WATERTOWN, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases, today announced that the Company granted non-statutory stock options to new
CAMBRIDGE, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a biopharmaceutical company leveraging a novel Oligonucleotide Promoted Editing of RNA (OPERA ®) platform to develop a new class of genetic medicines for rare and highly prevalent diseases, today announced
EMERYVILLE, Calif., Aug. 14, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to
ZUG, Switzerland, Aug. 14, 2026 (GLOBE NEWSWIRE) -- The attached notifications relate to the vesting and settlement of RSUs previously granted to directors of the Company. Attachments Notification of managers' transaction - Anthony Rosenberg - 13 August 2026 RSU vest Notification of managers'
MIRAMAR, Fla., Aug. 14, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia,
Exploratory analyses of patients with very severe social anxiety disorder demonstrated nominally statistically significant improvement in recently reported clinical studies FDA engagement planned during the current quarter regarding potential future Phase 3 path forward for fasedienol in social
Clene expects to submit a New Drug Application for CNM-Au8® in ALS under the accelerated approval pathway in early fourth quarter of 2026 Clene announces survival and functional benefit in CNM-Au8-treated patients whose NfL declined or stabilized SALT LAKE CITY, Aug.
– Receives FDA Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome – Reports Positive Clinical Update from Ongoing Pediatric Compassionate Use Program in Netherton Syndrome – Receives U.S. Notice of Allowance for a Patent Covering a Combination Treatment for
Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial completed Rezatapopt NDA submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash
COPENHAGEN, Denmark, August 14, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its second quarter 2026 financial results on Thursday August 20, 2026,
TUDRIQEV™ in combination with nivolumab receives FDA accelerated approval and will launch within 60 days Michelle DiNapoli appointed as Chief Commercial Officer Recently completed financing extends cash runway to support commercial launch and confirmatory trial WOBURN, Mass., Aug.
BEDFORD, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced U.S.
- Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization - - Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”); topline
- Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization - - Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder (“MDD”); topline
Favorable pre-clinical data reported for NMRA-215 with plan to submit IND in fourth quarter of 2026 and initiate Phase 1 study by end of 2026 Progressing NMRA-511 in Alzheimer’s disease (AD) agitation and NMRA-898 in schizophrenia with clinical data expected in fourth quarter of 2026 and second
First patient dosed in an outpatient setting, discharged the same day; multiple patients in the process of screening at several activated sites Trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and
NEW YORK & LYON, France, August 14, 2026 Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, the companies’ 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin...
ROCKVILLE, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a global biotechnology company that identifies differentiated innovation and applies disciplined development, financing, and partnering strategies to create value, today announced
Executed a development collaboration with Senlang Biotechnology to advance certain in vivo CAR-T product candidates, including TPST-4003, a CD7-targeted next-generation in vivo CAR-T, with first patient dosing anticipated in the fourth quarter of 2026 and initial clinical data expected in the first
-- Topline data from Phase 3 OnPrime/GOG-3076 ovarian cancer registrational trial of Olvi-Vec expected in 2H26 -- -- Olvi-Vec systemic development programs continue to advance, with additional dose-escalation updates anticipated in 2026 -- -- Recently published Phase 1b/2 VIRO-15 translational
AKTX-101 advancing through IND-enabling development activities toward planned initiation of Phase 1 clinical trial in mid-2027 Compelling ASCO 2026 preclinical data further differentiates PH1 mechanism in KRAS-mutated pancreatic cancer models Strategic research collaboration with Whitehawk
SAN FRANCISCO, Aug. 13, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today reported financial results for the second quarter ended June 30, 2026. Cash and investments in marketable securities
REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer on July 14, 2026; on track for commercial launch late third quarter 2026 NCCN® Clinical Practice Guidelines recommended REVTORPYK in combination with
-- ANTLER phase 1 data presented at EHA 2026 reinforce vispa-cel safety, efficacy, and durability are on par with approved autologous CAR-T cell therapies and that vispa-cel has the potential to overcome access barriers for patients with 2L LBCL -- -- CaMMouflage dose escalation phase 1 data
Completed enrollment for 4D-150 4FRONT-2 wet AMD Phase 3; topline data expected in H2 2027 4D-150 4FRONT-1 Phase 3 topline data expected in Q2 2027 Presented positive 2-year data from 4D-150 PRISM Phase 2b at ASRS, highlighting long-term continuous treatment effect and ongoing favorable safety
BEDFORD, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular” or the “Company”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it has granted inducement awards to Ms.
Achieved Q2 2026 PEMGARDA ® (pemivibart) net product revenue of $14.3 million, representing 21% growth versus Q2 2025 net product revenue of $11.8 million Completed rapid enrollment in VYD2311 DECLARATION clinical trial expansion cohort and LIBERTY clinical trial, driven by strong subject demand
Announced sale of manufacturing operations ( July 2026) for $122.5 million and transition to fully outsourced model with leaner, approximately 140-person workforce focused on novel therapeutics pipeline Data presentations at ESMO planned for MGC026 (B7-H3 ADC) and lorigerlimab (PD-1 × CTLA-4)
Record revenue, with Q2 2026 product sales of $37.6 million, representing 99% growth over Q2 2025 Q2 2026 fully diluted GAAP EPS of $0.35, non-GAAP fully diluted EPS of $0.43; EBITDA of $14.1 million, Adjusted EBITDA of $16.2 million Raising full year revenue guidance, with 2026 revenue now
Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC), continues enrolling with interim analysis on track for 4Q 2026 Phase 3 protocol of roxadustat for the treatment of anemia in
$26.2 million in U.S. neffy ® net product revenue in Q2 2026; total U.S. epinephrine market share for Type 1 allergies of 5% and 8% share within field-targeted accounts Commercial investment realigned toward targeted provider engagement, significantly reducing total operating expenses for 2H 2026
Final Data from Phase 2 Expansion Study of NUC-7738 Remains on Track for 2026 Advancing Additional Indications and Combination Strategies for NUC-7738 Cash Runway Expected to Extend into 2029 EDINBURGH, United Kingdom, Aug. 13, 2026 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) (“NuCana” or the
– ONWARD3: 54% of patients reached complete skin clearance (PASI 100) at 48 weeks, positioning envudeucitinib to set a new standard in PsO – – Alumis remains on track to submit its New Drug Application to FDA for envudeucitinib in moderate-to-severe plaque psoriasis (PsO) in Q4 2026 – – Potentially
Announced positive blinded six-month interim safety and biomarker results from PRECISE-AD, the Company's Phase 1b trial of PMN310 in patients with early Alzheimer's disease (AD), including zero cases of amyloid-related imaging abnormalities-edema (ARIA-E) across all participants and genotypes, including APOE4 homozygotes....
PALO ALTO, Calif., Aug. 13, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the second quarter ended June 30, 2026. "Kodiak continues to execute broadly across our late-stage clinical portfolio as we approach three Phase 3
KELOWNA, BC / ACCESS Newswire / August 13, 2026 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the “ Company ” or “ Lexaria “), a global innovator in drug delivery platforms, announces that it has entered into a Material Transfer Agreement (“ MTA “) with Pegbio Co., Ltd (“ PegBio “) to investigate Lexaria’s DehydraTECH technology with a proprietary PegBio...
WOBURN, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the quarter ended...
Cash and Cash Equivalents of $28.4 Million as of June 30, 2026 Providing Runway Through Mid-2027; Company Advances Chemistry, Manufacturing and Controls (CMC) Work Toward NDA Resubmission KANSAS CITY, Kan., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc.
First lupus nephritis patient dosed in RECLAIM-LN, a Phase 2 potentially registrational trial utilizing FT819, an iPSC-derived, off-the-shelf CAR T-cell therapy; patient was treated as an outpatient with same-day discharge FDA clearance of the FT839 IND application advances the Company’s novel
Planning to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene) in localized, intermediate- to high-risk prostate cancer in Q4 2026 Pivotal phase 3 clinical data published in The Lancet Oncology demonstrated a statistically significant improvement in
ROCKVILLE, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel,
The number of patients experiencing moderate to severe odynophagia (pain swallowing) in the cohorts analyzed (Cohorts 7-9) was reduced from 62% at baseline to 25% from 24 through to 52 weeks post treatment In the same analysis, 23% of patients reported severe odynophagia at baseline; and no
– Q2 2026 product revenue of €315 million (+105% Y/Y), comprising €252 million for YORVIPATH ®, €55 million for SKYTROFA ®, and €8 million for YUVIWEL ® – Through July 31, more than 220 unique YUVIWEL patient enrollments in the U.S. – Substantial pipeline updates: presented long-term Phase 2 & 3
First patients treated in randomized Phase 2 trial C-1300-02 were alive at Day 28, with improved oxygenation, resolution of ARDS with return to spontaneous breathing and liberation from vasopressor support Clinical recovery and biologic readouts moved in the same direction; serum and
SAN FRANCISCO, Aug. 13, 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 the
- Obexelimab BLA submission for the treatment of IgG4-RD accepted by FDA; PDUFA target action date of May 27, 2027 - - New study data confirm bioequivalence of obexelimab single-dose prefilled autoinjector pen compared to prefilled syringes - - Obexelimab global Phase 2 SunStone SLE trial topline
EscharEx ® Phase III VALUE Trial Advancing; Interim Assessment and Enrollment Completion Expected by End of First Quarter 2027 Master Services Agreement Signed with Vericel Under its BARDA Contract for NexoBrid ® Second Quarter Revenue of $3.1 Million; Full-Year 2026 Revenue Guidance of $24–26
Updated data from the MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC on track to be reported in Fall 2026; update to include detailed analyses of patients treated at or below a dose cap Updated data from the MICVO Phase 1/2 combination study with pembrolizumab in 1L R/M HNSCC on track to be
• Initiated Study to Assess the Potential Impact of the Combination of Icovamenib and Low-Dose Semaglutide on Physical Function, Body Weight, Body Composition, Muscle Health, and Metabolic Outcomes SAN CARLOS, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc.
First clinical validation of Axiomer™ RNA editing established through NTCP modulation with positive AX-0810 clinical target engagement data; full Phase 1 dataset to be presented at a medical or scientific conference later this year Multiple clinical milestones, including initial AX-0811 Phase 1 data expected by year-end 2026, followed in H1 2027 by:...
