- FDA disputes Capricor's claims of Phase 3 success for DMD cell therapyIn briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.BioSpace · 3h ago↗ source
- MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readoutWhile MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb's Cobenfy is likely to hold its market share.BioSpace · 3h ago↗ source
- Gossamer regains rights to lung disease asset from Chiesi after Phase 3 failDespite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.