well tolerated, only one event of diarrhea, nausea or vomiting through 8 weeks in first MAD Part B cohort MBX
Following alignment discussions with FDA, BLA completion for HR BCG-unresponsive NMIBC is expected fourth quarter 2026 PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC anticipated first half 2026 CORE-008 Cohort CX Phase 2 first
- Data from Phase 1b/2 trial of evorpacept + zanidatamab presented at ESMO Breast Cancer 2026 showed all patients with confirmed HER2-positive disease and high CD47 expression experienced durable responses to this combination - - Evorpacept data from two independent HER2-positive trials strengthens
Plenary session at AANS underscores REYOBIQ’s potential as a differentiated targeted radiotherapeutic platform for CNS cancers HOUSTON, Texas, May 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing
Topline results for the randomized portion of PALISADE-4 are expected in the second quarter of 2026 SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--May 8, 2026-- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to
Advancing next-generation γδ T cell engager platform with initial animal data expected in 2026 Reported glioblastoma (GBM) data showing ~97% improvement in progression-free survival vs. standard-of-care; updated median overall survival (mOS) data to be presented at ASCO 2026 Hosting R&D Day on May
- Positive data announced from Phase 1 Dose Expansion Study of varsetatug masetecan (“Varseta-M”) EpCAM PROBODY® ADC in Patients with Advanced Colorectal Cancer (CRC) - - Enrollment of 40 patients in Varseta-M Dose Optimization completed; data update expected in 2H 2026 to inform monotherapy dose
Reported positive results from aleniglipron Phase 2 ACCESS II study with up to 16.3% body weight loss, demonstrating highest efficacy among oral GLP-1RAs at the 44-week time point and potentially comparable efficacy to injectable GLP1-RAs Data from ACCESS OLE expected in Q3 2026; Data from the
Successfully dosed all four planned healthy volunteer SAD cohorts of ongoing ABS-201™ HEADLINE trial; well-tolerated with favorable emerging safety data Preliminary pharmacokinetic (PK) modeling from HEADLINE trial supports ABS-201's targeted dosing interval Initiated dosing of first MAD cohort of
Jazz announced U.S. FDA acceptance with Priority Review of Supplemental Biologics License Application (sBLA) for zanidatamab in first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA); PDUFA target action date of August 25, 2026 China’s NMPA has
Completion of Lead Clinical Candidate PH-762 Dose Escalation Trial for Treatment of Skin Cancer with Favorable Safety and Pathology Data Key Development Agreements Secured for Nonclinical Toxicology and U.S. cGMP Clinical Supply ManufacturingKing of Prussia, Pennsylvania--(Newsfile Corp. - May 7, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...
SIM0505/CDH6 ADC dose optimization initiated in gynecologic cancers SIM0505 Phase 1 dose escalation study data to be presented at ASCO 2026 LNCB74 Phase 1 dose escalation trial update planned in second half of 2026 BELTSVILLE, Md., May 07, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc.
AVMAPKI® FAKZYNJA® CO-PACK net product revenue of $18.7 million Appointed Daniel Lyons as Chief Commercial Officer to lead next phase of commercial growth Initiated Phase 2 registration-directed trials “VS-7375 TARGET-D Clinical Program” in 2L PDAC, 2L/3L NSCLC and 2L+ CRC VS-7375 TARGET-D 101
TX45 APEX Phase 2 patient enrollment in PH-HFpEF is nearing completion with topline results anticipated in late Q4 2026 or early Q1 2027 TX2100 advanced into Phase 1a healthy volunteer clinical trial in February 2026 as a potential treatment for Hereditary Hemorrhagic Telangiectasia (“HHT”), and as
FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting
Soquelitinib clinical development for atopic dermatitis advancing with Phase 1 cohort 4 positive data and initiation of Phase 2 trial during the quarter New immunologic and biomarker data supporting the potential for drug-free remissions with soquelitinib to be presented at Society for
Enrollment completed six months ahead of guidance in both barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2); Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD)
First presentation of Week 24 results from TRuE-AD4 study in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) at the 2026 EADV Symposium The vast majority of
Final UPMC Primary Endpoint Report Details Positive Data from Ovarian Cancer Clinical Trial Combining Ampligen, Pembrolizumab and Cisplatin OCALA, Fla., May 07, 2026 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American:...
