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Capricor Therapeutics (NASDAQ:CAPR) said it has scaled up expanded capacity at its new manufacturing facility in San Diego in preparation for the anticipated launch of its cell therapy CAP-1002, with Cohort A Phase 3 data for the product expected in Q4.
Capricor said enrollment for Cohort B of the Phase 3 study is expected to be completed in Q2. The product is being tested in the treatment of Duchenne muscular dystrophy.
The biotech company added that it plans to meet with the FDA to discuss possible expedited pathways for approval.
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