Capricor Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update Deramiocel BLA for Duchenne muscular dystrophy under U.S. FDA review with PDUFA target action date of August 22, 2026 Pivotal HOPE-3 Phase 3 trial achieved primary endpoint (PUL v2.0) and key secondary cardiac endpoint (LVEF) Late-breaking HOPE-3 data presented at MDA 2026 demonstrated additional

#CAPR Capricor Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

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Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA Capricor Therapeutics (NASDAQ: CAPR) announced the FDA has lifted its Complete Response Letter and resumed review of the Deramiocel BLA as a Class 2 resubmission, setting a PDUFA target action date of August 22, 2026. The company expects potential eligibility for a Priority Review Voucher upon approval.Deramiocel is supported by positive HOPE-3 Phase 3 results and holds multiple designations including Orphan Drug, RMAT, ATMP, and Rare Pediatric Disease.

#CAPR Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA

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JUST IN: ( NASDAQ: #CAPR ) Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data Capricor (NASDAQ: CAPR) said the FDA has requested the full HOPE-3 clinical study report (CSR) as part of its Biologics License Application (BLA) review for Deramiocel and did not ask for additional clinical studies or new patient data. The company is preparing the HOPE-3 CSR and plans to submit the requested materials in February 2026 to address the Complete Response Letter (CRL) received in July 2025, with the goal of supporting continued review and assignment of a new PDUFA target action date.HOPE-3 randomized 106 subjects across ambulatory and non-ambulatory cohorts; Deramiocel holds multiple regulatory designations including Orphan, RMAT, ATMP, and Rare Pediatric Disease.

#CAPR Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data

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NEWS: ( NASDAQ: #CAPR ) Here's Why This Biotechnology Skyrocketed by 439% in December

Just In: ( NASDAQ: #CAPR ) CAPR Price Target Alert: $54.00. Issued by Oppenheimer

Capricor Therapeutics Announces Pricing of $150 Million Public Offering of Common Stock Capricor Therapeutics (NASDAQ: CAPR) priced an underwritten public offering of 6,000,000 common shares at $25.00 per share, with gross proceeds expected to be $150 million before fees. The company granted underwriters a 30-day option to purchase up to an additional 900,000 shares at the public offering price, less underwriting discounts and commissions.The offering is expected to close on or about December 8, 2025, subject to customary closing conditions. Net proceeds are intended for continued product development, manufacturing, working capital and general corporate purposes. The securities are offered under an effective Form S-3 shelf registration declared effective September 23, 2025.

#CAPR Capricor Therapeutics Announces Pricing of $150 Million Public Offering of Common Stock

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Capricor Therapeutics Announces Proposed Public Offering of Common Stock Capricor Therapeutics (NASDAQ: CAPR) announced the commencement of a proposed underwritten public offering of its common stock on December 4, 2025. The company said it will grant underwriters a 30-day option to purchase additional shares equal to 15% of the aggregate shares sold.The offering is subject to market conditions and may not be completed as proposed. Piper Sandler and Oppenheimer are joint book-running managers. Net proceeds are intended for product development, manufacturing, working capital and general corporate purposes. Securities will be offered under an effective Form S-3 (File No. 333-290179) declared effective on September 23, 2025.

#CAPR Capricor Therapeutics Announces Proposed Public Offering of Common Stock

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Just In: ( NASDAQ: #CAPR ) CAPR Price Target Alert: $48.00. Issued by Industrial Alliance Securities

News; ( NASDAQ: #CAPR ) Capricor Therapeutics Inc. (NASDAQ: CAPR) Sees Notable Increase in Wednesday Morning Market Activity

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Just In: ( NASDAQ: #CAPR ) Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy

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Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance (p=0.03 and p=0.04, respectively) Statistical significance was achieved in all type 1 error

#CAPR Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy

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Shorters won’t take down Capricor Therapeutics, this analyst says Roth Capital Markets analyst Boobalan Pachaiyappan reiterated a “Buy” rating and $13.00 price target on CAPR

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