CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep. 23, 2026-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that management will present at the Stifel 2026 Virtual Cardiometabolic Forum. The fireside chat will take place on Wednesday, September 30 th, 2026, at 9:30
Accomplished finance and enterprise executive with over 20 years of global leadership in multinational and Fortune 500 companies BRISBANE, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing in vivo
Appointments support ProQR’s strategy to scale AI across the discovery and development of medicines using its Axiomer RNA editing platform and pipeline AX-0811, the first ProQR program identified through its AI-enabled discovered engine in clinical testing, with target engagement data expected in early January 2027 ProQR’s expanded AI strategy is directly...
GAITHERSBURG, Md., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that management will participate in a fireside chat at the Stifel 2026 Virtual
WVE-007 induces fat loss without muscle loss, with clinical data supporting 1-2x per year dosing; preclinical data demonstrate Wave’s INHBE GalNAc-siRNA in combination with GLP-1 doubled weight loss compared with GLP-1 alone Maintenance clinical trial evaluating WVE-007’s ability to curtail weight
WVE-007 induces fat loss without muscle loss, with clinical data supporting 1-2x per year dosing; preclinical data demonstrate Wave’s INHBE GalNAc-siRNA in combination with GLP-1 doubled weight loss compared with GLP-1 alone Maintenance clinical trial evaluating WVE-007’s ability to curtail weight
SAN CARLOS, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it has terminated its proposed public offering of securities, previously announced on September 22, 2026.
Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12
PASI 100 increased to 71.4% and PASI 90 increased to 87.3%, despite no dosing after Week 4 Placebo crossover patients reached PASI 100 and PASI 90 rates similar to those initially dosed with ORKA-001 ORKA-001 maintained a favorable safety and tolerability profile through Week 28 52-week EVERLAST-A
NEW YORK, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO) a clinical stage company focused on reshaping the path of genetic diseases with high unmet need, today announced that the Company will participate in a fireside chat at the Stifel 2026 Virtual Cardiometabolic Forum
Company to Highlight Next Stage of PH-762 Clinical Development in Cutaneous Squamous Cell Carcinoma King of Prussia, Pennsylvania--(Newsfile Corp. - September 23, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...
All primary endpoints of the study were met, with ACI-7104 shown to be generally safe and well tolerated Strong immunogenicity demonstrated, with 100% response rate after three immunizations Clear antibody penetration into the cerebrospinal fluid (CSF) and signals for target engagement Discussions
23 September 2026 Trixeo approved in the EU for the maintenance treatment of asthma Trixeo is the first and only triple-combination therapy approved in the EU for patients 12 years and older, independent of exacerbation history AstraZeneca's fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate or BGF...
In the phase III IMAgINATION study, sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential Sefaxersen inhibits complement factor B production at its primary source in the liver, thus blocking a key driver of IgAN-related kidney damage 1 IgAN is a...
Roche announced today that the Board of Directors of Roche Holding Ltd has approved to propose Dr. Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to the Board of Directors at Roche’s Annual General Meeting on March 9, 2027. Roche Chairman Severin Schwan:...
– Sefaxersen demonstrated statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, showing best-in-class potential – – IgAN is a progressive kidney disease that is typically diagnosed in young adults and up to 50% of people progress to kidney failure
TORONTO, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (“ Helus ” or the “ Company ”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“ NSAs ”), is pleased to announce the voting results for each of
TORONTO, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (“ Helus ” or the “ Company ”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“ NSAs ”), is pleased to announce the voting results for each of
In accordance with articles L.233-8 II of the French Commercial Code and 223-16 of the General Regulation of the French Financial Markets Authority (Autorité des Marchés Financiers) PARIS, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Market: Euronext Paris / Nasdaq Euronext Compartment: B ISIN code:
SAN CARLOS, Calif., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors,
NEW YORK, Sept. 22, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (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 William Ho, Chief Executive Officer and
Company remains sharply focused on its ongoing rare disease intestinal failure global development program for microvillus inclusion disease (MVID) and SBS for crofelemer powder for oral solution, targeting an NDA filing for MVID mid-2027 SAN FRANCISCO, CA / ACCESS Newswire / September 22, 2026 /
Dazodalibep Demonstrated Statistically Significant and Clinically Meaningful Improvement in Systemic Disease Activity Results Support the Potential for a New, Highly Differentiated Treatment Option for People Living With a Debilitating Autoimmune Disease THOUSAND OAKS, Calif., Sept.
Company CEO outlines the differentiated mechanism and clinical potential of Ampligen in pancreatic cancer Survival data highlighted in accompanying chart show Ampligen-associated median overall survival of 34.8 months in a selected pancreatic patient population versus 12.5 months in historical controls OCALA, Fla., Sept....
