Capricor Therapeutics (CAPR) stock dove on Friday after the biotechnology company revealed a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). This letter covered its Biologics License Application (BLA) for Deramiocel, a cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). That’s a severe genetic disorder that causes progressive muscle weakness and degeneration.
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The big news here is that the FDA completed its review of the BLA for Deramiocel and has rejected the therapy in its current form. The FDA said it “does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.” The FDA is willing to restart its review with additional data and has granted Capricor Therapeutics a Type A meeting to discuss further action.
Capricor Therapeutics CEO Linda Marbán noted that the CRL from the FDA was a surprise. She claimed that the company followed the FDA’s guidance throughout the submission process and that no issues were revealed ahead of the CRL. She said the company will “submit data from the Phase 3 HOPE-3 clinical trial to provide additional evidence of effectiveness from an adequate and well-controlled study.”
Capricor Therapeutics Stock Movement Today
CAPR stock was down 38.51% in pre-market trading on Friday, following a slight 0.18% dip yesterday. The shares were also down 17.39% year to date, but remained up 159.09% over the past 12 months. Today’s news triggered a stock selloff, with some 4 million shares traded this morning, compared to a three-month daily average of about 2.59 million units.
Is Capricor Therapeutics Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Capricor Therapeutics is Strong Buy, based on nine Buy and one Hold rating over the past three months. With that comes an average CAPR stock price target of $30.60, representing a potential 167.42% upside for the shares.
