All Eyes On Capricor Therapeutics Ahead Of Crucial Hearing On DMD Therapy Agreement – CAPR Stock Jumps 6%

• In May, Capricor filed a lawsuit against Nippon Shinyaku and NS Pharma over their U.S. distribution agreement for the DMD therapy Deramiocel.
• Capricor said a pricing issue could limit patient access to the therapy through Medicare, Medicaid, and private insurance plans.
• The PDUFA date for Deramiocel is set for Aug. 22, 2026

Capricor Therapeutics (CAPR) was in the limelight on Wednesday with investors keeping an eye on developments in the company’s legal dispute with Nippon Shinyaku and its U.S. subsidiary, NS Pharma, over the distribution agreement for its Duchenne Muscular Dystrophy (DMD) therapy.

CAPR shares were trading around 6% higher at the time of writing.

What’s The Legal Dispute About?

Last month, Capricor filed a lawsuit against Nippon Shinyaku and NS Pharma over a dispute involving the commercialization of Deramiocel, the company's experimental treatment for DMD.

According to the complaint, Capricor believes the current distribution agreement includes a pricing structure that could make the therapy difficult for patients covered by Medicare, Medicaid, and private insurance plans to access.

The company argued that hospitals, treatment centers, and distributors could face financial losses when administering the treatment under the existing arrangement. Capricor said it attempted to resolve the issue with NS Pharma but was unable to reach an agreement.

An oral argument on the matter is scheduled for later on Wednesday.

FDA Decision On CAPR’s Therapy Is Scheduled For August

Deramiocel is being developed to treat both the muscle and heart complications associated with DMD, a rare and fatal genetic disorder that affects roughly 15,000 people in the United States.

In March, the FDA lifted a previously issued Complete Response Letter and resumed review of its Biologics License Application (BLA) seeking full approval of Deramiocel, with the Prescription Drug User Fee Act (PDUFA) date set for Aug. 22, 2026.

A PDUFA date is the FDA’s target date for making a decision on a drug application, which allows the drug to be marketed in the U.S.

What Is Retail’s Take On CAPR?

Retail sentiment surrounding CAPR on Stocktwits trended in the ‘bullish’ zone over the past 24 hours, accompanied by ‘high’ message volumes.

One user highlighted the potential impact on CAPR for launching the drug independently.

Another user said the stock’s movement could be attributed to the “tailwinds” from uniQure’s BLA resubmission update earlier in the day.

The stock has shed more than 7% of its value so far this year.

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