Shares of Capricor Therapeutics lost nearly two-thirds of their value Monday after Food and Drug Administration documents raised the specter of another rejection of the company's proposed cell therapy for Duchenne muscular dystrophy, or DMD.

Capricor shares were recently down 63% to $7.28.

The FDA, which is slated to hold an advisory committee meeting Wednesday to discuss Capricor's deramiocel for the treatment of cardiomyopathy associated with DMD, released briefing documents ahead of the meeting that shows the agency believes Capricor's data doesn't provide substantial evidence of the cell therapy's effectiveness.

The FDA last July rejected Capricor's initial deramiocel application, saying it hadn't met the statutory requirement for substantial evidence of effectiveness, and the company resubmitted the application late last year with additional data from a Phase 3 study.

The FDA in March said it would again review deramiocel, with a target action date of Aug. 22, and last month said it would hold the advisory committee meeting.

The FDA often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective.

In the briefing documents for the meeting released Monday, the FDA said its reviewers were unable to identify a DMD subpopulation that may potentially derive benefit from deramiocel after extensive analyses of the data in the original application and the resubmission, adding that "the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness."

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 27, 2026 10:33 ET (14:33 GMT)

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