FDA Decision Watch: BMY, EGTX Await Key Rulings As BFRI, SRRK, MIRM Win Early Approvals
Bristol Myers Squibb (BMY) and Egetis Therapeutics (EGTX) await FDA decisions on drug expansions. Biofrontera (BFRI), Scholar Rock (SRRK), and Mirum Pharmaceuticals (MIRM) received early approvals. BMY's Camzyos, if approved, would be the first cardiac myosin inhibitor for adolescents with oHCM. EGTX's Emcitate could be the first FDA-approved treatment for MCT8 deficiency. SRRK and BFRI shares declined post-approval, while MIRM shares rose.
