Replimune REPL RP1 melanoma
BriaCell’s FDA Clearance for Bria-PROS+ Adds a Fourth Active Immunotherapy
BriaCell just added a fourth active immunotherapy program to a pipeline that already has one candidate in Phase 3. The FDA didn’t blink. Two names covered here last week did get their answers this week, and the answers landed nothing alike, one company watched its stock double, the other is now talking about suing its…
FDA Panel Votes Down Capricor’s Deramiocel 9-3 for Duchenne Cardiomyopathy
Nine advisory committee members voted against Capricor’s Duchenne muscular dystrophy therapy on Tuesday. Three voted for it. The FDA’s own briefing document had called the primary evidence unconvincing before a single panelist spoke, and a nearly identical scene is playing out for a different company on the same regulatory stage today. Altimmune, meanwhile, needed no…
