Capricor Therapeutics Stock Jumps As FDA Resumes Deramiocel Review

Capricor Therapeutics Inc (NASDAQ:CAPR) shares are trading higher Tuesday morning after the biotech company said the U.S. Food and Drug Administration resumed its review of the Biologics License Application for Deramiocel, its experimental treatment for Duchenne muscular dystrophy cardiomyopathy, and assigned a new PDUFA target action date of August 22, 2026.

Here’s what investors need to know.

• Capricor Therapeutics shares are powering higher. What’s fueling CAPR momentum?

FDA Lifts Complete Response Letter After HOPE-3 Resubmission

The FDA had previously issued a Complete Response Letter in July 2025, but Capricor said the agency has now lifted that decision following the company's submission of data and supporting documentation from its HOPE-3 Phase 3 trial. The filing was classified as a Class 2 resubmission.

Capricor said Deramiocel showed positive pivotal HOPE-3 results, including achievement of the primary endpoint and all Type I error-controlled secondary endpoints.

The company added that the therapy has the potential to become the first treatment aimed at both the skeletal and cardiac complications of Duchenne muscular dystrophy, a rare genetic disorder that progressively weakens muscle function and often leads to heart failure.

The company also said it expects to be eligible for a Priority Review Voucher if Deramiocel is approved. CEO Linda Marbán said the FDA's action reflects acknowledgment of Capricor's response and supports continued review of the application.

CAPR Stock Momentum Signals Strong Bullish Trend

Capricor Therapeutics shares climbed from a 52-week low of $4.60 in early December 2025 to about $35.80 by early March 2026, marking a sharp rally and putting the stock near its 52-week high.

The price is trading well above its 20-day, 50-day and 200-day moving averages, a bullish setup that suggests strong momentum and continued investor interest in CAPR stock.

Benzinga Edge Rankings

Benzinga’s Edge Rankings show Momentum as the strongest category for CAPR at 98.75/100. To see how CAPR stock ranks for Value, Growth, Momentum, click here.

CAPR Shares Surge Tuesday Morning

CAPR Price Action: Capricor Therapeutics shares were up 17.21% at $35.90 at the time of publication on Tuesday, according to Benzinga Pro data.

Image: Shutterstock

This article Capricor Therapeutics Stock Jumps As FDA Resumes Deramiocel Review originally appeared on Benzinga.com