Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Bio-Thera, Clearside, Dr. Reddy's, Galderma, Kiora, Neurim, Parvus, Stallergenes, Verastem.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cortice, CNS Pharmaceuticals, Leveragen, Moderna, Mthera, Neurobo, Neutherx, VBI Vaccines, Verseon.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aspargo, Biontech, Celldex, Clearside, Imunon, Nkgen, Novo Nordisk, Roche Holding, Yamo.
Radiopharm Theranostics Ltd. said it plans to list on Nasdaq by the end of 2024. The company had earlier announced plans to list in February 2023, but it delayed the listing due to market conditions.
Macrogenics Inc., agreeing with an independent data monitoring committee, has discontinued dosing patients in the troubled phase II Tamarack study of vobramitamab duocarmazine as a second-line treatment for metastatic castration-resistant prostate cancer.
The disappointments continue for Fibrogen Inc., which is terminating work on its once-promising anti-CTGF monoclonal antibody, pamrevlumab, after reporting missed endpoints in two late-stage pancreatic cancer studies, and cutting its workforce by about 75%.
Zevra Therapeutics Inc. will make its case Aug. 2 for its Niemann-Pick type C (NPC) candidate, arimoclomol, when the U.S. FDA’s Genetic Metabolic Diseases Advisory Committee (GeMDAC) meets for the first time.
Pepgen Inc. fell slightly short of its phase II dystrophin goal with PGN-EDO51 for patients with Duchenne muscular dystrophy (DMD) whose mutations are amenable to an exon 51-skipping approach, but Wall Street reacted in a big way, sending the Boston-based firm’s stock (NASDAQ:PEPG) down 33%, or $5.55, to close July 31 at $11.43.
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