Phase 3 clinical trial of denifanstat in moderate to severe acne patients in the U.S. on track to initiate in second half of 2026 FOSTER CITY, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics
Total product sales of €64.0 million In-line with expectations; full-year guidance of €135 -150 million reaffirmed Solid cash position of €121.5 million as of end June 2026 Reflects disciplined cash management and proceeds from the recent reserved offering [1] Restructuring program implemented with positive P&L and cash flow impacts expected in the second...
U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) with Priority Review for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027 Company presented additional positive secondary
PRINCETON, New Jersey, TOKYO, Japan, CAMBRIDGE, Mass., August 12, 2026 — Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib and
BRANFORD, Conn., Aug. 12, 2026 /PRNewswire/ -- Azitra, Inc. (" Azitra " or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, today reported financial
- Executed a $15.3 million financing with milestone warrants providing potential for an additional $34.0 million in gross proceeds, supporting continued advancement of ABP-450's development program - Upfront proceeds from financing provide cash runway into the first quarter of 2027 ALISO VIEJO,
NEW YORK, NY, August 12, 2026 — Royalty Pharma plc (Nasdaq: RPRX) today announced an agreement for $100 million in funding to Zealand Pharma in exchange for Zealand Pharma’s economics related to rusfertide (PTG-300), a potential first-in-class therapy for polycythemia vera, a rare and chronic blood disorder....
– Completed enrollment in Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD – – Expect to report topline results from both Phase 2 Seabreeze STAT studies in September 2026 – – Cash runway expected for a period of at least one year from the date of this release – SAN DIEGO,
Phase 3 C-BEYOND Trial Met Primary and Secondary Endpoints, with a Short 8-week Duration for Patients Without Cirrhosis Supporting a Potential Best-in-Class Profile of BEM/RZR for Treatment of HCV C-FORWARD Phase 3 Trial Outside North America on Track with Topline Results Expected Early Q1 2027
Pivotal Phase 2 ALPHA3 Program in 1L Large B-cell Lymphoma (LBCL): Recent Interim Futility Analysis Supports Cemacabtagene Ansegedleucel’s (Cema-Cel) Potential as an Outpatient, MRD-Guided 1L Consolidation Therapy Strong Execution and Increased Investigator Interest Accelerated 2026 Site
– KOMZIFTI ® (ziftomenib) generated $9.1 million in net product revenue, up 57% over 1Q, and approximately 115 new patient starts, up 35% over 1Q – – KOMZIFTI ® achieved majority share of new patient starts in R/R NPM1-m AML menin inhibitor class, establishing leadership after just two full
Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected 2H 2026 ARR-217, a CDH17 targeted ADC for gastrointestinal malignancies, advanced to Phase 1b dose optimization Dosing of first patient with ARR-002, a dual-targeting MUC16/NaPi2b
Sangamo Therapeutics, Inc. (OTCID Basic Market: SGMOQ), a genomic medicine company, today announced that it has successfully concluded a court-supervised auction process under Section 363 of the U.S. Bankruptcy Code to maximize the value of Sangamo’s assets for the benefit of all stakeholders.
Genmab A/S has published its Articles of Association dated August 11, 2026. The Articles of Association can be found on Genmab’s website: https://ir.genmab.com/genmab-news Contact: Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
WILMETTE, Ill., Aug. 12, 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 second quarter 2026 financial results and provided business updates....
Biologics License Application (BLA) for TA-ERT for the Treatment of MPS IIIB Anticipated in the Fourth Quarter of 2026 TrAnsform Confirmatory Study Required for Potential FDA Accelerated Approval of TA-ERT Expected to Initiate in the Fourth Quarter of 2026 Strengthened Leadership Team with the
Article by CEO Thomas K. Equels calls for proactive evaluation of broad-spectrum antiviral countermeasures before novel viral threats emerge Highlights Company’s investigational drug Ampligen® (rintatolimod) and its potential application as a broad-spectrum prophylactic or early-onset antiviral countermeasure in Ebola and its variants Access the article...
Enrollment in the ongoing Phase 1 dose escalation ACESOT-1051 trial of oral WEE1 inhibitor APR-1051 is accelerating as dose escalation advances Aprea plans to advance APR-1051 in uterine serous carcinoma (USC), and Cyclin E–overexpressing platinum-resistant ovarian cancer (PROC) while also
Company to request a Type B meeting with the FDA to align on a registrational path in a setting with no approved targeted therapy — Study met its primary endpoint: six-month progression-free survival of 48.9% versus a pre-specified 20% benchmark for standard of care (p = 0.0047) — Median overall
Investment Broadens Patient Access to Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for Sanfilippo Syndrome Type B in the TA-ERT Expanded Access Program (EAP) TA-ERT EAP Expected to Initiate in the Fourth Quarter of 2026 SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--Aug.
Received FDA clearance of IND application for XTX501, a potential best-in-class bispecific PD-1 / masked IL-2 Advancing IND-enabling studies for potential first-in-class multi-specific, masked T cell engager programs targeting CLDN18.2 and PSMA+STEAP1; IND applications anticipated in the second
FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals; $30 Million in Upfront and Near-Term Milestones Achieved
Randomized Phase 2 trial in microsatellite stable colorectal cancer (MSS CRC) ongoing, with results expected in 1H 2027; potential registration trial expected in 2027 once recommended dose regimen has been established Data reported at AACR from triple combination therapy in 1L hepatocellular
Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash, cash equivalents and investments as of June 30, 2026 Webcast to be held today at 8:30 a.m.
Finalized SUNRISE-FA 2 open-label, pivotal trial protocol and SAP for LX2006 in support of accelerated approval pathway; topline data expected in second half of 2027 Initiated SUNRISE-FA 2 with first patient enrolled into pivotal study in June; site activation efforts ongoing CLARITY-FA enrollment
Expect to report topline results for ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer’s disease, in late 2026 Two candidates nominated for development in Acumen’s Enhanced Brain Delivery™ (EBD™) program; lead clinical candidate IND filing for the
First patient dosed in Phase 3 ALLOHA-2™ study; topline readout expected mid-2028 Shared positive initial data from Cohort C of Phase 1 ALLOHA™ study, validating internal commercial-ready manufacturing process Cash and cash equivalents fund operations into the second quarter of 2027 WALTHAM, Mass.,
– Breakthrough results from V012 dialysis access Phase 3 study, where ATEV was observed to outperform AV fistula; supplemental Biologic License Application (sBLA) for dialysis access to be filed with the Food and Drug Administration ( FDA) during the second half of 2026 – – FDA accepted IND for
Topline data from CHAPTER-3, a pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks, expected in 3Q2026 Deucrictibant IR NDA under review by the FDA with PDUFA date of April 23, 2027; MAA validated by the EMA in July 2026 Enrollment ongoing in CREAATE, a pivotal study of
Rapid, Positive Clinical Outcomes in GBS FORWARD Study Reinforce Consistency and Reproducibility of Tanruprubart Treatment Effect Demonstrated in Phase 3 and Real-World Evidence Studies; BLA Submission Expected in Q4 2026 Vonaprument Phase 3 GA Program Expanded with Month 15 / 24 Dual Primary
BRISBANE, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies for multiple neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced the addition of a
Files six new lawsuits as company escalates fight to protect patients INDIANAPOLIS, Aug. 12, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today escalated its continued fight to protect patients from the dangerous black market for retatrutide, filing six new lawsuits against U.S.
New data presented at Digestive Disease Week (DDW) demonstrating improvement of fibrosis and inflammation following a single treatment of EP-104GI Strengthened executive team and board to bolster late-stage drug development and global commercialization capabilities.
Positive Phase 2 CRDF-004 data presented in an oral session at ASCO support advancement of 30 mg onvansertib plus FOLFIRI/bevacizumab into planned registrational program for first-line RAS-mutated mCRC Following successful End-of-Phase 2 meeting with FDA, Company aligned on key elements of
Announced positive interim Phase 1 data from the HEADLINE™ trial of ABS-201 Completed $100 million underwritten offering, including $40 million strategic investment from Eli Lilly & Company Cash, cash equivalents, and marketable securities now sufficient to fund operations into the second half of
First-in-class immune-stimulating antibody conjugate BDC-4182 Phase 1/2 study ongoing, initial clinical data expected to be released with Bolt's 3Q 2026 results Cash balance of $18.1 million as of June 30, 2026 anticipated to fund operations into 1Q 2027 REDWOOD CITY, Calif., Aug.
ROCKVILLE, MD, Aug. 11, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced that Gilead Sciences, Inc.
FDA grants RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS) based on compelling clinical data, further expanding the therapy’s potential across neuroimmunology On track to complete rolling BLA submission for miv-cel in stiff person syndrome (SPS) in Q4
Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film Remains on track to resubmit Anaphylm NDA to the FDA in Q3 2026 Continues pre-launch medical affairs activities and payer engagement On track to begin ex-U.S.
Prescription Drug User Fee Act target action date is February 12, 2027 If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 SAN DIEGO, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio ® ” or the “Company”), a clinical-stage
Updated ERAS-0015 data in U.S. trial highlighted compelling monotherapy efficacy in 2L+ KRAS G12X PDAC and continued favorable tolerability, as well as further advancement of panitumumab CRC combination ERAS-0015 program advancing toward three potentially registration-enabling trials in pancreatic
Completed dosing in the REVEAL pivotal (N=17) and ASPIRE (N=4) trials evaluating TSHA-102 for Rett syndrome; expect to report topline data from 6 ‑ month interim analysis and FDA feedback on the BLA submission pathway in 1H 2027 TSHA-102 continues to be generally well tolerated with no severe
Expanding Phase 2 study start-up activities to support global trial of oral epetraborole in polycythemia vera Enrollment ongoing in Phase 2 investigator-initiated trial of epetraborole for M. abscessus lung disease Positive non-human primate efficacy and favorable Phase 1 clinical pharmacokinetics
Company Announcement COPENHAGEN, Denmark; August 11, 2026 – Genmab A/S (Nasdaq: GMAB) will increase its share capital by 24,592 shares as a consequence of the exercise of employee warrants. The increase is effected without any preemption rights for the existing shareholders of the Company or
JERUSALEM, Aug. 10, 2026 /PRNewswire/ Scinai Immunotherapeutics Ltd. (NASDAQ: SC NI ) ("Scinai" or t he "Company" ), a biopharmaceutical company advancing a pipeline of innovative inflammation and immunology therapeutics, today announced that its wholly owned subsidiary, Scinai Biopharma Services Ltd ....
