– Completion of BLA submission expected in Q4 2026 – Sept. 21, 2026 -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced that it completed the previously announced agreement with Sangamo Therapeutics, Inc. to acquire ST-920 – a BLA-stage, one-time administered AAV gene therapy for Fabry disease. A rolling BLA submission to FDA for accelerated approval of ST-920 is expected to be completed in Q4 2026. "Our team looks forward to completing the ST-920 BLA submission and potentially bringing

Iambic launched a larger version of its Enchant drug-discovery model on Monday alongside a multi-year agreement with AbbVie that will put the technology to work across immunology, neuroscience and oncology. The tie-up adds another large pharma partner to Iambic's portfolio just months after deals with Takeda and Bayer. "The goal of our collaboration with Iambic is to design better molecules more efficiently and improve our probability of success, ultimately to deliver breakthrough medicines for

NIH-supported research will evaluate the mechanistic effects of fosamprenavir and support a Phase II randomized, double-blind, placebo-controlled clinical trial in patients with PPI-refractory GERD N-Zyme Biomedical Inc. (“N-Zyme”), a clinical-stage biotechnology company developing novel pepsin-targeted therapies for reflux disease, today announced that a research team led by N-Zyme Co-Founder and Chief Scientific Officer Dr. Nikki Johnston has been awarded US$2.76 million through an R01 resear

Round Led by .406 Ventures Fuels Teal Health's Next Phase of Growth, Expanding Payor, Health System, Employer and Provider Partnerships Ahead of Broad Insurance Coverage in 2027 Sept. 22, 2026 -- Teal Health, creators of the Teal Wand™, the first and most accurate FDA-authorized self-collection device for at-home HPV cervical cancer screening, today announced $22 million in Series A funding to meet accelerating consumer demand and expand access ahead of broad insurance coverage beginning in Ja

Feedback from U.S. FDA supports advancement into Phase 2 STRIDE-MDS trial in patients with R/R HR-MDS First-in-class, mutation-agnostic approach has the potential to address a broad R/R HR-MDS population PureTech intends to secure external capital in the first half of 2027 to support the continued development of LYT-200 through its Founded Entity, Gallop Oncology PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to sc

Primary endpoint and the key secondary endpoint were met with high statistical significance and CUE-221 demonstrated an overall favorable safety profile Clinically different efficacy profile observed relative to XOLAIR® (omalizumab) highlights potential for a fundamental mechanism-based biological difference Cue Biopharma to host conference call on Monday, September 21, at 8:00 a.m. EDT Sept. 20, 2026 -- Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company targeting transfo

Lōkahi Therapeutics™, a subsidiary of Glucotrack, Inc. (Nasdaq: GCTK), today announced that The University of Alabama’s Culverhouse College of Business will continue its participation in the ai² Pipeline division for the upcoming academic year. The renewed collaboration extends a hands-on program in which students evaluate real-world biopharmaceutical business development and asset assessment opportunities. The program also supports Lōkahi’s strategy of identifying and evaluating promising thera

If approved, Cosentyx (secukinumab) will be first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica (PMR), providing new treatment option after steroids¹ Recommendation based on data showing Cosentyx doubled sustained remission rates and delivered steroid sparing effects vs placebo; safety was consistent with established Cosentyx profile² Despite being a common inflammatory rheumatic disease in people over 50, there are limited advanced treatments for PMR; extended use o

First and only approved treatment indicated for Ataxia-Telangiectasia (A-T) in the United States or anywhere in the world Second FDA-approved indication for AQNEURSA, following previous approval for Niemann-Pick disease type C (NPC) AQNEURSA is commercially available now AQNEURSA provides a long-awaited treatment option for patients living with A-T IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, tod

—sNDA Under Review for Full Approval Is Based on Positive Results From Phase 3b ENCORE Study— —Full Approval Could Bring ARIKAYCE to Patients Earlier in Their Disease Course and Would Fulfill Post-Marketing Requirement From FDA— Sept. 21, 2026 -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administr