Why Is Capricor Therapeutics Stock Trading Lower On Friday? - Capricor Therapeutics (NASDAQ:CAPR)

Capricor: Further Value Unlocked With Priority Review Of Deramiocel (NASDAQ:CAPR)

FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease

Capricor Therapeutics said the FDA asked for more data supporting the efficacy of Deramiocel, the biotech’s off-the-shelf cell therapy for treating the heart complications of Duchenne muscular dystrophy. Those data could come from an ongoing Phase 3 study expected to yield preliminary results soon. The post FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease appeared first on MedCity News.

Capricor Therapeutics Hammered On A Surprise FDA Rejection

FDA rejects Capricor's cell therapy for Duchenne muscular dystrophy

The company had submitted data from a study that yielded mixed results, the kind of case that can be a flashpoint for regulatory controversy.

FDA turns back Capricor’s Duchenne cell therapy

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the agency during deramiocel’s review.

Why Is Capricor Therapeutics Stock Trading Lower On Friday? - Capricor Therapeutics (NASDAQ:CAPR)

Capricor Therapeutics Inc. (NASDAQ:CAPR) stock is trading lower on Friday. The company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In the CRL, the FDA stated that it had completed its application review but could not approve…