Enrollment on track for Phase 3 UPSTREAM MG trial of telitacicept in generalized myasthenia gravis patients with topline results anticipated in 1H27 Enrollment ongoing for Phase 3 UPSTREAM SjD of telitacicept in primary Sjögren’s disease Pro-forma cash and investment balance of $514.5 million
Findings further validate Cingulate’s Precision Timed Release™ (PTR™) platform and its trimodal drug delivery approach KANSAS CITY, Kan., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company advancing next-generation pharmaceutical products through its
Patient dosing is ongoing in the Phase 1b/2 study of TH103; preliminary data anticipated in 1H 2027 Potential Phase 3 clinical trials remain on track for initiation by year-end 2027 $93.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 is expected to fund operations
Expect to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in 4Q 2026 The ADVANCED-3 trial is being redesigned as an exploratory trial to expand into and accelerate data in high-grade, high-risk BCG-Naïve and BCG-Exposed CIS (± Ta/T1) patients and papillary
TibuSHIELD enrollment complete, exceeding initial enrollment target with 247 participants randomized in HS; topline data expected Q4 2026 TibuSURE enrollment complete, exceeding initial enrollment target with 91 participants randomized in SSc; topline data expected H1 2027 Zura plans to initiate a
Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. on track to initiate in second half of 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Secured equity financing with gross proceeds of $175.0 million in April 2026 Cash, cash
Data from Phase 1/2 trial of NGN-401 for Rett syndrome showed 100% of participants improved in CGI-I score and gained ≥1 developmental milestone, with an average of 4.7 milestones per participant; no plateau and no milestone loss observed as of data cutoff date of June 16, 2026 Milestones gained in
Positive topline results from open-label Phase 2 Study ‘207’ evaluating VDPHL01 in female pattern hair loss demonstrated rapid onset and consistent hair growth Completion of patient enrollment for Phase 2/3 Study ‘306’, a 556 participant, registration-directed trial evaluating VDPHL01 in female
~ 2026 Second Quarter Net Product Sales of $17.1 Million, Up 78% Year over Year ~ ~ 2026 Second Quarter Non-GAAP Adjusted EBITDA of $2.8 Million ~ ~ Record PEDMARK ® Demand Carried into Third Quarter 2026 as Field Sales Expansion Efforts Continue to Validate Commercial Growth Strategy ~ ~
– Company rapidly advancing toward Q1 2027 initiation of Phase 3 trials designed to deliver best-in-class efficacy with convenient quarterly dosing in both severe asthma and CRSwNP; End-of-Phase 2 interactions with FDA on track – – Completed enrollment in Phase 2 trial in COPD; data expected in the
Company reports AUCATZYL® (obecabtagene autoleucel; obe-cel) net product revenue of $45.7 million in Q2 2026, an increase of 119% year-over-year FY 2026 net product revenue guidance increased to $140 - $150 million Gross margin increased in Q2 2026, driven by growing volumes and cost reduction
Company continues to prepare for late-stage clinical advancement of vopimetostat in combination with daraxonrasib for pancreatic cancer following positive Phase 1/2 data Phase 1/2 data from combination study of vopimetostat + RAS(ON) inhibitors in pancreatic cancer to be presented at 2026 ESMO
PH-894 protection for chemical structure, genetic sequencing and broad application for proliferative and infectious diseases in U.S. King of Prussia, Pennsylvania--(Newsfile Corp. - August 11, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...
Phase 3 CoMpass trial fully enrolled with 108 patients, exceeding enrollment target; on track for topline data in 2H 2027 Strategic operating plan refined to focus on development of bel-sar in ocular oncology Interim NMIBC data reinforce bel-sar’s potential for durable efficacy and favorable safety
AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD) Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance Recent positive interim results showed safety and
– Leadership Team Expanded with Key Executive Appointments, Including Chief Executive Officer, Chief Medical Officer and Chair of the Board of Directors, to Support Clinical Development, as well as NDA and Commercial Readiness – – Pivotal Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis on Track, with Top-Line Data Expected by...
VANCOUVER, British Columbia, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that management will participate in
Phase 3 ALTO trial designed to demonstrate superiority of KSI-501 versus aflibercept in patients with diabetic macular edema PALO ALTO, Calif., Aug. 10, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina-focused biotechnology company committed to researching, developing
Enrollment continues across all indications in Ntrust-1 and Ntrust-2 at the 4 billion cell dose level (12 billion cells in 3-dose cycle) Initial clinical data from Ntrust-1 and Ntrust-2 expected to be presented at a medical conference in 2026 Cash balance of $243.2 million on June 30, 2026,
Advancing a potentially best-in-class once-daily oral, locally-activated PDE4 inhibitor prodrug specifically engineered for the treatment of inflammatory bowel disease (IBD) Enrollment of first patient for Phase 2 ASCENTRA-UC trial of PALI-2108 expected in the second half of 2026;...
– ONWARD3 data show 54% of patients reached complete skin clearance (PASI 100) after 48 weeks of continuous envudeucitinib treatment – – Favorable long - term safety and tolerability profile remained consistent with previously reported data – – On track to submit a New Drug Application to FDA in 4Q
Completed enrollment of patients contributing to the Phase 3 PROACT 1 accelerated approval efficacy analysis, positioning the Company for anticipated pivotal eGFR slope topline results in Q2 2027 On track for completion of full enrollment for PROACT 1 in the second half of 2026 Appointed Kenneth
One-year REMAIN-1 Midpoint Cohort data show Revita patients maintained up to 84% of prior GLP-1-induced weight loss versus 46% with sham in patients receiving complete duodenal ablations — the first randomized evidence of durable, drug-free weight maintenance One-year open-label REVEAL-1 Cohort
Over Four Decades of Clinical, Scientific and Corporate Leadership Advancing Innovation in Retinal Disease BRISBANE, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies for multiple
TRUTAKNA™ granted accelerated approval by U.S. Food and Drug Administration (FDA) in adult patients with primary IgA nephropathy (IgAN) at risk for disease progression. Alignment with FDA on earlier ORIGIN 3 final efficacy analysis to support potential full approval for TRUTAKNA in adults with
Continued progress toward starting SC451 Phase 1/2 trial, including GLP toxicology studies, SC451 process transfer to the contract manufacturer, and clinical trial readiness Continued progress toward starting clinical study for SG293 in non-Hodgkin lymphoma and generating initial clinical data,
– Appointment Strengthens Board with Financial, Capital Markets and Commercial Leadership Expertise as the Company Approaches Pivotal Phase 3 ENSURE Readout in Relapsing Multiple Sclerosis as well as Potential Regulatory Filings and Commercialization – NEW YORK, August 10, 2026 – Immunic , Inc. (Nasdaq:...
MINNEAPOLIS, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today reported financial results for the second quarter ended June 30, 2026.
– Initiated the Phase 1/1b CLARITY-101 clinical trial of DMR-001 in patients with mutant calreticulin (mutCALR)-driven essential thrombocythemia (ET) and myelofibrosis (MF) – – Presented DMR-001 preclinical data at the European Hematology Association (EHA) 2026 Congress, showcasing best-in-class
First extracellular protein degraders in the clinic demonstrate rapid and robust pharmacodynamic effects and compelling safety in nearly 200 individuals dosed, Phase 3 trial underway Positive clinical biomarker and patient data presented from Biohaven's extracellular degrader platform demonstrated
Completed enrollment in the pivotal Phase 3 OPERA-01 trial; top-line data are now expected in the first quarter of 2027 Presented initial Phase 1 clinical data for OP-3136 at the 2026 ASCO Annual Meeting Announced a clinical trial collaboration and supply agreement with Bayer to evaluate
Phase 1 Clinical Trial Ongoing for SEP-479, an Oral Small Molecule PTH1R Agonist SEP-479 Observed Clinical Pharmacokinetic Profile Supports Once-Daily Dosing; SAD / MAD Data Expected in Q1 2027 Cash Position of $516.5 Million Expected to Support Operating Plans at Least into 2029 SOUTH SAN
NEW YORK, Aug. 10, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (the “Company”) (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and T cell engagers for cancer and autoimmune diseases, today announced that the Compensation Committee of the
SAN DIEGO, Aug. 10, 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 pathway-driven cancers, today announced that, in connection with the
CEO Michael Halstead to participate in a fireside chat on Wednesday, August 12 at 12:00 p.m. EDT NEW YORK and TORONTO, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Helus Pharma™ (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds
CEO Michael Halstead to participate in a fireside chat on Wednesday, August 12 at 12:00 p.m. EDT NEW YORK and TORONTO, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Helus Pharma™ (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds
CALABASAS, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments for central nervous system cancers, today announced financial results for the second quarter
Dr. Kim will advise on international partnerships and global access initiatives through the newly formed Office of the Executive Chairman CULVER CITY, Calif. --(BUSINESS WIRE)--Aug. 10, 2026-- ImmunityBio, Inc. ( NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that Dr.
Completed Enrollment and Ampligen Dosing in Metastatic Pancreatic Cancer Phase 2 Trial, Positioning Company for Key Clinical Milestones Through Early 2027 Pancreatic Cancer Remains Strategic Priority as AIM Advances Toward Planned Phase 3 Development While Seeking Select Government-Funded Infectious Disease Initiatives in Ebola OCALA, Fla., Aug....
– Publication details the discovery and preclinical characterization of ziftomenib, including its potency, selectivity, and mechanism of action – – Findings demonstrate differentiated menin binding and activity against certain resistance-associated mutations, further supporting ziftomenib’s
Call to be held Wednesday, August 12, 2026 at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time CALABASAS, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel
CAMBRIDGE, Mass., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Wave Life Sciences, Inc. (NASDAQ: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health (“ Wave ” or “ Wave Life Sciences ”), today announced the completion of the
Patent strengthens global IP protection for novel treatment approach designed to prevent stress-induced psychiatric disorders before symptoms develop SARASOTA, FLA., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a managed A...
