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.
Company receives third Breakthrough Therapy Designation for RASONQUE and fifth across its portfolio of RAS(ON) inhibitors, further highlighting its differentiated strategy for developing innovative medicines for patients with RAS-addicted cancers REDWOOD CITY, Calif., Sept.
Phase 2 MOONLIGHT-1 trial did not meet its primary efficacy endpoint Analyses of the data, including prespecified exploratory endpoints, are ongoing SAN DIEGO --(BUSINESS WIRE)--Sep. 14, 2026-- Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage
Post hoc analyses of SION-719 PreciSION CF subset showed a mean placebo-adjusted sweat chloride reduction of up to -8.6 mmol/L consistent with NBD1 biological activity Dual combination Phase 2a trial expected to initiate in first quarter of 2027 46% workforce reduction and other cost-saving
Ameluz used in conjunction with the RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, creating an additional growth opportunity for Biofrontera’s photodynamic therapy platform WOBURN, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE...
Update Supports Broader Access to IMDELLTRA in Community Settings for People Living with Extensive-Stage Small Cell Lung Cancer THOUSAND OAKS, Calif., Sept. 14, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the
Under the terms of the Amendment, all disputed issues are resolved SAN DIEGO and NERVIANO, Italy, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (NASDAQ: CRDF) ("Cardiff") and Nerviano Medical Sciences S.r.l. ("NMS") today announced that they have reached a settlement and amended their
RMAT Designation Supported by Positive Interim Data from RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 which Demonstrated Reduced Arrhythmia Burden Additional Data and Updates on Regulatory Discussions Anticipated in 4Q 2026 SOUTH SAN FRANCISCO, Calif., Sept.
Autoimmune diseases are characterized by high unmet medical need with most current treatments only addressing symptoms. Evaxion will apply AI-Immunology™ to target underlying pathologies The unique capabilities of AI-Immunology™ could potentially help develop new treatments with higher efficacy and
Open-label Phase 2 trial evaluating ebribafusp for the treatment of IgA nephropathy, lupus nephritis and C3 glomerulopathy Initial data is expected in 2027 WALTHAM, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics ®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to
Independent DSMB Recommends MediWound’s EscharEx ® Phase III VALUE Study Continue Without Modification DSMB did not identify safety concerns in pre-specified review; interim assessment and enrollment completion remain on track for end of the first quarter of 2027 YAVNE, Israel, September 14, 2026
SOUTH SAN FRANCISCO, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that members of its senior
Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the “dark genome” of all people. K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the
Company to host a virtual event today at 8:00 a.m. ET CAMBRIDGE, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases
Company Proposes Planned Phase 2b Neoadjuvant Study Following Successful Completion of Phase 1b Trial King of Prussia, Pennsylvania--(Newsfile Corp. - September 14, 2026) - Phio Pharmaceuticals Corp. (NASDAQ:...