CAPR Stock Draws Investor Attention After AAN Presentation For DMD Therapy

• The company’s management highlighted that video-based assessments of everyday tasks showed that Deramiocel helped slow disease progression.
• The U.S. FDA is expected to announce its decision on Deramiocel on August 22.
• According to a Bloomberg report, a former Capricor executive is being considered for a key leadership role at the FDA’s Center for Biologics Evaluation and Research.

Capricor Therapeutics (CAPR) drew investor attention on Wednesday, after the biotech firm presented data from its Phase 3 HOPE-3 trial of Deramiocel for Duchenne Muscular Dystrophy (DMD) at the American Academy of Neurology 2026 Annual Meeting in Chicago.

CAPR shares gave up early gains, trading 1% lower.

FDA Decision Expected In August

Capricor’s Biologics License Application (BLA) for the treatment is currently under review by the U.S. Food and Drug Administration (FDA), with a decision expected by Aug. 22, 2026.

The U.S. Food and Drug Administration resumed its review of Deramiocel in March after previously issuing a Complete Response Letter in July 2025, indicating the therapy needed additional data for approval. Capricor resubmitted its application with updated Phase 3 HOPE-3 results, which showed a 54% slower decline in upper-limb function and a 91% reduction in cardiac disease progression compared to placebo.

Further supporting the findings, cardiac MRI data showed a significant reduction in heart scarring in patients treated with Deramiocel after 12 months. The therapy is designed to reduce inflammation linked to muscle damage in DMD.

Treatment Highlights Patients’ Ability To Feed Themselves

The firm’s management highlighted that video-based assessments of everyday tasks also showed that Deramiocel helped slow disease progression, especially in patients’ ability to feed themselves.

“No therapeutic has ever delivered a statistically and clinically meaningful difference in the upper limb functional primary endpoint of Performance of the Upper Limb (PUL v2.0),” said Aravindhan Veerapandiyan, Associate Professor and Director of the Comprehensive Neuromuscular Program at Arkansas Children's Hospital.

“These findings were further supported by an alternative measure of upper limb function, specifically video recordings of tasks performed at home, which showed meaningful slowing of disease progression in the ability to self-feed, a function central to patient independence.”

Meanwhile, retail sentiment on Stocktwits remained ‘bullish’ over the past 24 hours, amid ‘high’ message volumes.

Hemmati’s Potential FDA Appointment Sparks Retail Buzz

A former Capricor executive is being considered for a key leadership role at the U.S. Food and Drug Administration, according to a Bloomberg report last week.

Houman Hemmati is among the candidates being interviewed by FDA Commissioner Marty Makary to lead the Center for Biologics Evaluation and Research (CBER), the division responsible for reviewing vaccines and advanced gene and cell therapies, including treatments for rare diseases like Duchenne muscular dystrophy.

However, no final decision has been made yet, and the agency is still reviewing potential candidates.

One user expects the stock to pop on the confirmation of the news.

The leadership vacancy at the CBER follows the departure of Vinay Prasad, whose tenure drew criticism from parts of the biotech industry over regulatory decisions on rare-disease treatments.

The stock has gained more than 17% so far this year.

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