Shares of Capricor Therapeutics Inc. (NASDAQ:CAPR) are trading higher Wednesday morning following the release of positive long-term clinical data for its lead cellular therapy. The rally provides critical support for the biotechnology firm as it attempts to salvage a regulatory approval following a recent advisory panel rejection.
Here’s what investors need to know.
- Capricor Therapeutics stock is charging ahead with explosive momentum. What’s fueling CAPR momentum?
HOPE-3 Data Backs Revised BLA Strategy
Late Tuesday, Capricor announced 24-month results from its pivotal Phase 3 HOPE-3 trial evaluating deramiocel in patients with Duchenne Muscular Dystrophy (DMD).The data demonstrated that the cell therapy sharply slowed the decline of upper-limb function compared to a placebo over the two-year evaluation period.
The functional preservation data is central to Capricor’s revised commercial pathway. The findings directly support the core efficacy metrics currently under review by the U.S. Food and Drug Administration (FDA) for the drug’s amended Biologics License Application.
Following the clinical results, B. Riley upgraded Capricor from Neutral to Buy on Wednesday morning, raising its price target on the stock from $5 to $21.
Rebounding from Regulatory Setbacks
Wednesday’s momentum marks a reversal in sentiment after Capricor shares lost a majority of their value in late July. The steep sell-off was triggered when an FDA Advisory Committee voted against recommending approval for deramiocel for its originally targeted indication of DMD-related cardiomyopathy.
Following the negative panel vote, Capricor narrowed the scope of its BLA to focus explicitly on preserving upper-limb function in DMD patients. To accommodate the review of the newly submitted 24-month HOPE-3 data and the amended clinical indication, the FDA subsequently extended the drug’s PDUFA target action date to Nov. 22.
While regulatory risks remain elevated heading into the November decision, analysts note that the late-breaking upper-limb efficacy data provides the fundamental clinical backing necessary to support the revised application.
CAPR Stock Surges Wednesday
CAPR Price Action: Capricor Therapeutics shares were up 11.79% at $9.59 at the time of publication on Wednesday, according to Benzinga Pro data.
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