FDA lifeline for Capricor as deramiocel filing pivots to upper-limb claim
US biotech firm Capricor Therapeutics (Nasdaq: CAPR) has won a reprieve for its Duchenne muscular dystrophy (DMD) cell therapy deramiocel, telling investors the FDA is prepared to consider an amended filing built around upper-limb muscle function rather than the cardiac claim rejected by an advisory panel last month.
Chief executive Linda Marbán said on the company's second-quarter earnings call on August 13 that Capricor plans to amend its biologics license application (BLA) with 24-month open-label extension data from the pivotal Phase III HOPE-3 trial, alongside fresh analyses of the existing data package.
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