While Spruce Biosciences Inc.’s tildacerfont missed its phase II primary endpoint in classic congenital adrenal hyperplasia (CAH) last March, the U.S. FDA approved Crenessity (crinecerfont) from Neurocrine Biosciences Inc. for treating pediatric and adult CAH patients. The nod could lead the drug to become a blockbuster, analysts said.
Newron Pharmaceuticals SpA scored €44 million (US$46.26 million) up front in a potential €117 million licensing deal with EA Pharma Co. Ltd. to pad the clinical runway of its late-stage oral schizophrenia asset, evenamide (NW-3509), sending company stock prices up near 20%.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boundless, EA Pharma, Editas, Elevation Oncology, Lakeshore, Newron.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actimed, Assertio, Bicycle, Corcept, Incyclix, Iteos, Jaguar, Repare.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Ascendis, Bridgebio, Eli Lilly, Galderma, Geron, Gilead, Merck, Roche, Sanofi.
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