FAYUVI is a highly anticipated, first-ever treatment option with the potential to stop or slow the devastating, irreversible neurologic progression and loss of function associated with Sanfilippo syndrome Type A Ultragenyx’s UltraCare® program will support access, and commercial product is expected
The center will be a hub for Roche and Genentech, bringing together expertise in Cardiovascular, Renal and Metabolism, as well as for data science and AI specialists to drive innovation in drug discovery and development It will expand Roche’s and Genentech’s presence in Boston, reflecting a long-term commitment to one of the world’s leading life sciences...
Combined company to focus on developing first-in-class next-generation medicines for cardioendocrine diseases Marea has multiple late-stage clinical product candidates: MAR001/005 for severe hypertriglyceridemia (sHTG) currently in Phase 2b and MAR002 for the treatment of acromegaly which is
KELOWNA, BC / ACCESS Newswire / September 17, 2026 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms is providing the following update....
Last patient has completed the last scheduled study visit in the pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome Top-line results remain on track for late November 2026 NESS ZIONA, Israel, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd.
Chief Commercial Officer Bryan Downey Joins Panel Discussion on Reinventing the Launch Playbook for Small and Mid-Size Pharma KANSAS CITY, Kan., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™)
Cash redemption simplifies the capital structure with no common shares issued in the redemption CALABASAS, Calif., Sept. 17, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing
~ Primary Endpoint Met: American Speech-Language-Hearing Association (ASHA)-Defined Hearing Loss Occurred in 24.0% of Patients Versus the Prespecified Historical Benchmark of 56.4% (P=0.001) ~ ~ 84% of Patients Had Grade 0 Hearing Loss by Brock Criteria; No Grade 3 or Grade 4 Hearing Loss Was
Resubmission supported by positive topline human factors and pharmacokinetic (PK) study results announced in August 2026 FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission WARREN, N.J., Sept.
BOSTON, Sept. 17, 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,
NEW YORK, Sept. 17, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced presentations of new data in major depressive disorder and Alzheimer’s disease agitation
Phase III CELESTIMO study met its primary endpoint at the interim analysis demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression in people with follicular lymphoma who have received at least one prior line of treatment Data reinforce the potential of this Lunsumio-based regimen to improve clinical...
MENLO PARK, Calif. --(BUSINESS WIRE)--Sep. 16, 2026-- AN2 Therapeutics, Inc. (NASDAQ: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today announced it granted inducement equity awards to Cameron Trenor,
Cambridge, Mass.— Biogen Inc. (Nasdaq: BIIB) today announced it will report third quarter 2026 financial results Wednesday, October 28, 2026, before the financial markets open. Following the release of the financials, the Company will host a live webcast with Biogen management at 8:30 a.m. ET.
BRISBANE, Calif., Sept. 16, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced that it has granted
CEO Amir Heshmatpour has purchased 111,000 shares for approximately $418,700 since the Company announced positive NEO100 Phase 2a results CALABASAS, Calif., Sept. 16, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage
WATERTOWN, Mass., Sept. 16, 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
SAN DIEGO, Sept. 16, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disease,
DUBLIN --(BUSINESS WIRE)--Sep. 16, 2026-- Alkermes plc (Nasdaq: ALKS) today announced the appointment of a new independent director, Anne C. Whitaker, to the company’s Board of Directors (the Board). Ms. Whitaker is a seasoned biopharmaceutical executive and experienced board director who brings
Approval Addresses High Unmet Medical Need and Further Advances Viatris' Innovative Portfolio in Japan PITTSBURGH, Sept. 16, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare has granted approval for
The First and Only Anti-Amyloid Treatment in Japan that Enable At-Home Administration for Alzheimer's Disease, a Progressive Disease TOKYO and CAMBRIDGE, Mass., Sept. 16, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that “LEQEMBI ® Pen”, the subcutaneous
NEW YORK, NY, and WASHINGTON, DC, September 15, 2026 — Royalty Pharma and Blood Cancer United today announced a $7.5 million donation from Royalty Pharma to support Blood Cancer United’s Therapy Acceleration Program (TAP), a collaborative venture philanthropy initiative designed to accelerate the development of promising blood cancer therapies through...
