FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy ...

Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly muscle disorder.

In total, 11 abstracts on givinostat were accepted for presentation at the Congress, including two for an oral presentation ...

Capricor Therapeutics shares plummeted in premarket trading Friday after the U.S. Food and Drug Administration turned away the biotechnology company's bid for approval of Deramiocel, its lead ...

Families caring for individuals with Duchenne muscular dystrophy (DMD) face significant financial burdens from necessary home ...

Capricor, which was seeking approval of Deramiocel for the treatment of cardiomyopathy associated with DMD, said the FDA issued a so-called complete response letter, indicating the agency won't ...

Investing.com -- Capricor Therapeutics (NASDAQ: CAPR) stock plunged 53% after the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) rejecting its ...

Taiho Pharmaceutical has suffered a blow to its near-term pipeline after a drug candidate for Duchenne muscular dystrophy ...

Taiho-developed TAS-205 is designed to selectively inhibit hematopoietic prostaglandin D synthase (HPGDS), an enzyme related ...

Sarepta Therapeutics Inc. misled investors about the safety and prospects for one of its Duchenne muscular dystrophy ...