Survival benefit is concentrated in participants with NfL biomarker response: CNM-Au8 ® -treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controls Functional benefit concentrated in participants with NfL biomarker response: CNM-Au8-treated
On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30 Completed onboarding of expert cross-functional Cogent customer-facing team, including all
SPY772 program aims to deliver best-in-indication efficacy and convenience in Hidradenitis Suppurativa through dual inhibition of TL1A and IL-17A/F in a long-acting coformulation Phase 2 SKYLIGHT trial designed to provide clinical proof-of-concept for TL1A and IL-17A/F inhibition in Hidradenitis
BOSTON, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL) (“Replimune”), a commercial-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the pricing of an underwritten offering of 9,701,490 shares of its common stock at an
SAN DIEGO, Aug. 10, 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 pathway-driven cancers, today announced the appointment of Charles S.
Adds ABS-1230, a clinical-stage, potential first-in-class precision therapy for KCNT1+ epilepsy Leverages Jazz development expertise and commercial strength in rare and severe epilepsies Transaction includes $820 million upfront payment DUBLIN and SAN DIEGO, Aug.
EVERLAST-A Week 28 data expected at the end of 3Q 2026; 52-week data for all participants expected in December 2026 EVERLAST-B fully enrolled ahead of schedule, with Week 16 data now expected in 4Q 2026 Phase 3 program for ORKA-001 expected to begin in 1H 2027 ORCA-SURGE Week 16 data accelerated,
Human factors and clinical study results support planned resubmission of Anaphylm™ NDA in the third quarter of 2026 Self-administration pharmacokinetic (PK) results were comparable to clinician-administered PK results Revised packaging design reduced median time to open pouch from 17 seconds in the
SION-719 Phase 2a proof-of-concept trial did not achieve key activity endpoint of sweat chloride reduction when added to standard of care; Company is not advancing SION-719 as an add-on to standard of care Potential confounders in SION-719 Phase 2a trial are being evaluated to inform next steps for
Phase 3 IZAR-1 trial in bio-naïve patients met all clinical endpoints at Week 16 for 60 mg sonelokimab The primary endpoint of ACR50 was met with a high response of 42.1% for sonelokimab’s 60 mg with induction, and significant responses were observed across key secondary endpoints, including ACR20
AbbVie to acquire Apogee for $135.11 per share in cash for total equity value of approximately $10.9 billion, positioning differentiated immunology portfolio to reach more patients worldwide Positive 16-week Phase 2 APEX Part B induction dose optimization results support planned advancement of
TNX-103 did not meet statistical significance on the primary endpoint of improvement in 6-minute walk distance versus placebo In prespecified exploratory analyses in the overall trial population, treatment with TNX-103 resulted in a 49% greater reduction in NT-proBNP compared to placebo (nominal
Additional financing from a world-class investor syndicate further strengthens the combined company's balance sheet to accelerate development of AVR-001 Private placement and the previously announced concurrent private placement are expected to fully fund Avere's operating plan into 2029 SAN
Total 2Q 2026 net product revenue of $218.4 million, representing 46% year-over-year growth AUVELITY ® 2Q 2026 net product sales of $180.3 million, representing 51% year-over-year growth SUNOSI ® 2Q 2026 net product revenue of $35.8 million, representing 20% year-over-year growth SYMBRAVO ® 2Q 2026
Clinical collaboration enables novel combinations of select BeOne oncology assets with four Revolution Medicines clinical-stage RAS(ON) inhibitors for RAS-addicted cancers Regional rights agreement provides BeOne with exclusive development and commercialization rights to four Revolution Medicines
Transaction will enhance Oculis’ strategic flexibility and ownership of Privosegtor while driving long-term value creation Transaction consideration includes $3.8 million up-front cash payment at closing and up to 2,050,000 Oculis ordinary shares subject to lockup release over a period of up to 2
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Aug. 07, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that on August 3, 2026 (the “Grant Date”),
WILMINGTON, Del. --(BUSINESS WIRE)--Aug. 7, 2026-- Incyte Corporation (Nasdaq: INCY) announced today that it granted restricted stock unit awards (RSUs) representing an aggregate of 21,556 shares of the Company’s common stock and stock option awards to purchase an aggregate of 18,172 shares of the
WALTHAM, Mass., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the “Company” or “Spyre”), a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater
BRISBANE, Calif., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that, on August 3, 2026, the Compensation Committee of the Board of Directors (Compensation Committee) of Vera Therapeutics granted inducement awards consisting of non-qualified stock options
BEDFORD, Mass., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular” or the “Company”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it has granted inducement equity awards to eight newly hired
U.S. Food and Drug Administration (FDA) Alignment on 12-Month Registrational Phase 3 Study to Support NDA for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis Oversubscribed $275 Million Private Placement Led by BVF Partners L.P.
LONDON, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that management will participate in a fireside chat at the Canaccord Genuity 46 th Annual Growth Conference on Wednesday, August 12, 2026 at 9:00 a.m. Eastern Time.
Conference Call 8:30 a.m. ET, Monday, August 10, 2026 MIAMI, Aug. 07, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a conference call and Q&A session on Monday,
Company awaiting comments from FDA by the end of August 2026 on protocol submitted for planned Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis. Workforce reduction of approximately 60% and program prioritization conserves capital and aligns resources on efzofitimod program in
WESTLAKE VILLAGE, Calif., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the grant of an aggregate of 143,500 restricted stock units
ASHBURN, Va., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that it plans to provide a corporate update and release its financial
BRISBANE, Calif., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced the granting of inducement awards on August 4, 2026 to five new employees
DALLAS, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today
DURHAM, N.C., Aug. 07, 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 the Company will release its financial results for the three
SAN DIEGO, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the “Company”) (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that on August 3, 2026, the Compensation Committee of the Company’s
FDA identified no major deficiencies related to the ketamine drug product, ingredients, proposed labeling, CMC, or other drug-related review matters. Remaining item relates to manufacturer certification for a luer lock vial already used in three FDA-approved ANDA products with 11.9 million units
Q2 2026 revenue of $29.1 million; GAAP basic EPS: $(0.12) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-induced liver fibrosis accepted by China’s CDE in May 2026 SAN DIEGO, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc.
BOSTON, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that Dr. Barbara Weber, the Executive Chairman of the Board of
Lead program now in Phase 1 development CAMBRIDGE, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the completion of the acquisition of RayThera Inc., a privately held biotechnology company focused on discovering and developing small-molecule therapies in
WAYNE, Pa., Aug. 06, 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 the U.S. Food and Drug Administration (the "FDA") has granted
Lasme-cel: Pivotal Phase 2 in r/r B-ALL (BALLI-01) FDA RMAT designation received for lasme-cel Full Phase 1 clinical data from the BALLI-01 trial presented at EHA 2026 Pivotal Phase 2 first interim analysis expected in Q4 2026 Eti-cel:...
Varsetatug masetecan (“Varseta-M”) Program: - Phase 1 monotherapy update in advanced colorectal cancer (CRC) expected by the end of 2026. Registrational study planned for initiation in 1H 2027 - - Phase 1 study in combination with bevacizumab in 3L+ mCRC ongoing.
- Duchenne (SGT-003): SGT-003 has been generally well tolerated in the Phase 1/2 INSPIRE DUCHENNE clinical trial, with 53 participants dosed as of August 4, 2026 - - Solid expects to meet with the FDA in late Q4 2026 to discuss the SGT-003 data package and to seek guidance on a potential
PiNACLE pivotal clinical trial evaluating ronde-cel in 3L+ patients with LBCL on track to report additional data in second half of 2026, with pivotal data expected mid-2027 and BLA submission expected to follow in the second half of 2027 Presented updated ronde-cel data in more than 100 patients
First patients dosed in aleniglipron (oral small molecule GLP-1 receptor agonist) Phase 3 ACCOMPLISH program for chronic weight management Data from Phase 1 SAD clinical trial of ACCG-2671 (oral small molecule dual amylin and calcitonin receptor agonist) and initiation of MAD clinical trial on
Selected z ovegalisib plus atirmociclib as go-forward triplet regimen for 1L breast cancer; Phase 3 1L trial in endocrine - sensitive patients expected to initiate in early 2027, subject to regulatory feedback Presented initial positive clinical data from Phase 1/2 ReInspire trial in vascular
Company pivot to neuro-ophthalmology continues with Privosegtor positioned as lead late-stage asset through the registrational PIONEER program with expansion potential in acute multiple sclerosis (MS) relapses following positive FDA pre-IND feedback Enrollment progressing as planned in the
August 25, 2026 U.S. PDUFA target action date for zanidatamab has potential to unlock a $250 million U.S. approval milestone and up to $190 million in potential additional global regulatory milestones Acquisition of Theravance Biopharma, Inc. expected to close in 2H 2026, adding durable
– Company reports record demand for YCANTH® as dispensed applicator units grew to 19,626 in Q2 2026, up 28.3% over the previous quarter and 46.1% year-over-year – – Topline data from global Phase 3 program studying common warts currently expected in mid-2027 – – The Company’s cash runway could
Reported topline data from 400-person sentinel cohort of the Phase 2b COVID-19 trial; Topline data from 400-person sentinel safety cohort and approximately 5,000 participants in main cohort anticipated in first half of 2027 Cash, cash equivalents, and investments of $64.0 million as of June 30,
Strategic milestone advancements for lead clinical candidate PH-762 Initiation of commercial scale API, long term non-clinical toxicology, completion of Phase 1b pharmacology, and new IP announcementsKing of Prussia, Pennsylvania--(Newsfile Corp. - August 6, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...
All Active Patients Successfully Reached Highest Planned Dose Levels of 48 mg and 64 mg in Ongoing Phase 1 Part 3 Study of DA-1726 16-Week Topline Data Expected in the Fourth Quarter of 2026 CAMBRIDGE, Mass., Aug. 6, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology
Raising 2026 Revenue and Net Income Guidance Based on Increased Demand for NERLYNX LOS ANGELES --(BUSINESS WIRE)--Aug. 6, 2026-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the second quarter ended June 30, 2026.
