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Daily Roundup | Zenbexus Approval Tests a New Endpoint: What BMS Still Owes the FDA
Published 1 month ago
Description
BMS won FDA accelerated approval for Zenbexus on a 41% versus 21% MRD-negative complete response — with no survival data required. We break down what the first CELMoD approval means for Bristol Myers' Revlimid replacement strategy, why the CD38-pretreated label limit caps the launch, and the confirmatory readout still owed. Plus Capricor's 71% surge on a refined deramiocel filing in Duchenne muscular dystrophy, Taiho and Cullinan's early-stopped Phase 3 for zipalertinib in EGFR exon 20 lung cancer, and the Skye–Redx reverse merger creating Fibrx Therapeutics with $125 million for fibrostenotic Crohn's. Visit us at thepharmacloseout.com.