Business
Capricor Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update
-Presented Statistically Significant 24-Month HOPE-2 Open Label Extension Data at the PPMD Annual Conference- -Enrollment Continues to Progress in HOPE-3, the
About this update from Capricor Therapeutics, Inc.
[{"type":"text","content":"-Presented Statistically Significant 24-Month HOPE-2 Open Label Extension Data at the PPMD Annual Conference- -Enrollment Continues to Progress in HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy; On Track to Complete Enrollment and Report Interim Analysis in Fourth Quarter of 2023- -Held Type-B Clinical Meeting with the FDA to Discuss CAP-1002’s Pathway Towards Potential Biologics License Application Submission- -Conference Call and Webcast Today at 4:30 p.m. ET- SAN DIEGO, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today its financial results for the second quarter ended June 30, 2023 and provided a corporate update. “In the second quarter of 2023 we presented positive two-year data from our ongoing HOPE-2 open label extension (OLE) study, which we believe further supports our rapidly advancing late-stage clinical development program for CAP-1002 in patients with Duchenne Muscular Dystrophy (DMD),” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “The robust and consistent results seen after two years of treatment with CAP-1002 are tremendously impactful for DMD patients, showing evidence of skeletal and cardiac functional improvements, which underscores the potential long-term benefit of CAP-1002 treatment. We recently held a clinical meeting with the U.S. Food and Drug Administration (FDA) to discuss these results, together with key features of our ongoing Phase 3 HOPE-3 trial. The objective was to outline the proposed path towards submission of a potential Biologics License Application (BLA) in the most expeditious way possible, and we look forward to sharing the outcome of this meeting once we receive final meeting minutes from the FDA. Additionally, with progress of HOPE-3 accelerating, we expect to complete enrollment and report the outcome from the interim analysis in the fourth quarter of 2023.” Dr. Marbán continued, “Further, as we remain committed to driving shareholder value as well as maximizing the value of CAP-1002, we continue to explore opportunities for additional partnerships for DMD as well as new potential indications for which CAP-1002 can provide benefi...