Advancing the Alector Brain Carrier (ABC) blood-brain barrier platform across antibodies, enzymes, and siRNA, with AL137 advancing as Alector’s lead ABC -enabled anti-amyloid beta (Aβ) antibody program for Alzheimer’s disease (AD). Continued progress across AL064/AL164 ( ABC -enabled Tau siRNA for
Advanced next-generation gamma delta (γδ) T cell engager (TCE) platform demonstrating a novel mechanism for γδ T cell expansion, deep target cell depletion, and favorable cytokine profile; Initial in vivo data expected in the second half of 2026 Presented updated data at ASCO 2026 demonstrating
NDA submission for azetukalner on track for Q3 2026 following pre-NDA meeting with FDA Phase 3 X-TOLE3 study in FOS and X-ACKT study in PGTCS continue to enroll Three Phase 3 studies of azetukalner in neuropsychiatry continue to advance, with topline data from X-NOVA2 study in MDD expected H1 2027
NAARDEN, The Netherlands and MIAMI, Aug. 06, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”)
— Facility will support YCANTH® commercialization, global Phase 3 program for YCANTH® in common warts and general corporate operations — — Facility provides potential for no scheduled interest or principal payments until maturity in December 2030 — — Facility provided by an entity controlled by
AVMAPKI® FAKZYNJA® CO-PACK net product revenue of $25.1 million First patients dosed in all three TARGET-D Phase 2 registration-directed clinical trials evaluating VS-7375 across 2L PDAC, 2L/3L NSCLC, and 2L+ CRC Updated clinical data for VS-7375 across pancreatic, lung, and colorectal cancers
- VY7523 clinical data and VY1706 clinical entry, both in Alzheimer’s, expected Q4 2026 - - Ended Q2 2026 with cash position of $149 million, runway into 2028 - LEXINGTON, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to
Enrollment completed in TX45 APEX Phase 2 clinical trial in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”) with topline results anticipated in early Q1 2027 TX45 APEX Phase 2 clinical trial Independent Data Monitoring Committee
Announced Proposed Merger with Avere Therapeutics Preserving Capital in Support of Merger Closing; Continuing Clinical Transition and Legacy Asset Activities BELTSVILLE, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to
Strong first full quarter of AVLAYAH™ (tividenofusp alfa-eknm) launch generated $3.6 million in net product revenue Advanced TransportVehicle™ portfolio with two Alzheimer’s disease programs now in clinical development $195 million in gross proceeds received in July 2026 from sale of a Priority
Enrollment in soquelitinib registrational Phase 3 relapsed/refractory peripheral T-cell lymphoma (PTCL) and Phase 2 atopic dermatitis trials on track Soquelitinib’s potential in atopic dermatitis and broader immunology and inflammation indications supported by Phase 1 clinical, immunologic and
Barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2) ongoing, topline data expected in Sept/ Oct 2026; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling; Phase 2 topline data
COPENHAGEN, Denmark, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it plans to report second quarter 2026 financial results and provide a business update on Thursday, August 13, 2026, before the open of the U.S. financial markets.
Broad label to address high unmet need in advanced melanoma Replimune will host conference call on August 6, 2026 at 4:30 p.m. ET. WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel
First patients treated with agenT-797 were alive and afebrile at endpoint Day 28 with improved oxygenation, infection control and removal from ventilator and vasopressor support Analysis of blood and lung fluid showed signals of infection control and biological changes associated with immune
August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant
SAN FRANCISCO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio, Inc. (Nasdaq: KYNB) will announce second quarter 2026 financial results on Thursday, August 13 after market close. Kyntra Bio will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further
Collaboration supports development of a next-generation AWS-native platform designed to accelerate commercialization, scalability and enterprise adoption SARASOTA, FLA., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a manag...
MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that it will release its financial results for
Repeat dose of fasedienol demonstrated favorable safety and tolerability similar to single dose Efficacy signals were observed across primary and secondary endpoints in repeat dose and single dose Prespecified analysis of patients with very severe social anxiety disorder demonstrated nominally
NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced that it will report financial results for the
PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC anticipated in the near-term BLA completion for HR BCG-unresponsive NMIBC expected fourth quarter 2026 Phase 3 BOND-003 Cohort C Study Results published in The Lancet Oncology,
PLYMOUTH MEETING, Pa., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the Piper Sandler Virtual CNS Symposium on Thursday, August 13, 2026, at 1:30 p.m. ET.
One-year data demonstrated sustained benefit of once-weekly canvuparatide as a potential PTH replacement therapy in chronic hypoparathyroidism; Phase 3 pivotal trial now recruiting Initial Phase 1 data for MBX 4291, a GLP-1/GIP co-agonist prodrug for obesity, support potential for once-monthly
Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) progressing towards closing Completed enrollment of 42 planned subjects in the Phase 1 AVALON trial evaluating VTP-1000 in patients with celiac disease; topline data from multiple ascending dose ("MAD") expected in the fourth quarter
– On track for mid-2027 topline data readout from 80 patients in the Phase 2 ASPEN-09-Breast clinical trial evaluating evorpacept in combination with trastuzumab and chemotherapy in HER2-positive metastatic breast cancer – – Presented encouraging Phase 1b/2 breast cancer data at ESMO Breast Cancer
Early Outcomes Reinforce the Consistency and Reproducibility of Tanruprubart Treatment Effect Previously Demonstrated in Phase 3 and Real-World Evidence Studies Potential to Become the First Approved Targeted Therapy to Treat GBS Worldwide, Addressing the Significant Unmet Need and Over $20
— A single locally administered intra-articular injection of PCRX-201 into the knee was well tolerated in patients with moderate-to-severe knee osteoarthritis — — Exploratory clinical outcome measures showed improvements out to two years in pain, stiffness, and function across all doses and groups
SAN DIEGO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio ® ” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that
Phase 3 CATT1 trial evaluating cadisegliatin for the treatment of type 1 diabetes (T1D) expected to complete enrollment in third quarter of 2026 Cadisegliatin Phase 2a hybrid closed-loop trial (Hybrid CATT1) in T1D to initiate before year end 2026 Strong balance sheet expected to fund operations
Mid-cycle meeting completed for ulixacaltamide HCl; FDA identified no major safety or efficacy concerns to date and does not plan to request an advisory committee meeting; PDUFA date of January 29, 2027 Mid-cycle meeting completed for relutrigine; FDA identified no major safety or efficacy concerns
TransCon ® CNP and TransCon hGH combination therapy Week 78 data from the Phase 2 COACH Trial showed durable, unprecedented increase in healthy, proportional growth TransCon CNP monotherapy Week 104 data from the pivotal ApproaCH Trial demonstrated durable improvements in height, body
August 6, 2026 – 7:45 AM ET Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology innovation company today announced that Avena Merger Sub Inc. (“ Purchaser ”), a wholly-owned subsidiary of argenx BV (“ argenx ”), has commenced a tender offer to purchase all of the
– DSMB recommends advancement of PGN-EDODM1 into the highest dose cohort in the FREEDOM2-DM1 study, as well as FREEDOM-OLE dose escalation from 5 mg/kg to 10 mg/kg – – 10 mg/kg FREEDOM2-DM1 cohort fully enrolled, with 7 of 8 participants having completed dosing; data expected in November – –
Enrollment complete in Phase 3 SONATA-HCM study; top-line data expected Q1 2027 NDA resubmission activities for ZYNQUISTA ® in type 1 diabetes nearing completion Phase 1 clinical development of LX9851 ongoing by Novo Nordisk Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, Aug.
The Company expects feedback from the FDA this quarter regarding the COMPANION-002 Phase 2/3 data for tovecimig (DLL4 x VEGF-A bispecific antibody) in patients with biliary tract cancer (BTC), prior to a potential BLA filing later this year. Tovecimig data from this study has also been selected for
– DSMB also recommended dose escalation in FREEDOM-OLE from 5 mg/kg to 10 mg/kg – BOSTON --(BUSINESS WIRE)--Aug. 6, 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
RGX-202 BLA submission for Duchenne muscular dystrophy on track for Q3 2026 initiation, with potential accelerated approval in 2H 2027 Long-term surabgene lomparvovec (sura-vec, ABBV-RGX-314) data highlight durable safety and efficacy profile ahead of key catalyst Topline data from pivotal
Generated second quarter 2026 XDEMVY ® net product sales of $173.9 million, an increase of more than 69% year-over-year Increased full-year 2026 XDEMVY net product sales guidance to $685-705 million Pending acquisition of Alkeus Pharmaceuticals to expand Tarsus’ retina pipeline with a Phase 3
IRVINE, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (Nasdaq: TARS) (“Tarsus”) today announced that it has entered into a securities purchase agreement with certain qualified institutional buyers and accredited investors for a private investment in public equity (“PIPE”)
Conference Call and Webcast Today at 8:30 a.m. ET Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate Phase 3 this quarter Granted Regenerative Medicine
Adds a potential blockbuster opportunity with gildeuretinol (ALK-001), a differentiated Phase 3 oral investigational medicine designed to target the underlying biology of Stargardt disease, one of the largest inherited retinal diseases with no FDA-approved therapy 400+ individuals treated to date,
U.S. Amtagvi Revenue Reaches ~$91M and Total Revenue Increased 66% Year-over-Year Gross Margin Increased to 56% Fast Track Designation (FTD) Granted by the FDA for Lifileucel in Soft Tissue Sarcomas SAN CARLOS, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc.