DOYLESTOWN, Pa., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, today announced
Fasedienol nasal spray was well-tolerated in patients with social anxiety disorder with no new drug-related safety findings after as-needed use for up to 12 months Clinically relevant improvement in social anxiety over time was observed on both clinician-administered and patient-reported scales
– First-Ever Fast Track Designation Granted for a Peeling Skin Syndrome Therapy – Second Fast Track Designation Granted to QRX003, in Addition to Netherton Syndrome – Fast Track Designation Facilitates Development and Expedites Regulatory Review of Therapies Addressing Serious Conditions with
The FDA recommended that Compass conduct a trial to demonstrate a survival benefit prior to submitting a BLA for tovecimig. Compass does not believe that a new trial is warranted prior to submitting a BLA based on the data from the Phase 2/3 COMPANION-002 study and the urgent unmet medical need for
WILMINGTON, Del. --(BUSINESS WIRE)--Sep. 22, 2026-- Incyte (Nasdaq:INCY) today announced that data from across its Inflammation and Autoimmunity (IAI) portfolio will be presented at the European Academy of Dermatology and Venereology (EADV) 2026, held September 30 - October 3, 2026, in Vienna,
PLYMOUTH MEETING, Pa. -- Sept. 22, 2026 -- Harmony Biosciences today recognized World Narcolepsy Day, observed annually on September 22, by reflecting on nearly a decade of commitment to the narcolepsy and broader sleep-wake community. Since its founding in 2017, Harmony has worked alongside
SALT LAKE CITY, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) today announced that management will participate at the 5 th Annual ROTH Healthcare Opportunities Conference and at the Lytham Partners Investor Conference Fall Event and host 1x1 investor meetings at both conferences.
– Ulefnersen demonstrated a statistically significant improvement on the primary endpoint assessing functional impairment and survival in people living with FUS-ALS, supporting the potential to modify disease progression – – Results will be discussed with the U.S.
– In people with AMKD with modest proteinuria, treatment with inaxaplin led to a reduction in urine albumin to creatinine ratio (UACR) of -42.7% at Week 13 compared to baseline – - In people with AMKD and type 2 diabetes, treatment with inaxaplin led to a reduction in UACR of -17.3% at Week 13
HOUSTON, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing multi-antigen recognizing (MAR)-T cell therapies for the treatment of hematologic malignancies and solid tumors, today highlighted the expanded infrastructure,
Approval of BRAVNETSA expands radioligand treatment options for adult patients with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) BEDFORD, Mass., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc.
Phase 1 study with ADG138 for patients with advanced solid tumors is expected to begin in China in the fourth quarter of 2026 ADG138 is a double-masked T-cell engager, applying Adagene’s proprietary SAFEbody® precision masking technology on both HER2 and CD3 binding sites to enable tumor-selective
Dr. Vnuk brings substantial business and corporate development leadership experience from Sanofi, Blackstone, and Pfizer CAMBRIDGE, Mass., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA
– New data from the Phase 3 INDIGO open-label extension will include the longer-term flare protection and safety data of obexelimab in IgG4-RD – – Additional analyses will assess glucocorticoid-associated toxicity and vaccine responses – WALTHAM, Mass., Sept.
Acquisition of Mantle Therapeutics will add multiple new modalities designed to increase or replace frataxin in the brain Collaborations launched to evaluate gene therapy sequential dosing following treatment with LX2006 and explore cerebellar targeting to optimize outcomes in FA associated
MediWound Awarded Additional $3.3 Million from U.S. Department of War to Advance Room-Temperature-Stable Formulation of NexoBrid ® Award raises the total program budget to $21.8 million and supports development through Investigational New Drug (IND) submission for battlefield burn care YAVNE,
Best-in-disease results showed rapid, profound, sustained efficacy, supporting barzolvolimab’s potential to be a transformational therapy in CSU EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12 weeks across both studies and both dose groups Clinically meaningful and
In HYPERION, in patients diagnosed with PAH in the last 12 months, adding WINREVAIR on top of background therapy reduced the risk of clinical worsening events compared to placebo, informing the use of WINREVAIR earlier in the treatment journey Newly published European Respiratory Society (ERS) clinical guidelines provide updated evidence-based...
RNS Number: 6717V PureTech Health PLC 22 September 2026 22 September 2026 PureTech Health plc - Half-Year Report Delivered significant progress across the portfolio, including Seaport's Nasdaq IPO, Celea's financing and Phase 3 trial initiation, and Gallop's positive Phase 1b data, successful
At the highest dose (24 mg), enicepatide achieved a mean HbA1c reduction of 2.65% at 48 weeks, highlighting its potential for best-in-disease glycemic control In patients with poor baseline glycemic control (HbA1c >8.5%), enicepatide 24 mg led to an HbA1c reduction of 4.13% at 48 weeks By week 48, 90% of patients in the 24 mg enicepatide arm met the T2D...