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Capricor Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update
-Completed Targeted Enrollment for HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy- -On Track to Report Interim Futility Analysis in
About this update from Capricor Therapeutics, Inc.
[{"type":"text","content":"-Completed Targeted Enrollment for HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy- -On Track to Report Interim Futility Analysis in Fourth Quarter of 2023; Successful Outcome Would Trigger Milestone Payment to Capricor Under Commercialization and Distribution Deal with Nippon Shinyaku- -Positive FDA Feedback on the Proposed Key Clinical and Regulatory Requirements Confirms CAP-1002’s Path Towards a Biologics License Application Submission- -Conference Call and Webcast Today at 4:30 p.m. ET- SAN DIEGO, Nov. 14, 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 third quarter ended September 30, 2023 and provided a corporate update. “During our recent meeting with the U.S. Food and Drug Administration (FDA), we aligned on key features of our Phase 3 pivotal program and are pleased to have completed the targeted enrollment in this study, which marks a major milestone on our path towards potential approval of CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD),” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “While there are limited treatment options currently available for patients with DMD, we believe the potential for slowing of disease progression, robust and consistent efficacy, together with the favorable safety/tolerability profile, positions CAP-1002 as a potential anchor therapy. Further, we will continue to discuss options for expedited approval pathways with the FDA and in parallel, are well-positioned to execute on important clinical and regulatory milestones including reporting the outcome of an interim futility analysis in the fourth quarter of 2023, followed by top-line data in late 2024.” Dr. Marbán continued, “While our major focus is on commercializing CAP-1002, we continue to progress our proprietary StealthX™ platform technology as part of our long-term strategy to leverage exosomes for therapeutic development. We continue to explore partnership opportunities and other non-dilutive sources of funding to advance this program.” Third Quarter 2023 and Recent Operational Developments CAP-1002 Duchenne Muscular Dystrophy Program Cohort A o...