- First clinical biopsy evidence of direct cccDNA elimination from ongoing Phase 1 ELIMINATE-B trial; PBGENE-HBV treatment led to a 1-log reduction in cccDNA with
KRRO-121, a potential first-in-class transformational treatment for hyperammonemia, remains on track to commence first-in-human clinical trial in second half of 2026 Received Orphan Drug Designation from the European Medicines Agency (EMA) for KRRO-121 for patients with urea cycle disorders (UCDs)
Commercial preparations for brepocitinib in dermatomyositis (DM) are progressing well and on track for launch by the end of September 2026; topline data from Phase 3 study in non-infectious uveitis (NIU) expected in the second half of calendar year 2026 First patients enrolled in the Phase 3 study
CS is a highly morbid, chronic, and disfiguring condition with no approved therapies Brepocitinib is the first investigational therapy to generate a positive result in a placebo-controlled CS study (Phase 2 BEACON) and has received FDA Breakthrough Therapy Designation for CS Global Phase 3 study
Completed enrollment and dosing for GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease (CVD) risk; readout anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk and cardiometabolic
CLYM116 Phase 1 data in healthy volunteers to be presented at R&D Spotlight Event on September 3, 2026 Anticipate CLYM116 Phase 2 trial in IgA nephropathy to initiate dosing in Q3 2026 Budoprutug clinical programs continue to advance, with data expected from pMN, ITP, and SLE studies in Q4 2026
CLN-978 (CD19 TCE) multi-dose regimen data in RA in Q3 2026 and SLE in Q4 2026; Phase 2 expansion studies to begin early 2027 Velinotamig (BCMA TCE) multi-dose regimen data in SLE in Q4 2026; Phase 1/2 basket study in autoimmune cytopenias to begin early 2027 CLN-049 (FLT3 TCE) potentially
PreciSION CF Phase 2a proof-of-concept trial evaluating NBD1 stabilizer SION-719 as an add-on to standard of care is on track for topline data summer of 2026 Phase 1 trial evaluating NBD1 stabilizer SION-451 in proprietary dual combinations with SION-2222 and with SION-109 also is on track for
BOSTON, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today
Worldwide revenue of $388.2 million in the second quarter of 2026 GAAP fully diluted earnings per share of $1.11, compared to $1.12 in the second quarter of 2025 Adjusted fully diluted earnings per share of $1.55, compared to $1.57 in the second quarter of 2025 Announced on August 3, 2026 that it
First pivotal cohort enrolled 300 subjects, with topline clinical data from 24-week primary endpoint on track for December 2026 release Completion of enrollment in the second pivotal cohort evaluating 600 subjects across the PEAK and PINNACLE studies is expected in 4Q 2026, with topline clinical
Infinitum founder and Groq board director brings frontier AI and technology-investing expertise to Biohaven as the company advances AI-enabled approaches to drug development NEW HAVEN, Conn., Aug. 6, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global biopharmaceutical company, today
Last participant completed final study visit in the 16-week double-blind period of the pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia; topline data on track and anticipated in late August or early September 2026 Cash runway expected to fund operations into 2028
Delivers Total Revenues of $3.8 Billion, Representing 5% Reported Growth Compared to Second Quarter 2025 and a U.S. GAAP Net Loss of $119 Million Total Revenues Were Up 3.5% Operationally Compared to Second Quarter 2025 Adjusted EBITDA was $1.2 Billion, Up 8% Operationally Compared to Second
- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Validate Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Timelines Reaffirmed for Upcoming Top Line Results from Phase 1b Proof-of-Concept (POC) Trials of ATI-052 and Phase 2 Trial of Bosakitug
People with AAE-C1INH experience frequent misdiagnoses, emergency medical events, and wide-ranging impact on physical, emotional, and social well-being Study results informed the design and endpoint selection of the ongoing Phase 3 CREAATE study ZUG, Switzerland, Aug.
EMA also accepts application for the same population for ENFLONSIA based on results from the Phase 3 SMART trial If approved, children under two years of age at increased risk for severe RSV disease will be eligible to receive an additional dose of ENFLONSIA for their second RSV season RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE:...
The Company advanced multiple global oncology and immunology programs toward key clinical and regulatory milestones, with significant pipeline catalysts expected in the second half of 2026 Global Phase 1 data for zocilurtatug pelitecan (zoci) in combination with a PD-L1 inhibitor in first-line SCLC
IRVINE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced that it will host a live webcast at 5:00 a.m. PT / 8:00 a.m. ET on Thursday, August 6, 2026 to report its second quarter 2026 financial results and provide a corporate update.
LOS ANGELES --(BUSINESS WIRE)--Aug. 5, 2026-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on August 3, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 35,375 shares of Puma
First participant dosed in QUELL-CV, a Phase 2 dose-ranging proof-of-concept trial of BGE-102 measuring inflammatory and cardiometabolic biomarkers; topline data anticipated in the second half of 2026 QUELL-DME, Phase 1b/2a proof-of-concept trial of BGE-102 in diabetic macular edema, planned to
– LOQTORZI ® net revenue of $13.6 million in Q2 2026, up 15% over Q1 – – Clinical data continue to mature across programs with emerging evidence of activity with tagmokitug in head and neck cancer – – Projected October public disclosure of data sets with sufficient maturity – – Conference call
Prioritization of CTIM-76 and CT-202 clinical programs, with initial clinical readouts expected beginning in Q2 2027 Cash and cash equivalents of $43.0 million as of June 30, 2026 expected to fund operations into Q4 2027 PHILADELPHIA, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Context Therapeutics Inc.
WOBURN, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a U.S. specialty dermatology company commercializing Ameluz ® (aminolevulinic acid hydrochloride) Gel, 10% with the BF-RhodoLED ® lamp for photodynamic therapy (PDT) of a...
Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of
Positive Interim Data Shared in 2Q 2026 from the MyPEAK™-1 and RIDGE™-1 Clinical Trials Each Demonstrated Meaningful Improvements in Key Disease Characteristics Additional Data Releases Plus Updates on Regulatory Discussions on Pivotal Trial Plans for TN-201 and TN-401 Anticipated in 4Q 2026 TN-301
Topline Safety, Tolerability and Immunogenicity Data from VAX-31 Adult Phase 3 OPUS-1 Trial Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Phase 3 Results Expected in First Half of 2027 Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose of
Enrollment ongoing for the Phase II COVALENT-211 clinical trial in patients with insulin deficiency in Type 2 diabetes (“T2D”); data expected in the first quarter of 2027 Enrollment also ongoing for the Phase II COVALENT-212 clinical trial in patients with T2D not achieving glycemic targets while
CAMBRIDGE, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- As previously announced, Wave Life Sciences Ltd. (NASDAQ: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health (“ Wave ” or “ Wave Life Sciences ”), has obtained the
New CEO Michael Severino, MD, brings extensive biopharma leadership and a proven track record of advancing innovation, building franchises, and delivering growth Net product revenues for the second quarter 2026 totaled $328.7 million, consisting of $230.6 million of PMO net product revenue and
- Total Revenues of $628.7 million, Cabozantinib Franchise U.S. Net Product Revenues of $573.0 million - - GAAP Diluted EPS of $0.82, Non-GAAP Diluted EPS of $0.91 - - Conference Call and Webcast Today at 5:00 PM ET - ALAMEDA, Calif. --(BUSINESS WIRE)--Aug. 5, 2026-- Exelixis, Inc.
Q2 2026 Vafseo ® (vadadustat) net product revenues grew to $21.3 million; more than 10,500 p atients now on therapy Advancement of rare kidney disease pipeline continues with initiation of Phase 2 open-label basket trial evaluating ebribafusp for treatment of IgA nephropathy, lupus nephritis and
U.S. FDA accepted daraxonrasib New Drug Application for review for previously treated metastatic pancreatic cancer following unprecedented Phase 3 RASolute 302 results Rapidly implemented U.S. Expanded Access Program for eligible patients with previously treated metastatic pancreatic cancer
Achieved three major catalysts to drive future growth: Launched the pediatric indication of Afrezza ® following FDA approval FUROSCIX ReadyFlow™ autoinjector approved for treatment of edema in HF and CKD Positive nintedanib DPI Phase 1b data in IPF patients validates continued Phase 2 advancement
-- XmAb819 ccRCC expansion cohorts to be presented in an oral session at ESMO 2026; multiple Phase 1 sub-studies in earlier lines of therapy and additional indications now open for enrollment or planned -- -- XmAb942 enrollment in XENITH-UC remains on track with primary endpoint of the 12-week
EDIT-401 on track for CTN submission this month with data update in Q1 2027 Recently presented pre-clinical data demonstrating ~90% or greater mean reduction in multiple atherogenic lipoproteins, including LDL-C, Lp(a) and ApoB with EDIT-401 in non-human primates Recent financing strengthens
Continued strong ZORYVE ® (roflumilast) net product revenue growth, with Q2 revenues of $129.9 million, +59% versus Q2 of 2025, and +23% versus Q1 of 2026, driven primarily by strong demand growth Company raising 2026 full-year net product sales guidance to $525 million–$540 million Received
NEWTON, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble amyloid beta oligomers for the treatment of Alzheimer’s disease, today
As announced, Jaguar received an upfront payment of $16M of non-dilutive capital in January 2026 upon entering U.S. license agreement with Future Pak for Mytesi ® and Canalevia ® -CA1 - Jaguar's two commercialized crofelemer drugs - an agreement that is fully aligned with company's strategy to
ROCKVILLE, Md., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to
ZUSDURI ® generated $50.4 million in revenue in the second quarter of 2026, representing 73% quarter-over-quarter growth Once issued, new U.S. patent is expected to provide protection into July 2044 for ZUSDURI and UGN-103 Continued advancement of pipeline, with UGN-103 on track for NDA submission
-- DMR-001 is a highly potent, long-acting antibody therapy targeting Type 1 and non-Type 1 mutant calreticulin (mutCALR), designed for convenient once-monthly subcutaneous dosing -- -- In preclinical studies, DMR-001 demonstrated up to 30-fold greater potency and an approximately five-fold longer
GAITHERSBURG, Md., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that it will report its second quarter 2026 financial results on Wednesday, August 12, 2026.
WAYNE, Pa., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are
SAN DIEGO, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced it will report its second quarter 2026 financial results after the close of the U.S
Portfolio Receipts growth of 6% to $773 million; Royalty Receipts growth of 14% Net cash provided by operating activities of $728 million Raised full year 2026 guidance: Portfolio Receipts expected to be $3,400 million to $3,500 million NEW YORK, NY, August 5, 2026 — Royalty Pharma plc (Nasdaq:...
RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will release its second quarter 2026 financial results before the opening of the U.S.
