Two phase III studies of setrusumab, Orbit and Cosmic, for treating brittle bones have failed and left the developers floundering on Wall Street. Neither of Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc’s studies of the monoclonal antibody in treating osteogenesis imperfecta hit statistical significance in their primary endpoints, though they did achieve their secondary endpoints. The companies are still looking at the numbers to determine their next steps.
In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity. As has become typical for the scientific Nobel Prizes, the award-winning research is by now several decades old. But the discoveries were the basis for ongoing research into how to prevent autoimmunity that notched significant wins in 2025, in both basic research and in the clinic.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Amneal, Formycon, Invivyd, Mannkind, Novo Nordisk, Reviva, Samsung Bioepis, Regeneron, Sanofi, Zai Lab.
Biopharma happenings, including deals and partnerships, and other news in brief: Bioeq, Cassava, Dexcel, GSK, Orexo, Samsung Biologics, Seismic, Vaccinex, Windtree, Zydus.