FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting ...

Capricor on Tuesday disclosed that the FDA has indicated that no AdCom is necessary for deramiocel’s Biologics License ...

Capricor Therapeutics updates on Deramiocel BLA for duchenne muscular dystrophy: San Diego Thursday, June 26, 2025, 15:30 Hrs [IST] Capricor Therapeutics, a biotechnology company ...

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.

Deramiocel is an Investigational New Drug (IND) and is not yet approved for any indications. Neither BMD nor any of Capricor’s exosome-based candidates have been approved for clinical use.

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

Deramiocel is an Investigational New Drug (IND) and is not yet approved for any indications. Neither BMD nor any of Capricor’s exosome-based candidates have been approved for clinical use.

Deramiocel has demonstrated potential to treat the serious cardiac and skeletal muscle complications of Duchenne Muscular Dystrophy, and based on the overlap in disease pathology, may also offer ...

Deramiocel is currently in late-stage development for the treatment of Duchenne Muscular Dystrophy. Capricor is also harnessing the power of its exosome technology, using its proprietary StealthX™ ...