RAP-219 Phase 3 program in focal onset seizures initiated, with FOCUS 1 and FOCUS 2 trials enrolling patients RAP-219 Phase 2 trial in bipolar mania on track for topline results in October 2026 Pipeline continues to advance, including the RAP-219 long-acting injectable and primary generalized
-- Company to report ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026 -- -- ELEVATE-44-201 Cohort 2 enrollment complete with data expected in Q1 2027 -- -- Company to report ELEVATE-45-201 Cohort 1 data in October 2026 -- -- ELEVATE-45-201 Cohort 2 dosing ongoing at the
Achieved $57.5 million in RYTELO ® (imetelstat) net product revenue in Q2 2026, an increase of 11% compared to Q1 2026 Reiterated 2026 RYTELO net product revenue and total operating expenses expected to be in the ranges of $220 million to $240 million, and $230 million to $240 million, respectively
– Announced positive CHMP opinion recommending marketing authorization for obicetrapib and obicetrapib/ezetimibe – – PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027 – – Topline data from RUBENS Phase 3 expected by year-end 2026 – – $678.3 million in cash, cash equivalents
Enrollment completed in KT-621 (STAT6) BROADEN2 Phase 2b AD trial nearly six months ahead of anticipated timeline, with data expected by year-end 2026 KT-621 Phase 3 trials in AD planned to initiate by mid-2027 KT-621 BREADTH Phase 2b asthma trial ongoing, with data expected to be reported in late
— Total net revenue of $218.3 million and ORLADEYO ® net revenue of $158.2 million — — Operating profit of $98.5 million and Non-GAAP operating profit of $113.2 million — — Maintained Full Year 2026 ORLADEYO revenue guidance of $625 to $645 million and increased total revenue guidance to $690
MELBOURNE, Australia and INDIANAPOLIS, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today advises that it will host a Research and Development (R&D) Day on Tuesday, September 22, 2026, from 8:30 a.m. to 12:30 p.m. EDT in New York City.
RMAT designation granted based on recent interim clinical data from ongoing Phase I/II clinical trial evaluating LX2020 for PKP2-ACM LX2020 now holds RMAT, Orphan Drug and Fast Track designations by the FDA NEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc.
BOSTON, Aug. 05, 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 it will host a live
– Topline data from LUGANO pivotal Phase 3 wet AMD clinical trial expected in August 2026 –– – Topline data from LUCIA pivotal Phase 3 wet AMD clinical trial anticipated in Q4 2026 –– – Pivotal Phase 3 DME clinical trials, COMO and CAPRI, fully enrolled over 480 patients in 5 months; topline data
AC Immune First Half 2026 Financial and Corporate Update Focused portfolio of wholly-owned programs approach near-term clinical catalysts as partnered programs generate milestone payments Key advances across pipeline, with further near-term clinical results anticipated for H2 2026 Phase 2 VacSYn
-- Reported positive bempikibart 36-week topline results from Part B of SIGNAL-AA clinical trial; additional details from 36-week results and initial findings from 52-week results to be presented at a medical conference in the second half of 2026 -- -- Patient enrollment and dosing in SIGNAL-AA
ASN-001 targets the substantially larger population of moderate infantile hemangiomas currently treated off-label with topical timolol Complementary product to HEMANGEOL ® (propranolol hydrochloride) oral solution, positioning Eton, if approved, to treat full spectrum of infantile hemangioma
Revenue in Q2 2026 increased 48% to $23.0 billion driven primarily by Mounjaro and Zepbound volume. Q2 2026 EPS increased by 26% to $7.94 on a reported basis and increased by 33% to $8.38 on a non-GAAP basis. Q2 2026 reported and non-GAAP EPS included $3.03 of acquired IPR&D charges compared to
Genentech advanced the collaboration's first neuroscience target into a joint early discovery program, providing early evidence that Recursion's platform can generate novel, biologically validated targets for drug discovery REC-4881 (MEK1/2 inhibitor): Additional Phase 2 data in Familial
SAN FRANCISCO, Aug. 04, 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 that
Recognized leader in cardiovascular medicine and human genetics brings extensive experience spanning scientific innovation, therapeutic discovery, and clinical leadership as Editas advances EDIT-401 to the clinic CAMBRIDGE, Mass., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq:
Second quarter total revenue of $214 million, Crysvita ® revenue of $156 million and Dojolvi ® revenue of $27 million Reaffirm 2026 financial guidance, including total revenue of $730 million to $760 million and combined R&D and SG&A expenses to be flat to slightly down versus 2025; remain on path
SOUTH SAN FRANCISCO, Calif., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that
-- Executing IND-enabling activities for next-generation PI3Kα pan-mutant selective candidates OKI-345 in breast cancer and OKI-355 in vascular anomalies, with IND submissions planned for 1H 2027 -- Hosted a Key Opinion Leader event highlighting the evolving PI3Kα treatment landscape and the
- Initial Ph2 data from SURF302 expected in September 2026 (n>40 enrolled to date) - - Initial Ph2 data from safety sentinel cohort (aggregate of ~25 children) in BEACH301, including new 5 th dose level, now expected end of Q1 2027 - - Appointed Jonathan Day as EVP, Clinical Development to advance
Announced positive topline induction data for SPY001 and SPY002 from Part A of the Phase 2 SKYLINE trial (“SKYLINE”), demonstrating best-in-class efficacy potential and a safety profile consistent with in-class comparators Announced enrollment completion for the Phase 2 SKYWAY basket trial
-- Continued execution of 5x30 strategy marked by solid revenue growth, durable cashflows, advancing pipeline, and high-caliber commercial partnerships -- -- Delivered second quarter total revenue of $192.4 million, representing 6 percent year-over-year growth -- -- Conference call today at 4:30
Advancing a neuromuscular franchise with claseprubart, a highly potent investigational classical pathway inhibitor, with best-in-disease potential across generalized Myasthenia Gravis (gMG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN) Phase 3
– Total revenue of $73 million in 2Q26, a 92% year-over-year increase – – Revuforj ® (revumenib) net revenue of $54.7 million in 2Q26, a 91% year-over-year increase – – Niktimvo™ (axatilimab-csfr) net revenue of $60.3 million in 2Q26, a 67% year-over-year increase, resulting in Syndax collaboration
NEW YORK --(BUSINESS WIRE)--Aug. 4, 2026-- Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the Compensation Committee of the Company’s Board of Directors
BOSTON, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (Nasdaq: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that on August 3, 2026, the Compensation Committee of Praxis’ Board of Directors
- Conference Call and Webcast Today, August 4, 2026, at 4:30 p.m. ET PASADENA, Calif. --(BUSINESS WIRE)--Aug. 4, 2026-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2026 third quarter ended June 30, 2026.
THOUSAND OAKS, Calif., Aug. 4, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the second quarter of 2026. "Our results demonstrate strong performance across our business. Our six key growth drivers grew 26% year over year, generating nearly 70% of second-quarter
DALLAS, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today
- Voucher to be used to accelerate review of a planned sNDA for plozasiran in severe hypertriglyceridemia PASADENA, Calif. --(BUSINESS WIRE)--Aug. 4, 2026-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has signed an agreement with an undisclosed third party to acquire a
LOS ANGELES, CA, Aug. 04, 2026 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), the global leader in relapsed/refractory AL Amyloidosis, today announced that it will participate and host institutional investor meetings at the Morgan Stanley 24th Annual Global Healthcare Conference being held September 14-16, 2026 in...
Discussion explores how combining complementary payload technologies may unlock new therapeutic opportunities while reinforcing the versatility of Akari's proprietary PH1 spliceosome-modulating payload platform Access the Akari CEO Corner here TAMPA, Fla. and LONDON, Aug.
CAMBRIDGE, Mass., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced that members of Wave’s management team are scheduled to participate
TEL AVIV, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that post-hoc data from its Phase 2 clinical trial of EB613 (oral PTH(1-34) tablet) has been selected for two presentations including
Conference Call and Webcast Scheduled for August 12, 2026 at 2:00 p.m. PT / 5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T)
Salt Lake City, UT, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX), a leading clinical-stage TechBio company decoding biology to radically improve lives, today announced its participation in the following upcoming investor conferences: Bank of America 2026 SMID Cap Executive Insights
First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of 2026 Preparing for a planned standalone U.S. commercial launch of QTORIN™ rapamycin for microcystic lymphatic
WAKIX® Net Revenue Grew 30% Year over Year to $261.3 Million for Second Quarter 2026; Estimated Average Patients Increased 450 to 8,950; Reiterates 2026 WAKIX Net Revenue Guidance of $1.0 Billion to $1.04 Billion Phase 1 SAD Data for BP-205 Demonstrate Favorable PK and Safety/Tolerability Profiles;
Q2 2026 net product revenue of $50.7 million, up 92% year-over-year and 15% sequentially from Q1 2026, marking the eighth consecutive quarter of sequential revenue growth since the commercial launch of ANKTIVA ®, driven by continued adoption among U.S.
NEW HAVEN, Conn., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that on August 1, 2026, Invivyd granted ten newly hired non-executive employees options to purchase an aggregate of 277,500 shares of its common stock, each as a material inducement for each employee’s
DNTH312 is an internally developed bifunctional fusion protein targeting potent inhibition of active C1s (aC1s) and BAFF/APRIL, two validated pathways with complementary disease modifying mechanisms DNTH312 demonstrated comparable in vitro potency and aC1s inhibition to claseprubart, with a
– Secured the first-ever regulatory approval of a PROTAC (a type of heterobifunctional protein degrader), VEPPANU, and successfully completed out-licensing to Rigel Pharmaceuticals – – Anticipates sharing clinical data from three Phase 1 programs - ARV-393, ARV-102 and ARV-027 - over the next 12
Lisata has filed suit against Kuva Labs Inc. and its subsidiary seeking, among other things, damages for the benefit of its stockholders Lisata’s Board of Directors and management continues to evaluate strategic alternatives to enhance stockholder value In order to reduce operating expenses and
Updated BEAM-302 Phase 1/2 Clinical Data Selected for Late-Breaking Oral Presentation at the European Respiratory Society (ERS) Congress 2026 Dosing Complete for All Adult and Adolescent Patients in Phase 1/2 BEACON Trial of Risto-cel in Sickle Cell Disease; U.S.