- Data from Phase 1b/2 trial presented at ESMO Breast Cancer 2026 further validate a biomarker-driven development strategy for evorpacept - - Findings are consistent with previous results from the randomized ASPEN-06 trial in HER2-positive gastric cancer, which indicated CD47 expression could
- Initiation of Phase 3 IMPACT DUCHENNE placebo-controlled, randomized, double-blind trial as part of Solid’s integrated, multi-trial development program designed to support registration and global regulatory authorizations for SGT-003 - - Solid received a positive opinion from the European
FDA Pre-New Drug Application (NDA) meeting granted for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, with meeting expected in second quarter of 2026; NDA submission on track for second half of 2026 Accelerating U.S. launch readiness for QTORIN™ rapamycin for
Q1 2026 Revenue Growth with Continued Strong Sales Momentum: $44.2 million, representing an ~168% year-over-year increase compared with Q1 2025 and up 15% from Q4 2025 ANKTIVA ® Unit Growth: 168% increase in unit sales volume in Q1 2026 compared to Q1 2025 ANKTIVA Regulatory Update: ANKTIVA is
-- Announced positive ELEVATE-44-201 Cohort 1 topline results in Duchenne muscular dystrophy showing favorable safety, tolerability and early functional benefit -- -- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026, as well as ELEVATE-44-201 open-label period and Cohort 2 data
ROCKVILLE, Md., May 7, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the 2026 American Society of Gene & Cell Therapy Annual Meeting ("ASGCT 2026") taking place May 11-15, 2026, in Boston, Massachusetts. Oral Presentations: The oral presentations include an
1Q26 Total Revenue of ~$71M Delivers ~ 45% Year-over-Year Growth 2Q26 Revenue Guidance of $86M to $88M and FY26 of $350M to $370M 40% Confirmed Objective Response Rate in Metastatic Serous Endometrial Cancer SAN CARLOS, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc.
Robust B-cell depletion observed with budoprutug subcutaneous formulation in healthy volunteers, supporting continued development CLYM116 modeling and initial Phase 1 safety data to be presented at ERA 2026 with initial Phase 1 PK/PD data expected mid-2026 Budoprutug pMN, ITP, and SLE clinical
Phase 2a follow-up period data for RAP-219 in focal onset seizures (FOS) demonstrated sustained seizure reduction, including a 90% median reduction in clinical seizures over baseline in weeks 9-12 RAP-219 Phase 2 trial in bipolar mania topline results now expected in the fourth quarter of 2026,
Interim clinical data from GFORCE-1 trial of NEK7-directed MGD MRT-8102 demonstrated profound CRP reductions in subjects with elevated CVD risk; readout of expanded GFORCE-1 trial in subjects with elevated CVD risk anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2
Recent BEAM-302 Topline Data in Alpha-1 Antitrypsin Deficiency (AATD) Demonstrate Strong Single-dose Safety and Efficacy Profile, with 60 mg Selected as Optimal Biological Dose; Global Pivotal Cohort Expected to Initiate in Second Half of 2026 Data from Phase 1/2 BEACON Clinical Trial of Risto-cel
-- Achieved the primary objective with favorable safety and tolerability, no discontinuations and no serious adverse events -- -- Markers of kidney function via eGFR, Cystatin C and magnesium were all within normal ranges and comparable to placebo -- -- Observed lower plasma exposure in Cohort 1
- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Unique Dual Mechanism of ATI-2138 Supports Planned Phase 2b Clinical Trial in Lichen Planus - - Strong Cash
Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China’s CDE in March 2026 Completed acquisition of Cullgen in an approximately $300 million
Data contributed to the scientific and clinical rationale for RASolute 302, a pivotal Phase 3 trial in second line treatment of patients with metastatic pancreatic cancer REDWOOD CITY, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing
BOSTON, May 06, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) will announce topline results from Cohort 1 of the double-blind, placebo-controlled, multiple ascending dose portion of the Phase 1/2 ELEVATE-44-201 clinical study of ENTR-601-44 on Thursday, May 7, 2026.
One-Year Cohort 1 Data and Initial Cohort 2 Data from RIDGE™-1 Phase 1b/2 Trial of TN-401 for PKP2-Associated ARVC to be Presented at ASGCT 2026 New Data from Both Cohorts of the MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM Expected in the Second Quarter 2026
PiNACLE pivotal clinical trial evaluating ronde-cel in patients with LBCL in third- or later-line setting on track to report additional data in second half of 2026, with pivotal data expected mid-2027 and BLA submission expected to follow in 2027 PiNACLE-H2H, a first of its kind Phase 3 clinical
Enrollment Now Completed for OPUS-1, OPUS-2 and OPUS-3 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected
COPENHAGEN, Denmark, May 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from a subgroup analysis showing that children with achondroplasia ≥5 years of age at enrollment treated with once-weekly TransCon CNP (navepegritide) in its pivotal ApproaCH Trial
NEW YORK, May 06, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB) (“IN8bio” or the “Company”), a clinical-stage biopharmaceutical company developing innovative gamma-delta (“γδ”) T cell therapies for cancer and autoimmune diseases, today announced a series of presentations at leading medical
NEW YORK, May 06, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB) (“IN8bio” or the “Company”), a clinical-stage biopharmaceutical company developing innovative gamma-delta (“γδ”) T cell therapies for cancer and autoimmune diseases, today announced a series of presentations at leading medical
Patient preference and adherence research highlight potential of long-acting dosing regimens to improve clinical outcomes in severe asthma
-- Company will also report first quarter 2026 financial results and operational highlights -- ROCKVILLE, Md., May 6, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a webcast on Thursday, May 14, 2026, at 8:00 a.m.
