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Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...
Dyne Therapeutics, Inc. (NASDAQ:DYN) is one of the 13 Best Healthcare Stocks to Buy Under $10. In a report released on July 7 ...
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...
The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.
US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug ...
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Asianet Newsable on MSNCapricor Stock Plunges Pre-Market After US FDA Declines Approval For Muscular Disorder TherapyThe FDA told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does ...
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The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...
They said he wouldn’t make it this far. He’s proving them wrong -- one push at a time.” At just 16, Nathan Espina is defying ...
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Capricor Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The company’s CEO said ...
Solid Biosciences' DMD gene therapy shows promise with SGT-003 and strong cash backing through 2027. Click here to read an ...
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