FOSTER CITY, Calif., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that management will participate in the Canaccord Genuity
BOSTON, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody,
Positive longer-term open label study data further demonstrated nomlabofusp's well-characterized safety profile, sustained increases in skin frataxin levels, and continued improvements in key clinical outcome measures High patient and investigator enthusiasm continues with additional participants
PITTSBURGH, Aug. 4, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today announced that on August 3, 2026, its Board of Directors declared a quarterly dividend of $0.12 per share for each issued and outstanding share of the Company's common stock. The dividend is payable on September 16, 2026,
Guido Oelkers, Ph.D., appointed to BioNTech Management Board as Chief Executive Officer, taking office by February 1, 2027, at the latest Advanced diversified pipeline now with 14 ongoing pivotal clinical trials and more than ten novel-novel combinations across major tumor types Multiple milestones
Sales Growth Reflects Continued Strength in Oncology, Including Initial Uptake of KEYTRUDA QLEX, and Animal Health, Plus Contributions From Launches Such as WINREVAIR Financial Highlights Total Worldwide Sales Were $16.6 Billion (5% Growth; 4% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.4 Billion (5% Growth; 4% Growth ex-FX);...
NEW YORK and WALTHAM, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced that it granted equity awards
BOSTON, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that, on August 1, 2026, the Compensation Committee of the Board of Directors granted stock options to purchase an aggregate of
PASADENA, Calif. --(BUSINESS WIRE)--Aug. 3, 2026-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that as an inducement to entering into employment with the Company, on July 16, 2026, the Company’s Board of Directors approved “inducement” grants to 95 new employees under Rule
ALISO VIEJO, Calif., Aug. 03, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX ® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S.
ZUG, Switzerland and BOSTON, Aug. 03, 2026 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) today reported financial results for the second quarter ended June 30, 2026. "The second quarter reflected strong execution across CRISPR Therapeutics' portfolio and platform," said Samarth Kulkarni,
Initiated Himalayas-1 global Phase 3 trial in patients with mCRPC previously treated with abiraterone Entered into a clinical trial collaboration and supply agreement with Bayer to provide darolutamide for Himalayas-1 Anticipate rinzimetostat program update in 2H 2026 and enozertinib clinical
NEEDHAM, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced that on July 31,
LONDON and GAITHERSBURG, Md., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced that the Company will release its second
BURLINGTON, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced that it will report financial results
– Continued commercial execution drives record total revenues of $1.2 billion (+16% YoY) – – Company raises 2026 revenue guidance – – Prepared to launch Ziihera ® in HER2+ 1L GEA immediately following FDA approval – – Xywav ® revenues grew 13% YoY with 525 net patient adds in 2Q26 – – Epidiolex ®
SAN DIEGO, Aug. 03, 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 broadly to patients with cancer and autoimmune
CAMBRIDGE, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics ®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, granted 2 newly-hired employees options to purchase an aggregate of 61,000 shares of Akebia’s
— Total revenue of $3.33 billion, a 12% increase compared to second quarter 2025 — — Raising full-year revenue guidance to $13.1 billion to $13.2 billion — — Continued progress across research and development pipeline; povetacicept PDUFA date November 30th — — Entered into agreement to acquire
BOSTON, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Damora Therapeutics, Inc. (NASDAQ: DMRA) (“Damora”), a biotechnology company working to fundamentally redefine care for patients with blood disorders, today announced that it granted equity awards to six newly-hired, non-executive employees on August 1,
August 3, 2026 – 22:01 PM CEST Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Extraordinary General Meeting of Shareholders will
Company to host investor conference call and webcast at 4:30 p.m. ET. Cambridge, Massachusetts, Aug. 03, 2026 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company developing antibody therapeutics and vaccines targeting toxic misfolded proteins in neurodegenerative diseases, today announced it will report...
3 August 2026 Notification of Admission of Further Securities to Trading (PRM 1.6.4R) The following notification is made in accordance with The Public Offers and Admissions to Trading Regulations 2024 (POATRs) PRM 1.6.4R....
3 August 2026 Total Voting Rights The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6.1. As at 31 July 2026 the issued share capital of AstraZeneca PLC with voting rights is 1,551,033,389 ordinary shares of US$0.25. No shares are held in Treasury....
CAMBRIDGE, Mass. --(BUSINESS WIRE)--Aug. 3, 2026-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its second quarter 2026 financial results on Thursday, August 6, 2026. Amylyx’s senior management team will host a conference call and audio webcast at 8:00 a.m.
Milestone Advances Ampligen® Toward Key Clinical Benefit Readout in December 2026 and Overall Survival Analysis in Mid-2027 OCALA, Fla., Aug. 03, 2026 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American:...
NEW YORK, NY, August 3, 2026 — Royalty Pharma plc (Nasdaq: RPRX) today announced the appointment of Greg Raskin, M.D. as Senior Vice President, Head of Academic Initiatives, effective August 2026. Greg will lead Royalty Pharma’s outreach efforts with academic and non-profit institutions as well as oversee the Royalty Pharma Translational Prize....
NEEDHAM, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced that an abstract was
RESTORE-FA trial modifications build on positive four-week data; expect to share data based on 12 weeks of dosing in the first quarter of 2027 Patient dosing initiated in Phase 1 multiple-ascending dose trial of DT-818 in myotonic dystrophy type 1 Cash and securities of $207.4 million at
CAMBRIDGE, Mass. and DALLAS and TAMPA, Fla., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc., (Nasdaq: TSHA) (Taysha), a clinical-stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies for rare, monogenic diseases of the central nervous
Dr. Cohen Pfeffer Brings More Than a Decade of Clinical Development Leadership, Including Deep Experience with Enzyme Replacement Therapies for Rare Pediatric Neurodegenerative Disorders SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--Aug. 3, 2026-- Spruce Biosciences, Inc.
SOUTH SAN FRANCISCO, Calif., Aug. 03, 2026 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced the appointment of Alejandra Carvajal as Chief Legal Officer. In this role, Ms.
The open-label Phase 2 trial will evaluate ebribafusp for the treatment of IgA nephropathy, lupus nephritis and C3 glomerulopathy CAMBRIDGE, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics ®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of
Global registrational study designed to evaluate pemvidutide on fibrosis improvement, MASH resolution, and clinical outcomes Initiation marks advancement of Altimmune's lead program into late-stage development following positive IMPACT Phase 2b data GAITHERSBURG, Md., Aug.
INDIANAPOLIS, Aug. 3, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration ( FDA) has granted Breakthrough Therapy designation to olomorasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have
Former President of Intra-Cellular Therapies, Inc. was instrumental in building and scaling the company, which was subsequently acquired by Johnson & Johnson Experienced executive with a proven track record of guiding pharmaceutical companies through late-stage clinical development and
Former President of Intra-Cellular Therapies, Inc. was instrumental in building and scaling the company, which was subsequently acquired by Johnson & Johnson Experienced executive with a proven track record of guiding pharmaceutical companies through late-stage clinical development and
Strategic transaction would bring Curium's theranostics portfolio and global manufacturing platform together with Lantheus’ complementary U.S. radiodiagnostics business Total transaction consideration to Lantheus shareholders of up to $114.50 per share in cash for an aggregate transaction value of
SAN DIEGO, Aug. 03, 2026 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, today announced the company will host a
Company reports preliminary Q2 2026 AUCATZYL net product revenue of approximately $45 million and gross margin of approximately 35% year-to-date FY 2026 sales guidance increased to $140 – $150 million, from $120 – $135 million Capital base strengthened through five-year, interest-only credit
ROCKVILLE, Md., Aug. 3, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Thursday, August 6, at 8:00 a.m. ET to discuss its financial results for the second quarter ended June 30, 2026, and operational highlights.
Collaboration Advances Biomarker-Driven Patient Selection and Precision Medicine in Oncology Validation Studies Aim to Optimize Clinical Trial Patient Selection Criteria AUSTIN, Texas — (Aug. 3, 2026) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ:...
Second quarter 2026 total global revenue of approximately $240 million, including BRIUMVI U.S. net product revenue of approximately $228 million Raises full year 2026 total global revenue target to approximately $950 million and raises full year 2026 BRIUMVI U.S.
Ocular’s AXPAXLI TM wet AMD NDA submission on track for Q4 2026 following positive Type C Meeting with the U.S. FDA in May 2026 FDA Type C Meeting Minutes Formalize SOL-1 Trial with Confirmatory Evidence as Sufficient to Support Submission of AXPAXLI NDA in wet AMD AXPAXLI NDA submission to be
- NECs are aggressive malignancies with poor prognoses and limited treatment options, representing significant unmet patient need - U.S. FDA Orphan Drug Designation (ODD) follows receipt of ODD for zoci in pulmonary NECs from the European Medicines Agency, reinforcing zoci’s first-in-class
$119.2 million in 2Q VYJUVEK global revenue and $965.9 million since launch Multiple clinical data readouts in 2H 2026 On track for VYJUVEK launches in Spain and Italy later this year Strong balance sheet, ending the quarter with $1.1 billion in cash and investments PITTSBURGH, Aug.
Longtime investor OPKO Health increases its position as Cocrystal advances toward norovirus Phase 1b data in late 2026 BOTHELL, Wash., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq:...
DEER PARK, Ill., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report second quarter 2026 financial
Mainz, Germany, August 3, 2026 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that its Supervisory Board has appointed Guido Oelkers, Ph.D., to the Management Board as Chief Executive Officer (“CEO”), who will take office by February 1, 2027, at the
The FDA Division of Neurology provided positive feedback supporting a regulatory pathway for Privosegtor in acute multiple sclerosis (MS) relapses, addressing a significant unmet medical need The FDA confirmed that existing Privosegtor data can be cross-referenced for a new Investigational New
Appointments put dedicated leadership behind two separate priorities: building Ascentage Pharma’s own commercial organization in the United States, and expanding its global business development program ROCKVILLE, Md., Aug. 02, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ:
Salt Lake City, UT, July 31, 2026 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, announced that on July 27, 2026, the Compensation Committee of Recursion's Board of Directors approved the grant of inducement
TEL AVIV, July 31, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that the Company’s Chief Executive Officer, Miranda Toledano, will be participating in a fireside chat at the Canaccord Genuity 46th