Capricor Therapeutics, INC 8-K filings

Capricor Therapeutics announced that an FDA Advisory Committee voted against the effectiveness of Deramiocel for Duchenne muscular dystrophy cardiomyopathy, though the final decision rests with the FDA.

Capricor Therapeutics announced the publication of final one-year results from its HOPE-3 Phase 3 trial for Deramiocel in Duchenne muscular dystrophy in The Lancet, with an update to the statistical model for LVEF.

Capricor Therapeutics has entered into a lease agreement for a new 171,000 sq ft headquarters and manufacturing facility in San Diego, contingent on FDA approval.

Capricor Therapeutics announced that the FDA will hold an advisory committee meeting on July 29, 2026, to review the BLA for its DMD therapy, Deramiocel.

Capricor Therapeutics, Inc. held its Annual Meeting on June 4, 2026, where stockholders voted on director elections, auditor ratification, executive compensation, and amendments to the Certificate of Incorporation.

Capricor Therapeutics announced Q1 2026 financial results, highlighting the ongoing FDA review of its Deramiocel BLA for Duchenne muscular dystrophy with a PDUFA date of August 22, 2026, and positive HOPE-3 trial results.

Capricor Therapeutics has filed a lawsuit against its distribution partner, Nippon Shinyaku and NS Pharma, alleging a fundamental pricing flaw and failure to prepare for the commercial launch of its Duchenne muscular dystrophy therapy, Deramiocel.

Capricor Therapeutics announced its Q4 and full-year 2025 financial results, highlighting the ongoing FDA review of its Deramiocel BLA for Duchenne muscular dystrophy with an August 22, 2026 PDUFA date.

Capricor Therapeutics announced the pricing of a public offering of 6 million common stock shares at $25.00 each, aiming to raise $150 million for product development and general corporate purposes.

Capricor Therapeutics announced positive top-line results from its pivotal Phase 3 HOPE-3 trial for Deramiocel in Duchenne muscular dystrophy, meeting primary and key secondary endpoints.

Capricor Therapeutics announced positive topline results from its pivotal Phase 3 HOPE-3 clinical trial for Deramiocel in Duchenne muscular dystrophy, meeting both primary and key secondary endpoints.

Capricor Therapeutics announced its third quarter 2025 financial results and provided a corporate update, with pivotal HOPE-3 Phase 3 study results for Deramiocel expected in the coming weeks.

Capricor Therapeutics announced its second quarter 2025 financial results, reporting increased losses and zero revenue, while actively pursuing resubmission of its Deramiocel BLA following a Complete Response Letter and advancing its exosome platform.

Capricor Therapeutics announced it received a Complete Response Letter from the FDA for its Biologics License Application for Deramiocel, citing insufficient evidence of effectiveness and the need for additional clinical data, but plans to resubmit with Phase 3 HOPE-3 trial data.

Capricor Therapeutics, Inc. announced the successful approval of its 2025 Equity Incentive Plan and the election of all eight director nominees at its Annual Meeting of Stockholders held on May 22, 2025.

Capricor Therapeutics announces progress on its Duchenne muscular dystrophy (DMD) treatment, deramiocel, and reports its first quarter 2025 financial results, highlighting a strong cash position.

Earl Collier, a member of Capricor Therapeutics' Board of Directors, will not seek re-election at the upcoming Annual Meeting of Shareholders.

Capricor Therapeutics reports FDA acceptance of its BLA for deramiocel with priority review, positive clinical data, and a strong cash position to support operations into 2027.

The FDA has accepted Capricor Therapeutics' Biologics License Application (BLA) for deramiocel, granting it Priority Review with a target action date of August 31, 2025, potentially marking the first approved therapy for Duchenne muscular dystrophy cardiomyopathy.

Capricor Therapeutics has finalized its Biologics License Application submission to the FDA for deramiocel, a cell therapy for Duchenne muscular dystrophy cardiomyopathy, triggering a $10 million milestone payment.

Capricor Therapeutics reported its third quarter 2024 financial results, initiated a rolling BLA submission for deramiocel, and announced a European expansion agreement with Nippon Shinyaku.

Capricor Therapeutics has priced a public offering of 4,412,000 shares of common stock at $17.00 per share, expecting to raise approximately $75 million.

Capricor Therapeutics plans to file a Biologics License Application (BLA) for deramiocel to treat Duchenne muscular dystrophy cardiomyopathy and is progressing its StealthX vaccine program.

Capricor Therapeutics has begun the rolling submission process with the FDA for its Biologics License Application (BLA) for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy.

Capricor Therapeutics plans to submit a Biologics License Application (BLA) for deramiocel to treat all patients with Duchenne muscular dystrophy (DMD) cardiomyopathy, supported by existing cardiac and natural history data.

Capricor Therapeutics has entered a binding term sheet with Nippon Shinyaku for the European commercialization of deramiocel, its lead product candidate for Duchenne muscular dystrophy, including a $15 million equity investment and a $20 million upfront payment.

Capricor Therapeutics reported positive clinical trial updates for its lead drug candidate, deramiocel, and announced its second quarter 2024 financial results, including a net loss of $11.0 million.

Capricor Therapeutics has increased its authorized common stock shares from 50 million to 100 million after receiving stockholder approval at its annual meeting.

Capricor Therapeutics held its 2024 Annual Meeting where stockholders voted on key proposals including the election of directors, ratification of auditors, executive compensation, and an increase in authorized shares.

Capricor Therapeutics announced the completion of enrollment for the Phase 3 HOPE-3 trial (Cohort A) for their Duchenne muscular dystrophy treatment, CAP-1002, and provided updates on their exosome platform.