Capricor shares jump after 24-month deramiocel data support revised FDA application

  • Capricor reported 24-month HOPE-3 results supporting deramiocel’s revised FDA application.
  • B. Riley raised Capricor’s price target to $21 from $5 and upgraded the stock to Buy.
  • Capricor narrowed deramiocel’s application toward preserving upper-limb function after the July advisory vote.

Shares of Capricor Therapeutics rose Wednesday after the company reported positive 24-month results from its pivotal Phase 3 HOPE-3 trial of deramiocel in Duchenne muscular dystrophy. The cell therapy slowed the decline of upper-limb function compared with placebo over the two-year evaluation, supporting Capricor’s amended Biologics License Application focused on preserving upper-limb function. The FDA’s target action date is November 22. The revised strategy follows a July FDA advisory committee vote against recommending deramiocel for DMD-related cardiomyopathy, although the FDA can reach a different decision. B. Riley upgraded Capricor to Buy from Neutral and raised its price target to $21 from $5. Capricor shares were up 11.79% at $9.59 at the time of publication, according to Benzinga Pro. The HOPE-3 results build on a 12-month analysis that showed a 54% reduction in upper-limb functional decline versus placebo, with p=0.03, and included 82 of 106 patients who completed 24 months of follow-up. Capricor continues to have no commercial product revenue and relies on financing and collaborative agreements, including its partnership with Nippon Shinyaku in Japan.

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