AllSci News
Ray Therapeutics’ RTx-015 optogenetic gene therapy earns RMAT designation for retinitis pigmentosa
Ray Therapeutics, a clinical-stage biopharmaceutical company headquartered in Berkeley, California, has announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT)…
FDA extends review of Orca Bio's Orca-T for hematologic malignancies to July 2026
Orca Bio has announced that the US FDA extended the review timeline for its Biologics License Application (BLA) for Orca-T, an investigational allogeneic...
Nuvation Bio takes global control of IDH1 drug safusidenib through Japan market deal with Daiichi Sankyo
Safusidenib, an oral brain-penetrant inhibitor of mutant IDH1, will now advance under a single global rights holder after Nuvation Bio (NYSE: NUVB) amended...
Pasithea’s PAS-004 MEK inhibitor receives FDA Fast Track designation for neurofibromatosis type 1
Pasithea Therapeutics Corp. (Nasdaq: KTTA), headquartered in Miami, Florida, has announced receipt of FDA Fast Track Designation for PAS-004, a macrocyclic small-molecule…
Axsome acquires Takeda's oral PDE10A inhibitor balipodect for neuropsychiatric disorders
Balipodect, an oral selective phosphodiesterase 10A inhibitor originally developed by Takeda Pharmaceutical (NYSE: TAK) as TAK-063, has changed hands in an...
Biocytogen's to support Sihuan Pharma on weight management antibodies
Biocytogen's RenMice platform anchors a strategic partnership with Sihuan Pharmaceutical Holdings Group (HKEX: 0460) that will direct fully human antibody...
Gan & Lee's once-weekly basal insulin beats insulin glargine and degludec in Phase III type 2 diabetes trials
Gan & Lee Pharmaceuticals (SSE: 603087) reported that its investigational once-weekly basal insulin analog, GZR4, met the primary endpoint of superior HbA1c...
Korsana to enter Nasdaq via USD 380m Cyclerion reverse merger
Cyclerion Therapeutics Executes Reverse Merger to Access Public Markets for Korsana Biosciences' THETA™ BBB-Shuttle Platform
Frontier Medicines hands LG Chem license to first-in-class p53 Y220C activator
FMC-220, a covalent small molecule described by Frontier Medicines as a first-in-class activator of the p53 Y220C mutant protein, is the subject of an...
Janux and Bristol Myers Squibb advance tumor-activated T cell engager, triggering USD 35m milestone
A tumor-activated T cell engager generated by Janux Therapeutics (NASDAQ: JANX) using its proprietary TRACTr platform has reached development candidate...
FDA approves Vertex’s Alyftrek and Trikafta label extensions for cystic fibrosis treatment
Vertex Pharmaceuticals has received US FDA approval for label extensions of both Alyftrek (vanzacaftor/tezacaftor/ivacaftor) and Trikafta (elexacaftor/tezacaftor/ivacaftor), expanding access to cystic fibrosis…
Landmark Bio picks up USD 18.3m ARPA-H award for extracellular vesicle manufacturing platform
Watertown, Mass.-based Landmark Bio has secured an ARPA-H award of up to USD 18.3 million to develop a continuous manufacturing platform for extracellular...
Enveda's oral atopic dermatitis candidate shows 85% EASI reduction in early trial
Enveda, the Boulder, Colo.-based biotechnology company, reported Phase 1b results for ENV-294 in moderate-to-severe atopic dermatitis, with interim findings...
Merck boosts antibody discovery capability through USD 838m partnership with Infinimmune
Infinimmune's Anthrobody® platform has drawn Merck (NYSE: MRK) into a multi-target antibody discovery collaboration structured around human immune...
OpenProtein.AI, Boehringer Ingelheim expand AI discovery partnership
OpenProtein.AI, a New York-based provider of AI-driven protein engineering software, and Boehringer Ingelheim, the privately held German pharmaceutical company, announced an expansion…
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