EoEHSS (EoE Histology Scoring System) is a standardized method used to monitor esophageal tissue damage in EoE patients. Sub scores of EoEHSS are reported to specifically evaluate the tissue inflammation and tissue architecture (which is a measure of fibrosis) EoEHSS sub scores for inflammation
100% complete response (“CR”) rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 dual-targeting CD19/BCMA CAR-T across two ongoing Phase 1 trials (REDEEM-1 and POEMS-1) Favorable safety profile with no Grade > 3 CRS or ICANS in REDEEM-1 trial evaluating TPST-2003 in
Multiple milestones achieved or on track across wholly owned and partnered programs REC-1245 (RBM39 degrader): Early clinical data in solid tumors demonstrate a well-tolerated safety profile and predictable, dose-dependent pharmacokinetics; no DLTs observed to date, supporting ongoing dose
SAN CARLOS, Calif., May 05, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that three icovamenib abstracts have been selected for late-breaking poster presentations at the
FDA Breakthrough Therapy designation granted to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer, the Phase 3 ReDiscover-2 trial population in 2L breast cancer Presented zovegalisib doublet data at Phase 3 dose in CDK4/6-experienced patients at ESMO TAT, demonstrating 11.1-month
Phase 2 Data Highlight the Observed Abscopal-like Effect of VP-315 in Non-treated Basal Cell Carcinoma Tumors WEST CHESTER, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the
Conference Call and Webcast Today at 8:30 a.m. ET Positive 12-month data from the OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy (GA) indicates a statistically significant (p
Data demonstrate colon tissue PDE4/cAMP pathway modulation and sustained active metabolite exposure above IC90 across the dosing interval Steady-state pharmacokinetic findings provide mechanistic support for previously reported Phase 1b clinical activity Additional findings support PALI-2108’s potential as a once-daily, gut-targeted oral therapy Data...
Completed enrollment of the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP); topline data expected in Q4 2026 Updated data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared at the American Society of Clinical Oncology (ASCO) Annual
Global Phase 3, randomized, controlled trial comparing azenosertib to standard-of-care chemotherapy now enrolling ASPENOVA designed as confirmatory study to support DENALI Phase 2 accelerated approval pathway, pending FDA feedback SAN DIEGO, May 05, 2026 (GLOBE NEWSWIRE) -- Zentalis ®
Announced positive topline induction data from Part A of the Phase 2 SKYLINE trial of SPY001, demonstrating best-in-class efficacy potential and a safety profile consistent with the α4β7 class Announced over-enrollment and acceleration of topline readout to the third quarter of 2026 of the
- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund
As recently announced, tovecimig (DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel demonstrated a highly statistically significant improvement in progression-free survival (PFS) versus paclitaxel alone as well as clear signals of a survival benefit in a Phase 2/3 study of patients
Cross-trial analyses comparing ANKTIVA + BCG with nadofaragene firadenovec-vncg and TAR-200 provide important context, particularly in the absence of head-to-head data, highlighting its efficacy, durability, and safety in patients with CIS ± papillary disease and informing treatment selection and
EREFS is a standardized visual scoring system that gastroenterologists use when performing an endoscopy in EoE patients to assess the severity of inflammation and fibrosis in the esophagus EREFS data reported by Eupraxia demonstrated a relationship between the number of injections of EP-104GI and
- Continued advancement of the Phase 1/2a ELIMINATE-B trial of PBGENE-HBV across multiple dosing cohorts; Late-Breaking poster presentation for PBGENE-HBV accepted at European Association for the Study of the Liver Congress 2026 - - Advanced PBGENE-DMD toward clinical evaluation in the Phase 1/2
Robust B-cell depletion observed with budoprutug subcutaneous formulation in healthy volunteers, supporting continued development Budoprutug pMN, ITP, and SLE clinical trials enrolling to plan; Fast Track Designation received for pMN Initial data from ITP trial anticipated in June; initial data
- REVEAL-2 met its primary endpoint with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates (PRR) at week 24, respectively, versus 15% placebo, both highly statistically significant results (p 0.0001) - - Elegrobart Q4W
Dupixent showed significant and clinically meaningful improvements in both esophageal distensibility as well as disease-related structural changes and inflammation in the esophagus in adult patients with EoE at week 24 compared to placebo, in results presented at DDW These results reinforce the
-- Bempikibart 36-week topline data readout from Part B of SIGNAL-AA Phase 2a clinical trial on-track for mid-2026 -- -- First patient dosed in SIGNAL-AA Part B open-label extension (OLE) -- -- Completed $10.5 million registered direct offering (RDO) -- -- Cash and cash equivalents of $50.8
In LUCENT-3, more than 60% of patients who achieved disease clearance at one year maintained it after four years of continuous Omvoh treatment Disease clearance is a high clinical bar in UC requiring simultaneous symptomatic, endoscopic and histologic remission INDIANAPOLIS, May 5, 2026
PARIS and CAMBRIDGE, Mass., May 04, 2026 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘ Company ’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today
