-FDA Feedback on the Proposed Key Clinical and Regulatory Requirements Confirms CAP-1002’s Path Towards a Biologics License Application (BLA)- -Company On Track to Complete HOPE-3 Enrollment and Report Outcome from Interim Analysis in Q4 2023- -Conference Call and Webcast Today at 8:30 a.m. ET- SAN DIEGO, Sept.

-FDA对拟议的关键临床和监管要求的反馈证实了CAP-1002走向生物制剂许可证申请（BLA）的道路-公司正在完成HOPE-3注册并报告2023年第四季度中期分析的结果-今天电话会议和网络广播上午8:30 ET-圣地亚哥，9月。

29, 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, today announced an update on the Company’s positive Type-B clinical meeting with the U.S.

292023（GLOBE NEWSWIRE）-Capricor Therapeutics（纳斯达克股票代码：CAPR）是一家专注于开发用于治疗和预防肌肉和其他特定疾病的转化细胞和基于外泌体的疗法的生物技术公司，今天宣布了该公司与美国的积极B型临床会议。

Food and Drug Administration (“FDA”) on the design and execution of HOPE-3, Capricor’s pivotal Phase 3 trial with lead asset CAP-1002 in treating Duchenne muscular dystrophy (“DMD”). Feedback from the FDA on trial design and timeline confirms CAP-1002’s path towards a future Biologics License Application (“BLA”) submission.   'We are pleased to have reached an important regulatory milestone that further defines the path towards registration of CAP-1002 for DMD and brings us potentially one step closer to addressing the great unmet medical need for these patients,” said Linda Marbán, Ph.D., Capricor’s chief executive officer.

美国食品药品监督管理局（“FDA”）关于HOPE-3的设计和执行，Capricor的关键性3期临床试验采用领先的资产CAP-1002治疗杜氏肌营养不良症（“DMD”）。FDA对试验设计和时间表的反馈证实了CAP-1002未来提交生物制剂许可证申请（“BLA”）的途径。“我们很高兴已经达到一个重要的监管里程碑，进一步确定了CAP-1002注册DMD的途径，并使我们有可能更接近解决这些患者的巨大未满足的医疗需求，”Capricor首席执行官LindaMarbán博士说。

“During recent meetings with the FDA, we aligned on key features of HOPE-3, which as currently designed, and if successful, is expected to provide sufficient evidence of effectiveness to support our BLA submission and significantly expedites our path towards potential approval of CAP-1002. In addition, although product from our San Diego site would not be required to support registration of CAP-1002, we do plan to enroll a separate cohort with product manufactured from our San Diego site, with a view toward meeti.

“在最近与FDA召开的会议中，我们就目前设计的HOPE-3的主要特点保持一致，如果成功的话，预计将提供足够的有效证据来支持我们提交的BLA，并显着加快我们获得潜在批准的道路CAP-1002。此外，尽管我们圣地亚哥站点的产品不需要支持CAP-1002的注册，但我们确实计划与我们圣地亚哥站点制造的产品一起注册一个单独的队列，以期实现meeti。