Capricor Therapeutics, Inc. (CAPR) Q1 2026 Earnings Call Transcript
Capricor Therapeutics, Inc. (CAPR) Q1 2026 Earnings Call Transcript
CAPR - Capricor Therapeutics, Inc.
Capricor Therapeutics, Inc. (CAPR) Q1 2026 Earnings Call Transcript
Capricor Therapeutics NASDAQ: CAPR said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku.
Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected to commence soon HOPE-3 Phase 3 trial met its primary endpoint (PUL v2.0; upper limb function) and all Type I error-controlled secondary endpoints GMP manufacturing facility fully operational; second-floor expansion well underway Chief Commercial Officer with direct DMD commercial experience expected to join the Company in the coming weeks Filed suit against Nippon Shinyaku Co., Ltd. and NS Pharma, Inc. seeking rescission of U.S. distribution agreement and preliminary injunction; FDA review and PDUFA date unaffected Cash balance of approximately $279 million expected to support operations into Q4 2027 Eligible for a Priority Review Voucher upon approval; PRV is transferable and monetizable, offering potential non-dilutive capital Conference call and webcast today at 4:30 p.m.
Focused on advanced cell therapies for rare diseases, this biotech firm reported a notable insider sale in its latest SEC filing.
Capricor Therapeutics Inc. (NASDAQ:CAPR) on Thursday filed a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary NS Pharma, Inc., alleging that flaws in the companies' U.S. distribution agreement for experimental Duchenne muscular dystrophy treatment Deramiocel could limit patient access to the therapy.
– Company to Host Conference Call on May 12, 2026, at 4:30 p.m. ET – SAN DIEGO, May 04, 2026 (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 it will release its financial results for the first quarter ended March 31, 2026, after the market close on Tuesday, May 12, 2026.
Capricor Therapeutics, Inc. (NASDAQ: CAPR - Get Free Report) CFO Anthony Bergmann sold 25,000 shares of the firm's stock in a transaction dated Tuesday, March 31st. The stock was sold at an average price of $30.13, for a total transaction of $753,250.00. Following the completion of the transaction, the chief financial officer directly owned 8,223 shares
Capricor Therapeutics, Inc. (NASDAQ: CAPR - Get Free Report) Director Karimah Es Sabar sold 61,265 shares of Capricor Therapeutics stock in a transaction that occurred on Tuesday, March 31st. The stock was sold at an average price of $30.17, for a total transaction of $1,848,365.05. The transaction was disclosed in a filing with the Securities and
Capricor Therapeutics, Inc. (NASDAQ: CAPR - Get Free Report) Director Karimah Es Sabar sold 53,735 shares of the company's stock in a transaction dated Wednesday, April 1st. The stock was sold at an average price of $31.03, for a total value of $1,667,397.05. The transaction was disclosed in a document filed with the Securities and Exchange
Capricor Therapeutics, Inc. (NASDAQ: CAPR - Get Free Report)'s stock price crossed above its 50 day moving average during trading on Monday. The stock has a 50 day moving average of $26.80 and traded as high as $29.27. Capricor Therapeutics shares last traded at $27.77, with a volume of 745,376 shares traded. Wall Street Analyst
Capricor Therapeutics (NASDAQ: CAPR - Get Free Report) and Zimmer Biomet (NYSE: ZBH - Get Free Report) are both medical companies, but which is the superior business? We will contrast the two businesses based on the strength of their risk, earnings, analyst recommendations, valuation, profitability, dividends and institutional ownership. Profitability This table compares Capricor Therapeutics and Zimmer
Capricor Therapeutics is upgraded from 'Hold' to 'Buy' following FDA acceptance of the HOPE-3 clinical study report for Deramiocel in DMD cardiomyopathy. The FDA lifted the Complete Response Letter and set a PDUFA date of August 22, 2026, without requiring new studies, increasing regulatory clarity. Phase 3 HOPE-3 data showed Deramiocel slowed disease progression by 54% [PUL] and 91% [LVEF], with additional functional and fibrosis benefits.
Capricor posted a quarterly loss of 62 cents per share, missing the consensus estimate of a 54-cent loss and worsening from a 16-cent loss in the prior-year period.
Capricor Therapeutics, Inc. (CAPR) Q4 2025 Earnings Call Transcript
SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.
SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced additional analyses and new functional outcomes data from the Phase 3 HOPE-3 clinical trial of Deramiocel in Duchenne muscular dystrophy (DMD), which were presented yesterday at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.
Here's what investors need to know.
SAN DIEGO, March 10, 2026 (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 U.S. Food and Drug Administration (“FDA”) has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application (“BLA”) seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy (“DMD”) cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 22, 2026.
SAN DIEGO, March 10, 2026 (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 U.S. Food and Drug Administration (“FDA”) has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application (“BLA”) seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy (“DMD”) cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 22, 2026.
The U.S. Food and Drug Administration Commissioner Marty Makary confirmed on Friday that Dr. Vinay Prasad, head of its Center for Biologics Evaluation and Research (CBER), is set to leave his position in April.