Promising Regulatory Progress and Upcoming Milestones Support Buy Rating for Capricor Therapeutics

Analyst Joseph Pantginis from H.C. Wainwright reiterated a Buy rating on Capricor Therapeutics (CAPR – Research Report) and keeping the price target at $77.00.

Joseph Pantginis has given his Buy rating due to a combination of factors that highlight the promising regulatory progress of Capricor Therapeutics. The FDA has completed its pre-license inspection of Capricor’s San Diego facility for Deramiocel, with only minor observations related to routine quality systems and documentation, which have already been addressed. Importantly, no significant changes were required for the facility, and the FDA was positive about the new facility and methods.
Furthermore, the upcoming Advisory Committee (AdCom) meeting, tentatively set for July 30, 2025, is seen as a crucial milestone for Capricor. This meeting will allow the company to demonstrate Deramiocel’s safety and efficacy, as well as the urgent need for new treatments for Duchenne muscular dystrophy. The recent mid-cycle review meeting with the FDA revealed no significant deficiencies, and the Biologics License Application remains under priority review with a PDUFA date of August 31, 2025. These developments collectively support the Buy rating, as they indicate strong potential for Deramiocel’s approval and commercial success.

In another report released on June 6, Oppenheimer also reiterated a Buy rating on the stock with a $43.00 price target.