Negative FDA briefing docs for July 29 AdCom trigger CAPR plunge
- FDA states HOPE-3 trial failed prespecified primary/secondary efficacy endpoints vs placebo at 12 months
- Agency flags multiple post-hoc changes to statistical analysis plan, including endpoints and imputation methods
- Additional analyses submitted without FDA-reviewed/approved updated SAP, raising data integrity concerns
- Briefing materials released ahead of July 29 CTGTAC meeting; PDUFA target remains Aug 22 2026
- Stock plunged ~62% in premarket on July 27 from prior close near $19.70, per market data
- Earlier company presentations of positive 5-year HOPE-2 OLE and HOPE-3 data contrasted with FDA critique
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