Capricor Therapeutics, Inc. - Common Stock (CAPR)

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.

The FDA has indicated that an advisory committee meeting is not required at this time, the company said, while adding that its application for Deramiocel approval remains under priority review.

Capricor stock drops as FDA cancels advisory meeting on Duchenne therapy; leadership changes and regulatory tensions fuel uncertainty.

Capricor shares four-year data showing Deramiocel slowed DMD progression and preserved function, with maintained safety in long-term use.

Stay up-to-date with the latest market trends one hour before the close of the markets on Friday. Explore the top gainers and losers during today's session in our detailed report.

Capricor on Friday announced positive four-year safety and efficacy results from its ongoing mid-stage study of its cell therapy Deramiocel, which failed to cheer investors.

The session on Friday is off to an intriguing start with several stocks showing significant price gaps. Let's examine the gap up and gap down stocks in today's session.

Capricor expressed confidence that the facility will meet the necessary requirements to support product licensure and commercial launch, pending approval.

FDA names Vinay Prasad to lead CBER, raising questions over biologics oversight and triggering biotech stock losses and analyst concerns.

The U.S. FDA stated that its review committee has identified no significant deficiencies and is on track to make a decision on the application by its deadline of the end of August.

If CAP-1002 (Deramiocel) is approved on schedule, deramiocel would become the first therapy indicated specifically for DMD-associated cardiomyopathy, addressing a critical unmet need. The StealthX(tm) exosome delivery system is a momentous change.

Don't be scared off up by the recent Trump FDA overhaul. The changes are very positive for Capricor Therapeutics moving forward (2025–2028).

U.S. stock futures were lower this morning, with the Dow futures falling more than 250 points on Monday.

The company said its available cash, cash equivalents, and marketable securities will be sufficient to cover the expenses and capital requirements into 2027.