Live webcast on Friday, May 8, 2026, beginning at 12:30 PM ET Event will feature Phase 1 clinical data for BGE-102 and the therapeutic rationale for development in atherosclerotic cardiovascular disease (ASCVD) and retinal disease Four leading academic and clinical experts will join BioAge
SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases,
Conference Call Scheduled for Friday, May 15, 2026, at 1:00 PM ET NEEDHAM, Mass., May 04, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for
Conference Call Scheduled for Friday, May 15, 2026, at 1:00 PM ET NEEDHAM, Mass., May 04, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for
-- Data support potentially best-in-class profile of XmAb942, under evaluation in ongoing global Phase 2b XENITH-UC study on track for 12-week induction results in 2027 -- -- Novel XenLock™ format optimizes bispecifics for treatment of autoimmune diseases; first XenLock™ candidate XmAb412
Clinically significant angiokeratomas represent a rare, chronic and debilitating lymphatic malformation with no FDA-approved therapies and an estimated more than 50,000 diagnosed patients in the U.S. Phase 2 single-arm, baseline-controlled trial expected to enroll up to 15 subjects at leading
PASADENA, Calif. --(BUSINESS WIRE)--May 4, 2026-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events: BofA Securities 2026 Healthcare Conference – May 12-14, 2026 Type: Investor Group Dinner Date/Time: May 12, 2026
Dose optimization will initially be focused on evaluating SIM0505 in patients with platinum-resistant ovarian cancer (PROC) Phase 1 data readout to be presented at ASCO 2026 BELTSVILLE, Md., May 04, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company
$116.4 million in 1Q VYJUVEK global revenue and $846.7 million since launch Enrollment complete in KB803 (corneal abrasions in DEB patients) registrational study On track for KB803 and KB801 (NK) registrational data readouts in 2026 FDA grants platform technology designation for KB407 (CF) and
Natalie Holles, seasoned industry executive with significant rare disease operational and commercialization experience, appointed Chief Executive Officer and President and member of the Board of Directors Acceleration in patient screening driving Phase 3 CoMpass trial enrollment to near completion
ZURICH-SCHLIEREN, Switzerland and Concord, Mass., May 04, 2026 (GLOBE NEWSWIRE) -- Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics, today announced its attendance and presentations
Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting MINNEAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of
Includes results from additional continuous glucose monitoring (CGM)-based outcomes which demonstrate significant and consistent improvements in glycemic control in ersodetug treatment arms compared...
Positive Phase 1 data confirm MP0317’s tumor-localized CD40 activation with a favorable safety profile in patients with advanced cancer types Pharmacokinetic profile of MP0317 well suited for combination treatment settings, including checkpoint inhibitors Randomized Phase 2 investigator-initiated
PITTSBURGH, May 1, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that six abstracts on its investigational low-dose estrogen combined hormonal contraceptive (CHC) weekly patch will be presented at the 2026 American College of Obstetricians and
Latest findings from the DME AWARE Delphi Study on unmet needs in diabetic macular edema (DME) management highlighting the need for non-invasive therapeutic options to be presented by Baruch Kuppermann, M.D., Ph.D. New post-hoc analysis of OCT scans on GCIPL and analysis of responders with
Clinical results of KSI-101 in macular edema secondary to inflammation (MESI) from a tertiary care uveitis practice demonstrate outcomes consistent with results from the U.S. Phase 1b APEX study, supporting continued global development and expansion of the Phase 3 PEAK and PINNACLE program into
- The trial achieved its primary endpoint demonstrating favorable safety and tolerability - Encouraging trends observed across multiple exploratory efficacy endpoints including improvements in measures of pain and other functional patient-reported outcomes - Results support further evaluation of
Ongoing Phase 1b human challenge study with oral, direct-acting protease inhibitor is designed to demonstrate proof-of-concept as a preventive and a treatment Fully enrolled first cohort is assessing the infectivity of the human challenge inoculum There are no approved treatments or vaccines for norovirus, the leading cause of acute gastroenteritis across...
-- Total revenue of $177 million, reflecting increase of 5 percent over first quarter 2025 driven by growth across commercial portfolio, including EXPAREL volume growth of 7 percent -- -- Completed enrollment in Phase 3 registrational study of ZILRETTA in osteoarthritis pain of the shoulder; study
SAN DIEGO, April 30, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases,
- Company Will Discuss Data and Report First Quarter 2026 Financial Results on May 8 - SOUTH SAN FRANCISCO, Calif., April 30, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed
- Solid Biosciences delivers its largest scientific program at the 2026 ASGCT Annual Meeting with 5 oral presentations and 11 posters - CHARLESTOWN, Mass., April 30, 2026 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing
PITTSBURGH, April 30, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the Company will be presenting on multiple programs at upcoming scientific conferences being held in May and June. Presentation details are outlined below.
