FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026 Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositis If approved, brepocitinib would represent the first targeted therapy approved for dermatomyositis March 03, 2026 -- Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Applic

Extension financing adds new investors, Janus Henderson Investors and RA Capital, with strong renewed participation from existing investors Proceeds will support further clinical development of lead program PHB-050 in food allergy and other atopic conditions Phase 1 clinical trial for PHB-050 remains on track Poplar Therapeutics, Inc., a clinical-stage immunology company developing a new class of anti-IgE therapy to treat food allergy and other atopic conditions, today announced the closing o

Sinopia Biosciences, Inc., a biotechnology company advancing novel therapeutics discovered using its proprietary LEADS® (LEarn And DiScover) drug discovery platform, today announced a target discovery collaboration with Ono Pharmaceutical Co., Ltd. focused on an undisclosed group of rare metabolic disorders with significant unmet medical need. Under the agreement, Sinopia will apply its proprietary metabolomics-driven discovery platform to identify and validate novel therapeutic targets aimed a

An investigational medicine that addresses the genetic root cause of BAG3 DCM, AFTX-201 is being evaluated in the UPBEAT© clinical trial AFTX-201 is designed using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies

Substantial clinical evidence provides rationale to initiate Phase 2 study in PV Phase 2 study expected to begin 3Q26 with potential for data readouts as early as 4Q26 and throughout 2027 AN2 to host webcast on Wednesday, March 4, 2026 at 9:30am ET/ 6:30am PT AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today announced its plans to expand the development of oral epetrabor

March 3, 2026 -- Linus Health will present new research at a leading global Alzheimer's and Parkinson's Diseases conference, revealing how advanced insights from digital cognitive assessments and personalized outcome measures may help transform how patients are identified for emerging therapies and how treatment impact is measured in ways that reflect patients' personal priorities. This research will be presented at the International Conference on Alzheimer's and Parkinson's Diseases and Relate

March 03, 2026 -- Persevere Therapeutics, Inc. (“Persevere”), a Delaware-incorporated, clinical-stage oncology biotechnology company, today announced its official launch following a period of stealth operations. The company is emerging with a Phase 1b/2a-ready clinical asset and the first close of its Seed financing. As part of its launch, Persevere has acquired the clinical-stage program and related assets for misetionamide (GP-2250) from Geistlich Pharma AG. Misetionamide is a novel, first-i

Syntis Bio, Inc. a clinical-stage biopharmaceutical company advancing novel oral therapeutics that uniquely leverage the small intestine, today announced that the first patient has been dosed in the Phase 1/1b SYNTIETY-1 clinical trial of SYNT-101, the company’s lead investigational program for the treatment of obesity. SYNT-101 is designed as a once-daily oral pill that redirects nutrient absorption past the small intestine’s duodenum, mimicking the effects of gastric bypass surgery. "Dosing o

March 3, 2026 -- On March 2, 2026, Pierre Fabre Pharmaceuticals, Inc., submitted a request to the U.S. Food and Drug Administration (FDA) for a Type A meeting on the biologic license application for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for relapsed/refractory Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD), to address the January 9, 2026 Complete Response Letter from the agency. "We look forward to meeting with the agency to

Initial $50M Series A investment from founding investor RTW Investments Proceeds will fund clinical development of PRO-203 in systemic sclerosis (SSc) and multiple additional severe autoimmune diseases March 03, 2026 -- Prolium Bioscience, Inc. (Prolium), a clinical stage biotechnology company, today announced its launch with a $50 million Series A Financing to develop PRO-203, a potential best-in-class CD20xCD3 T-cell engager, for severe autoimmune disease. The financing was led by its foundin