FDA advisors have voted that Capricor Therapeutics has not provided strong evidence of efficacy for its cell therapy for muscle problems associated with Duchenne muscular dystrophy, putting its approval in doubt. Shares in Capricor lost two-thirds of their value after the FDA published the briefing document, and remained weak after the advisory committee vote, which makes the chances of an approval now very shaky. Capricor said it informed the FDA of the proposed changes last September, but received no feedback on the proposal before submitting its finalised application in November. The company's chief executive, Linda Marbán, pointed out that this is the same data considered by the FDA and its expert advisors. "We have continued to work with the FDA throughout its review, and we firmly believe this evidence supports approval," she said.