Shares of Capricor Therapeutics experienced a significant 10% surge yesterday, closing at $6.79. This substantial gain was driven by a pivotal clarification from the U.S. Food and Drug Administration (FDA) concerning the regulatory pathway for its stem cell therapy, Deramiocel.
A Constructive Shift from Regulators
The recent development marks a notable turnaround for the biotechnology firm. Following a Type-A meeting with the regulatory agency, Capricor confirmed that the FDA has agreed to accept the already-completed HOPE-3 clinical study. This study will serve as the “additional study” requested in the Complete Response Letter issued back in July 2025. This agreement is a critical step, allowing the company to integrate the HOPE-3 data directly into its existing Biologics License Application (BLA), thereby facilitating a faster resumption of the review process.
Market experts immediately responded to the positive regulatory news, with several firms reaffirming their confidence in the stock on Friday:
– Maxim Group (Jason McCarthy): Buy rating
– Oppenheimer: Buy rating
– JonesTrading: Buy rating
– B. Riley Financial: Buy rating
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This broad analyst support underscores the growing conviction in Deramiocel’s approval prospects. The therapy is intended to treat Duchenne muscular dystrophy, a severe genetic disorder.
Path Forward and Key Milestones
The FDA has also indicated a degree of flexibility in its assessment of the forthcoming data. Topline results from the HOPE-3 study, which enrolled 105 participants, are anticipated around the middle of the fourth quarter of 2025. The crucial near-term catalyst will be the release of this data in the coming weeks. A successful conclusion to the regulatory process could potentially set the stage for Deramiocel’s market launch by 2027.
The cooperative stance from the FDA represents a constructive change in direction after the setback earlier this year, positioning Capricor for a potentially accelerated approval timeline.
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