Capricor Therapeutics (CAPR) Company Overview

Capricor stock gains 8% upon completing the rolling submission of the BLA for its lead asset, deramiocel, to treat DMD cardiomyopathy in the United States.

-If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy- -BLA submission triggers $10 million milestone payment to Capricor from Nippon Shinyaku- SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking full approval for deramiocel, an investigational cell therapy, to treat patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. “The submission of the BLA marks a pivotal step for Capricor and those impacted by DMD.

Capricor Therapeutics is advancing deramiocel, an allogeneic cell therapy for DMD-related cardiomyopathy, with a rolling BLA submission and potential FDA approval by 2025. Deramiocel showed significant improvements in upper limb function and LVEF in Phase 2 trials, with ongoing open-label extension trials supporting long-term efficacy and safety. Despite promising prospects, Capricor's upside is limited due to prior commercialization deals, but the stock remains attractively valued with potential milestone payments and royalties.

Capricor Therapeutics initiated its rolling BLA submission for Deramiocel to treat Duchenne Muscular Dystrophy Cardiomyopathy, with completion expected before the end of 2024. The company presented promising 3-year data from the HOPE-2 OLE study, showing significant improvements in cardiac and skeletal muscle functions. Capricor raised $86.3 million in a public offering, ensuring sufficient cash runway to fund operations into 2027, excluding potential milestone payments from Nippon Shinyaku.

SAN DIEGO, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the Company is scheduled to present at the following upcoming investor conferences.

Capricor Therapeutics (CAPR) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.25 per share a year ago.

Capricor (CAPR) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

SAN DIEGO, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today the closing of its previously announced underwritten public offering of 5,073,800 shares of its common stock, including the exercise in full of the underwriters' option to purchase additional shares to cover over allotments, bringing the total gross proceeds to Capricor from the offering to approximately $86.3 million, before deducting underwriting commissions and other offering expenses payable by Capricor. All of the shares of common stock sold in the offering, including the over-allotment, were offered by Capricor. The closing of the offering occurred on October 18, 2024.

SAN DIEGO, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the pricing of its underwritten offering of 4,412,000 shares of common stock at a public offering price of $17.00 per share. Capricor also granted the underwriters a 30-day option to purchase up to an additional 661,800 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on October 18, 2024, subject to the satisfaction of customary closing conditions.