CAPR Stock Dips Huge: Deramiocel Missed Primary & Secondary Endpoints
The FDA on Monday released briefing documents ahead of a July 29 meeting of its Cellular, Tissue, and Gene Therapies Advisory Committee. In the documents, FDA reviewers said the study failed to meet its pre-specified primary and secondary efficacy endpoints, finding no statistically significant difference between Deramiocel and placebo after 12 months. - https://www.tradingview.com/news/stoc... Negative FDA briefing docs for July 29 AdCom trigger CAPR's 62% premarket plunge. FDA states HOPE-3 trial failed pre-specified 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. - https://finviz.com/stock?t=CAPR&p=d Join this channel to get access to perks: / @equity4keeps Consider Supporting this Channel via PayPal: https://www.paypal.com/donate/?hosted... Is CAPR a good stock to buy? What is the CAPR stock forecast for 2025? What does Capricor Therapeutics do? Capr stock price prediction, Capr Stocktwits, Capr stock news; Why is CAPR stock dropping? CAPR stock price target, Capr yahoo finance, CAPR news, Capricor Therapeutics.