Capricor Therapeutics (NASDAQ:CAPR) shares dropped after the U.S. FDA inspected its San Diego manufacturing facility for the ...

Shares of Capricor Therapeutics (CAPR) were in the spotlight on Wednesday morning after the company announced the completion ...

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in ...

Capricor Therapeutics, Inc. (NASDAQ:CAPR) announced today that it intends to file a Biologics License Application [BLA] for deramiocel for the treatment of patients with Duchenne Muscular ...

Capricor Therapeutics has submitted a Biologics License Application (BLA) to the FDA for deramiocel, an investigational cell therapy intended to treat Duchenne muscular dystrophy (DMD ...

In male patients with DMD, treatment with deramiocel reduced upper limb function deterioration compared with placebo. The Food and Drug Administration (FDA) has granted Priority Review to the ...

Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San ...

The HOPE-2 OLE study continues to show a favorable safety profile for long-term treatment of deramiocel. These data will be shared at this year’s Parent Project Muscular Dystrophy (PPMD ...

U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensure Advisory Committee meeting scheduled for July 30, 2025 Mid-cycle ...

“The successful completion of our mid-cycle review meeting along with the upcoming advisory committee meeting represents major milestones on the path towards approval of deramiocel,” said ...

With the FDA Advisory Committee meeting now scheduled, we look forward to the opportunity to present the totality of evidence supporting the approval of Deramiocel for the treatment of Duchenne ...