Capricor Eyes RMAT Designation Based On Interim Phase II Data
Capricor reported positive interim Phase I/II results for its cell therapy designed to treat cardiomyopathy in DMD patients and said it plans to seek regenerative medicine advanced technology, breakthrough or both designations from the US FDA.
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Although only interim data from six treated patients, Capricor’s Phase II DMD study shows improvements in upper limb performance, grip strength and respiration. Cardiac performance shows positive trend, but not yet statistical significance.
The latest drug development news and highlights from our US FDA Performance Tracker.
California biotech says it will move forward with knowledge and expertise gained through the failed partnership. Capricor hopes to re-partner CAP-1002 for cardiovascular indications, while continuing the candidate’s DMD development itself.