Capricor Therapeutics announces continuation of Phase 3 HOPE-3 trial

Capricor Therapeutics announced the outcome of the interim futility analysis for HOPE-3, the pivotal Phase 3 trial evaluating CAP-1002 in patients with Duchenne muscular dystrophy. The results of the interim futility analysis, reviewed by the Data Safety Monitoring Board, resulted in a favorable recommendation to continue the HOPE-3 trial as planned. This interim futility analysis triggers the first milestone payment under the Company’s U.S. Commercialization and Distribution Agreement with Nippon Shinyaku Co., Ltd. “We are pleased with the positive outcome of the DSMB review which supports the continued advancement of our HOPE-3 trial towards potential approval of CAP-1002 for the treatment of DMD,” said Linda Marban, Ph.D., Capricor’s chief executive officer. “We believe CAP-1002 may address the high unmet medical need for these patients and we remain committed to its expeditious advancement towards approval. Based on this important milestone, we will be requesting a meeting with the U.S. Food and Drug Administration to further discuss options for expedited review and approval. In addition, we believe we are well positioned to execute on additional value-driving clinical and regulatory milestones, including reporting topline data from HOPE-3 in the fourth quarter of 2024.”