AC Immune First Quarter 2026 Financial and Corporate Updates Dosed first subjects in Phase 1 trial of brain-penetrant small molecule NLRP3 inhibitor ACI-19764 with SAD/MAD results in healthy volunteers expected in H2 2026 Initiated final cohort, AD4, in ABATE Phase 1b/2 trial of ACI-24 to treat
Presentations at AACR Annual Meeting 2026 underscore significant opportunities for nuzefatide pevedotin in EphA2 expressing cancers, including pancreatic cancer Human imaging data provides further evidence of the potential of EphA2 as a novel cancer target and the positive properties of Bicycle ®
AC Immune Initiates Final Cohort in Ongoing Phase 1b/2 ABATE Trial of Anti-Abeta Active Immunotherapy to Treat Alzheimer's Disease Treatment of first patient in Cohort AD4 in ABATE trial triggers $12 million milestone payment Allows evaluation of potential for precision prevention of
NEW YORK, April 30, 2026 – Immunic, Inc. (Nasdaq: IMUX) , a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced participation in the following investor and medical conferences in May: May 4-6 and 12-13: 26th Bio€quity Europe ....
New real-world data confirm Vabysmo’s potent retinal drying in nAMD and DME Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden Roche will present more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions Basel, 30 April 2026...
TLX597-Tx is a PSMA 1 -targeting small molecule radioligand therapy (RLT) candidate, designed to improve quality-of-life and efficacy in earlier-stage prostate cancer. OPTIMAL-PSMA 2 initial dosimetry data demonstrate low salivary gland and kidney uptake, supporting dose intensification.
--Independent data monitoring committee (IDMC) determined the trial unlikely to meet primary endpoint – --Alector remains focused on advancing its pipeline of novel ABC -enabled candidates, including an anti-Aβ antibody for Alzheimer’s disease (AD), a GCase enzyme replacement therapy (ERT) for
Presentation will showcase recent data from multiple clinical studies evaluating dual-targeting CD19/BCMA CAR-T therapy candidate TPST-2003 Results support clinical benefit of parallel-structure dual-targeting CAR architecture in patients with relapsed/refractory multiple myeloma Data further
- Arkansas Children’s Hospital activated as the first clinical trial site and now enrolling patients in the FUNCTION-DMD study of PBGENE-DMD - DURHAM, N.C. --(BUSINESS WIRE)--Apr. 29, 2026-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel
SOL-X long-term extension trial in wet AMD enrolled the first subject in April 2026 who had successfully completed the two-year SOL-1 trial Subjects who have completed the two-year follow-up in either SOL-1 or SOL-R have an opportunity to enroll in the SOL-X trial for an additional three years
Analysis demonstrates statistically significant reduction in the severity of surgical wound infections, with potential to lower hospital resource utilization following abdominal colorectal surgery PETACH TIKVA, Israel, April 28, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd.
With recent FDA acceptance of the Phase 2a multidose portion of INLIGHT trial of WVE-007 (INHBE GalNAc-siRNA) in individuals with higher BMI, with and without type 2 diabetes, this portion of the trial remains on track to initiate in 2Q 2026 Combination and maintenance trials of WVE-007 on track
Patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology & Co-Director of Brain and Spine Tumor Center, Perlmutter Cancer Center Data from the Phase 1 part of the study anticipated in H1 2027 TEL AVIV, Israel, and OSLO, Norway, April 28, 2026
- Positive Full Results from Phase 1a Trial of Anti-TSLP/IL-4Rα Bispecific Antibody ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Estimated Half-Life of Approximately 45 Days; Unlocks Opportunity for up to
A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6) Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline
Oral and poster presentations highlight progress across cardiac genetic medicine pipeline and optimized, Sf9-baculovirus AAV manufacturing platform NEW YORK, April 27, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering
WAYNE, Pa., April 27, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it will provide the full results from its Phase 1a single and
SAN FRANCISCO, April 27, 2026 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced multiple presentations at the American
NEW YORK, April 27, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, today announced that updated, interim data from Cohort A of the ongoing Phase
Robust monotherapy efficacy in KRAS G12X NSCLC: 62% uORR in 2L+ and 75% uORR in post-ICI/platinum 2/3L at 16-32 mg QD PAD, and 64% uORR in 2L+ at 24-32 mg QD RDE Robust monotherapy efficacy in 2L KRAS G12X PDAC: 40% uORR at 16-32 mg QD PAD, 42% uORR at 24-32 mg QD RDE, and 50% uORR at 32 mg QD
Readout to Include One-Year Cohort 1 Results and Early Cohort 2 Data; Webcast Conference Call Planned to Review RIDGE-1 Data at ASGCT Additional Presentations at ASGCT Showcase Tenaya’s Work with Patients to Advance Gene Therapy and Early-Stage Pipeline Innovations in Cardiac Gene Editing SOUTH
Conference call and live webcast today at 4:30 PM Eastern Time SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK
WOBURN, Mass., April 27, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual
DURHAM, N.C., April 27, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it will host a virtual key opinion leader (KOL) event on
Tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel demonstrated a highly statistically significant improvement versus paclitaxel alone in the key secondary endpoint of median progression-free survival (PFS) of 4.7 months versus 2.6 months, providing a 56% reduction in
BEDFORD, Mass., April 27, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming scientific and investor conferences in May 2026.
SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the Company will host a key opinion leader (KOL) webinar to discuss data
ORKA-001 achieved 63.5% (40/63) PASI 100 at Week 16 Favorable safety profile consistent with the IL-23p19 class Updated Phase 1 PK/PD data continue to support the potential for once-yearly dosing, with longer-term EVERLAST-A data expected in 2H 2026 Management to host a conference call today at
Topline data is on track for anticipated readout in the summer of 2026 WALTHAM, Mass., April 27, 2026 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF), today
VDPHL01, a novel orally-administered extended-release minoxidil formulation, met all primary and all key secondary endpoints with high statistical significance in both active treatment arms evaluating once-daily (QD) and twice-daily (BID) administration of VDPHL01 Rapid and robust hair growth was
-- Company’s extended-release formulation of zinc acetate will be compared to GALZIN® (zinc acetate) and a placebo for the treatment of Wilson disease -- DEER PARK, Ill., April 27, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative
Zovegalisib + atirmociclib + AI selected as triplet regimen for frontline development Compelling efficacy and tolerability data for zovegalisib triplet in median 3L patients 44% ORR in heavily pre-treated, CDK4/6-experienced patients (median third-line); ORR is similar across kinase and non-kinase
Conference call will take place on Monday, April 27, 2026 at 8:00 am ET NEW HAVEN, Conn. --(BUSINESS WIRE)--Apr. 26, 2026-- Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss,
MENLO PARK, Calif., April 26, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, today announced it will report Week 16 data for
Webcast scheduled for Monday, April 27, 2026 at 8:00am ET. BOSTON, April 24, 2026 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases,
Intestinal Failure (IF) occurs in patients with an ultrarare congenital enteropathy due to microvillus inclusion disease (MVID) and/or short bowel syndrome (SBS) Jaguar has received orphan drug designations for MVID & SBS in the US and EU Jaguar has also completed enrollment of pediatric MVID
– Regulatory Filing in Japan Planned Following Clinical Trial Completion – TOKYO and SAN DIEGO, April 24, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) and Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) today announced the first patient has been dosed in a Japanese Phase 2
Expect to report topline data from both studies mid-2026 SAN DIEGO, April 23, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of
Abivax to Present Data on Obefazimod at Digestive Disease Week ® Presentations Highlight Comprehensive Efficacy, Safety, and Patient-Reported Outcomes from the Phase 3 ABTECT Program and Preclinical Anti-Fibrotic Models in Inflammatory Bowel Disease PARIS, France – April 22, 2026 – 10:05 pm CEST –
EL MONTE, Calif. --(BUSINESS WIRE)--Apr. 22, 2026-- Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established laboratory services business and a therapeutic development business, today announced that its abstract was selected to be
NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data highlighting BRIUMVI ® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2026 annual meeting in Chicago.
AUSTIN, Texas — (April 22, 2026) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX ), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators’ abstract has been selected for publication at the upcoming 2026 American Society of Clinical...
- Late-breaking poster presentation to highlight new biopsy data demonstrating elimination and inactivation of cccDNA from the ongoing Phase 1 ELIMINATE-B trial in chronic hepatitis B - DURHAM, N.C. --(BUSINESS WIRE)--Apr. 22, 2026-- Precision BioSciences, Inc.
VANCOUVER, British Columbia, April 22, 2026 (GLOBE NEWSWIRE) -- Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for
RNS Number: 4332B PureTech Health PLC 22 April 2026 22 April 2026 PureTech Health plc PureTech Reports Positive Topline Data from Phase 1b Trial of LYT-200 in Relapsed/Refractory (R/R) High-Risk (HR) Myelodysplastic Syndrome (MDS) and R/R Acute Myeloid Leukemia (AML) Phase 1b dataset with
EMP-01 demonstrated a large, clinically meaningful reduction in patient-reported SAD symptoms at Day 43: placebo-adjusted LSMD -11.5 points (p=0.002) on SPIN; placebo-adjusted LSMD -15.6 points (p=0.004) on SAFE - a 38% and 32% reduction, respectively Patient-perceived global improvement: 49% PGI-C
ROCKVILLE, Md. and SUZHOU, China, April 21, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to
Late-breaking Phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in relapsing multiple sclerosis (RMS) Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide Fenebrutinib could become a...
Single-dose of miv-cel achieved robust and durable improvements in mobility, reversed disability scores, and eliminated the need for chronic immunotherapies – outcomes not previously observed in SPS Data underscore potential for miv-cel to become the first and only approved treatment for SPS,
REDWOOD CITY, Calif., April 21, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced updated clinical data from two Phase 1/2 trials of daraxonrasib, an oral
ZW191 demonstrates encouraging anti-tumor activity in heavily pretreated ovarian and endometrial cancers, regardless of FRα expression Confirmed objective response rate (cORR) of 61% at doses 6.4-9.6 mg/kg in platinum resistant ovarian cancer Median duration of response was not reached at the time
MELBOURNE, Australia and INDIANAPOLIS, April 22, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that safety and tolerability data from the ProstACT Global Phase 3 study (Part 1) will be presented as a late-breaking oral presentation at the
Clinically meaningful efficacy demonstrated in the 8-week follow-up period (weeks 9-16), with a 90% median reduction in clinical seizures over baseline in weeks 9-12 and a 59% median reduction in clinical seizures over baseline in weeks 13-16 New data demonstrate that RAP-219 has a half-life of
– Data from Four Studies Spotlight Rising Clinical Interest & Urgency to Address Cisplatin-Induced Hearing Loss and Its Lasting Impact on Patients – RESEARCH TRIANGLE PARK, N.C., April 21, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical
Rapid oral presentation of PD-L1 subgroup data from HERIZON-GEA-01 evaluating zanidatamab combinations, and additional analyses of tolerability, biomarker response and real-world treatment patterns in HER2+ GEA For U.S. media and investors only DUBLIN, April 21, 2026 /PRNewswire/ -- Jazz
SAN FRANCISCO, April 21, 2026 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced it
Phase III METEOROID study met its primary endpoint in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) MOGAD is a rare autoimmune disease of the central nervous system characterised by unpredictable attacks of the optic nerves, spinal cord or brain that are often severe and debilitating Data will be submitted to...