-Transaction complements Tempest’s existing CD7-targeted lipid nanoparticle in vivo CAR-T delivery platform, which is planned to enter the clinic later this year -Lead BCMA/GPRC5D dual-targeting in vivo CAR-T candidate is in Phase 1 dose escalation for relapsed/refractory multiple myeloma -Early
HIGH POINT, N.C., Sept. 15, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company focused on the development of cadisegliatin, a novel, potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1
Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment. FDA has revised the Generic Drugs User Fee Act (GDUFA) Goal Date to November 10, 2026. WILMINGTON, Del., Sept.
GSK announced it has entered an agreement to acquire a potential best-in-class trispecific T cell-engager from Chimagen Biosciences.
15 September 2026 Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announced that, on 14 September 2026, Dr Aradhana Sarin, Chief Financial Officer of the Company, acquired 73 of the Company's ordinary shares of $0.25 each (Ordinary Shares) following the vesting of certain dividend equivalent awards accrued in...
15 September 2026 Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announces that it was notified on 14 September 2026 that Michel Demaré, Non-Executive Chair of the Board, purchased 2,500 of the Company's ordinary shares of $0.25 each (Ordinary Shares) on 14 September 2026, as set out below....
Investment led by Clene’s Chairman of the Board of Directors, alongside founding investor Kensington Capital Holdings, Clene’s Chief Executive Officer and other existing shareholders $4 million registered direct offering priced at market under Nasdaq rules Proceeds are expected to be sufficient to
Acquisition adds ABS-1230, a clinical-stage, potential first-in-class precision therapy for KCNT1-related epilepsy Transaction strengthens Jazz's epilepsy pipeline and reinforces its commitment to advance treatment options in rare disease DUBLIN, Sept.
Reverse split approved at April 2026 Special Meeting of StockholdersShares of Jaguar Health common stock to begin trading on split-adjusted basis on September 17, 2026 Reverse split approved at April 2026 Special Meeting of Stockholders Shares of Jaguar Health common stock to begin trading on
PETACH TIKVA, Israel, Sept. 15, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that senior management
NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set for June 29, 2027 WALTHAM, Mass. and BOULDER, Colo., Sept.
- Vonn shares her experience using JOURNAVX to manage her acute pain after a career-altering injury at the 2026 Winter Games - BOSTON --(BUSINESS WIRE)--Sep. 15, 2026-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the company has partnered with world champion skier
- ARO-DIMER-PA achieved deep and durable silencing of two genes with a single RNAi molecule - Mean maximal single dose reductions in serum PCSK9 of 72% and APOC3 of 88% - Clinical validation further demonstrates Arrowhead’s position as the leading innovator in siRNA therapies - PASADENA, Calif.
Consistent with prior Type C Meeting, the Pre-NDA Meeting confirms Ocular’s plan to submit AXPAXLI NDA based on SOL-1 Week 52 efficacy and safety, interim SOL-R safety, and confirmatory evidence AXPAXLI NDA submission for wet AMD remains on track for 4Q 2026 NDA submission to include subjects that
– Rademikibart meaningfully reduced the rate of treatment failure at 28 days by 66% compared to placebo – –Rademikibart produced a rapid, statistically significant improvement in lung function at Day 7 compared to placebo – – Rademikibart was well tolerated in asthma patients experiencing an acute
Pivotal results from TRIUMPH-2 showed retatrutide, an investigational triple hormone receptor agonist, delivered substantial weight loss and A1C improvements in obesity and type 2 diabetes Findings from ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes, reaffirmed its safety
TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, met all prespecified endpoints, including unprecedented placebo-adjusted estimated glomerular filtration rate (eGFR) and composite kidney disease progression benefits. Favorable safety profile, and generally comparable to placebo.
COPENHAGEN, Denmark, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that its Board of Directors has authorized the Company to repurchase up to $400 million of the Company’s ordinary shares (the Share Repurchase Program).
- All rights to TransCon technology-based products in metabolic and cardiovascular diseases, including once-monthly TransCon Semaglutide, will revert to Ascendis - Ascendis to initiate multiple programs in metabolic and cardiovascular diseases, including obesity COPENHAGEN, Denmark, Sept.