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CAPRICOR THERAPEUTICS, INC.
Millennium Management LLC and Israel A. Englander have entered into a joint filing agreement regarding the Schedule 13G disclosure for their beneficial ownership of Capricor Therapeutics, Inc. common stock. The agreement, dated October 13, 2026, confirms that the filing will be submitted on behalf of all named parties in accordance with Rule 13d-1(k).…more
CAPRICOR THERAPEUTICS, INC.
Millennium Management LLC, Millennium Group Management LLC, and Israel A. Englander have filed a Schedule 13G regarding their beneficial ownership of Capricor Therapeutics, Inc. common stock. This filing confirms the joint reporting agreement dated September 11, 2026, for the entities to report their holdings collectively.…more
CAPRICOR THERAPEUTICS, INC.
The U.S. FDA has extended the PDUFA target action date for the Biologics License Application (BLA) of Deramiocel, a treatment for Duchenne muscular dystrophy, from August 22, 2026, to November 22, 2026. This three-month extension follows the company's submission of a major amendment including 24-month open-label extension data from the Phase 3 HOPE-3 study and a refined indication focused on upper limb function.…more
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Capricor Therapeutics Shares Slide Amid FDA Concerns Over DMD Drug
Capricor Therapeutics shares fell after the FDA indicated that the company's submitted data for its DMD drug, Deramiocel, lacks substantial evidence of effectiveness. The company faces a final FDA decision on November 22, with regulatory skepticism weighing heavily on the stock.…more
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Capricor announced that its DMD treatment, Deramiocel, slowed upper limb function decline by 76% in the Phase 3 open-label extension study. The data has been submitted to the FDA, with a PDUFA target action date set for November 22, 2026.…more
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Capricor Therapeutics will present 24-month clinical data for its DMD treatment, Deramiocel, at the upcoming World Muscle Society Congress. These findings were included in the company's recent BLA amendment currently under FDA review.…more
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