REDWOOD CITY, Calif., April 21, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that detailed results from the global, randomized Phase 3 RASolute 302
CAMBRIDGE, England & BOSTON --(BUSINESS WIRE)--Apr. 21, 2026-- Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ®) technology, today announced an oral presentation and
As published in The Lancet and presented at AAN, NIMBLE trial met its primary and key secondary endpoints at week 24, demonstrating potential best-in-class efficacy and convenience in gMG U.S. regulatory application submitted; cemdisiran could be the first siRNA to be approved for the treatment
Results from Part 1 of the Phase 1b MUIR trial to be presented at annual meeting in June SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) -- Zentalis ® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor
Houston, Texas and Tuebingen, Germany, April 21, 2026 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, today announced all submitted abstracts have been
DOYLESTOWN, Pa., April 21, 2026 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, today announced
Poster to be presented at the American Society for Clinical Oncology on Monday, June 1, 2026 BELTSVILLE, Md., April 21, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class
WATERTOWN, Mass., April 21, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced that it will
SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced it will present updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial
- Data from pivotal frontMIND study of tafasitamab (Monjuvi®/Minjuvi®) in first-line diffuse large b-cell lymphoma (DLBCL) featured in oral presentation at ASCO; results support global regulatory submissions WILMINGTON, Del. --(BUSINESS WIRE)--Apr. 21, 2026-- Incyte (Nasdaq:INCY) today announced
Expansion Adds to Growing Global Trial Footprint Patient Screening and Enrollment Expected to Begin in Q2 2026 SOUTH SAN FRANCISCO, Calif., April 21, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic
WALTHAM, Mass. and BOULDER, Colo., April 21, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the results from the Phase 3 PEAK trial have been selected for
Two oral presentations including late-breaker at SID Data will cover Phase 1 clinical trial of soquelitinib for atopic dermatitis, including new immunologic and biomarker data supporting drug-free remissions Investor and analyst meeting scheduled for 1:30 pm ET ( 12:30 pm CT) on May 14, 2026
120 mg and newly announced 60 mg once-daily doses each achieved ≥85% median hsCRP reductions in participants with obesity and elevated baseline inflammation BGE-102 was well tolerated across all dose levels Phase 2 proof-of-concept trial in cardiovascular risk planned to initiate mid-2026, with
This is the first release of 36-week symptom response & tissue health data for the highest dose (Cohort 9) from the dose escalation portion of Eupraxia’s RESOLVE trial. At 36 weeks, patients in Cohort 9 (n=3) demonstrated a robust response in both tissue health and symptom response compared to
Oral presentation will include previously announced topline results as well as pre-specified and post-hoc data updates REDWOOD CITY, Calif., April 21, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nas...
– New data highlight potential treatment benefit across multiple AxD symptom domains, reinforcing zilganersen’s positive impact on people living with this rare, often fatal neurological disease – – PDUFA date set for September 22, 2026 – CARLSBAD, Calif. --(BUSINESS WIRE)--Apr.
21 April 2026 Ultomiris demonstrated statistically significant and clinically meaningful reduction of proteinuria in adults with immunoglobulin A nephropathy in I CAN Phase III trial Ultomiris delivered rapid reduction in proteinuria as early as week 10 Results show potential for terminal C5 complement inhibition with Ultomiris as a disease-modifying...
100% of patients achieved rapid, sustained improvements across MG-ADL and QMG at 24 weeks, further increasing confidence in Phase 3 trial Totality of efficacy and safety data reinforces miv-cel’s differentiated and potential best-in-class profile for delivering durable, drug-free, disease-free
James Treat, MD, Professor of Clinical Pediatrics and Dermatology at the Children’s Hospital of Philadelphia to present clinical results on Wednesday, May 20, 2026, at 4:30 p.m. ET WAYNE, Pa., April 20, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc.
