Pfizer’s PD-1 inhibitor hits endpoint in BCG-naïve bladder cancer

Though Pfizer Inc.’s work on a PD-1-targeting antibody has trailed far behind that of its fellow big pharmas, the company could be the first to market in treatment-naïve, high-risk non-muscle invasive bladder cancer (NMIBC) on the back of solid phase III data showing subcutaneously administered sasanlimab hit its endpoint of event-free survival. Pfizer anticipates meeting with regulatory agencies to discuss potential filings for what could be the first new treatment for that NMIBC population in decades.

Dyne seeks accelerated path on positive dystrophy data; shares down

Dyne Therapeutics Inc. is eyeing accelerated approval for its myotonic…