FDA minutes clear NDA path for seralutinib, driving GOSS up
FDA minutes clear NDA path for seralutinib, driving GOSS 28% premarket surge
- July 27 announcement: productive Pre-NDA Type B FDA meeting minutes received
- FDA views PROSERA Phase 3 data (narrow p=0.0320 miss) as review not filing issues
- Supports September 2026 NDA filing for PAH using Phase 3 + Phase 2 confirmatory data
- Potential FDA approval decision in Q3 2027 if accepted
- Reacquired full worldwide rights to seralutinib from Chiesi ($5M payment received)
- Significant debt reduction via note exchange approved; ~$57M cash as of June 30
- Provides regulatory clarity and full economics after earlier Phase 3 setback
- Stock reacted sharply to regained control and NDA timeline
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