29% and 31% of patients in the 18 µg/kg and 24 µg/kg extension arms, respectively, achieved new SALT Score ≤20 from week 36 to week 52 with continued twice-monthly treatment Increasing proportions of patients achieved clinically meaningful hair growth thresholds across numerous SALT measurements
Phase 1 combination data of 6.5mg/m 2 Q2W nuzefatide pevedotin plus nivolumab demonstrate an encouraging preliminary efficacy profile with a differentiated tolerability profile in previously treated metastatic urothelial cancer Nuzefatide pevedotin demonstrates potent preclinical anti-tumor
ZUG, Switzerland, April 20, 2026 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and
Last patient visits for both OCS-01 Phase 3 DIAMOND trials (total 800+ patients) are complete, with topline results expected in June 2026 A non-invasive topical treatment for diabetic macular edema (DME) has the potential to address significant unmet needs for early treatment intervention and for
20 April 2026 Tozorakimab met primary endpoint in Phase III MIRANDA trial in patients with COPD Third positive pivotal Phase III clinical trial of AstraZeneca's IL-33-targeting biologic further demonstrates its benefits in COPD Positive high-level results from the pivotal Phase III MIRANDA trial showed potential first-in-class tozorakimab demonstrated a...
WILMETTE, Ill., April 19, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, announced new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC) showing...
Azetukalner data show significant reductions in seizure frequency across weekly, monthly and multi-year time points X-TOLE2 data featured in Late-breaking Science session show 53.2% reduction in monthly seizure frequency in 25 mg group vs. 10.4% for placebo and increasing rates of 100% seizure
REDWOOD CITY, Calif., April 19, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced updated Phase 1 (RMC-9805-001) clinical data for zoldonrasib, an oral
SAN FRANCISCO, April 19, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today announced it will host an investor call and live webcast to review 52-week topline results from the 16-week extension
ADAPT OCULUS is the first study to evaluate a targeted treatment for ocular MG, demonstrating that VYVGART significantly improves disease symptoms in this underserved patient population ADAPT SERON, OCULUS, and Jr study results build on VYVGART's approved gMG indication and show its potential as
Triple combination of muzastotug + atezolizumab + bevacizumab resulted in much higher overall response rates (ORR) compared to the atezolizumab + bevacizumab control arm (66.7% vs. 32.5%, respectively by Investigator per HCC-specific Modified RECIST v1.1) as 1L therapy in a Phase 1b/2 trial in
New phase 2 data from personalized cancer vaccine EVX-01 demonstrates a record-high rate of vaccine targets triggering a tumor-specific immune response The results reinforce that Evaxion’s pioneering AI platform, AI-Immunology™ accurately identifies and selects the most relevant vaccine targets
Zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, showed a 53.7% confirmed intracranial objective response rate (iORR) for small cell lung cancer (SCLC) with brain metastases; at 1.6 mg/kg dose, the confirmed iORR was 62.5% (10/16), including complete responses Encouraging
Individual experimental treatment attempt at Hopp Children’s Cancer Center Heidelberg (KiTZ) and Heidelberg University Hospital (UKHD) using a TCR T-cell therapy engineered with a PRAME-directed TCR provided by Immatics 17-year-old adolescent with bulky, rapidly progressing nephroblastoma and no
Data analysis conducted in collaboration with a leading academic medical center shows that AI ‑ Immunology™ enables vaccine design also for the deadly brain cancer, glioblastoma Uniquely, the platform can identify a novel source of targets to include in glioblastoma cancer vaccines, potentially
Six poster presentations showcase Zymeworks’ next-generation ADC programs, including multiple first-in-class pan-RAS inhibitor ADCs Data highlight efficacy, tumor-selective delivery, and favorable tolerability across multiple solid tumor models New programs include Ly6E, CLDN18.2, and
First study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in gastroesophageal cancer shows disease control rate (DCR) in 77% of patients and long-term survival beyond 20 months in a subset of patients Induction strategy linked to improvement in PFS (HR 0.19; p=0,015) and survival rates at
Oral presentation highlights additional data from PROGRESS Phase 2b study of pilavapadin supporting selection of 10mg as optimal dose for Phase 3 development in DPNP New data on spasticity further validates the broader potential importance of the AAK1 pathway in neurologic diseases THE WOODLANDS,
WALTHAM, Mass., April 17, 2026 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today announced two upcoming poster presentations at the American Thoracic Society
Data from subset analysis of cabozantinib-pretreated patients support potential to overcome resistance and resensitize tumors to VEGF TKI therapy 44% ORR and 94% DCR in ccRCC patients previously treated with cabozantinib, with tumor shrinkage observed in 75% of patients Responses observed in
Poster presentation scheduled for Tuesday, May 5th at 12:30 PM CDT Denver, CO, April 16, 2026 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation, once-daily, oral PDE4 inhibitor prodrugs designed for targeted delivery to the terminal ileum and colon, today...
PLYMOUTH MEETING, Pa. --(BUSINESS WIRE)--Apr. 16, 2026-- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will present encore open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment
— Alixorexton Data From Seven-Week Open-Label Extension Period Demonstrated Sustained Improvements in Patient-Reported Disease Severity, Cognitive Functioning and Fatigue— — Alixorexton Was Generally Well Tolerated at All Doses Tested — — Phase 3 Brilliance NT1 Study of Alixorexton in Patients With