Capricor Therapeutics Inc (NASDAQ:CAPR) stock is trading higher on Monday as investors react to the FDA’s continued review of deramiocel update.
The U.S Food and Drug Administration (FDA) extended the PDUFA target action date for deramiocel, setting a new target of November 22.
Investors are probably reacting because the FDA did not issue a Complete Response Letter requesting additional data or studies to approve the drug.
The extended timeline still keeps hopes for the Duchenne muscular dystrophy cell therapy.
CAPR Jumps On FDA PDUFA Extension For Deramiocel
As part of its ongoing discussions with the FDA following the July 2026 Advisory Committee meeting, Capricor submitted an amendment to the marketing application.
It included 24-month open-label extension data from its pivotal Phase 3 HOPE-3 study and additional robustness analyses, with a request that the FDA review the existing and new data in support of a refined proposed indication focused on upper limb function, the primary endpoint of HOPE-3.
The FDA’s Center for Biologics Evaluation and Research (CBER) accepted the amendment for review.
The FDA has classified the submission as a major amendment and extended the PDUFA target action date by three months to allow additional time to review the information.
“With an additional year of follow-up from HOPE-3, we now have one of the most extensive clinical datasets evaluating upper limb function in Duchenne,” said Linda Marbán, CEO of Capricor.
FDA Advisory Panel Questions Deramiocel Effectiveness
In July, the FDA Advisory Committee voted against Deramiocel.
The FDA advisory panel voted 9-3 that the company failed to provide sufficient evidence supporting Deramiocel’s effectiveness, echoing FDA staff concerns over post hoc changes to key analyses after the late-stage trial concluded.
Analyst Consensus & Recent Actions: The stock carries a Buy rating with an average price forecast of $38.25 (high: $63.00, low: $2.00) across 10 analysts. Recent analyst moves include:
- Cantor Fitzgerald: Upgraded to Overweight (Raises Forecast to $28.00) (August 14)
- Jones Trading: Downgraded to Hold (July 31)
- Piper Sandler: Downgraded to Neutral (Lowers Forecast to $2.00) (July 30)
How CAPR Ranks On Momentum Versus The Market
Below is the Benzinga Edge scorecard for Capricor Therapeutics, highlighting its strengths and weaknesses compared to the broader market:
- Momentum: Bearish (Score: 1.17) — Despite today’s spike, the broader momentum signal remains very weak versus the market.
The Verdict: Capricor Therapeutics’s Benzinga Edge signal reveals a momentum-challenged setup, with the scorecard currently dominated by a very weak Momentum reading.
For traders, that often means the stock may be more headline-driven than trend-driven until sustained follow-through improves the momentum profile.
CAPR Stock Price Activity: Capricor Therapeutics shares were up 14.07% to $7.17 at the time of publication on Monday, according to Benzinga Pro data.
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