Capricor Therapeutics announces manufacturing scale-up of CAP-1002 production

Capricor Therapeutics announced the scale-up to expand manufacturing capacity of CAP-1002 to its new state-of-the-art manufacturing facility, intended for commercial use, subject to regulatory approval, located in San Diego. Furthermore, the Company announced that Cohort B of its HOPE-3, Phase 3 clinical study is enrolling rapidly and is expected to complete full enrollment in the second quarter of 2024. “We are extremely pleased with the progress of our manufacturing scale-up efforts in connection with our new San Diego facility which brings us one step closer towards a successful launch of CAP-1002, should we obtain approval, to meet the significant unmet need in this broad and underserved patient population. This facility was designed to be a versatile and cost-effective way to bring CAP-1002 to market efficiently and it is expected that our enhanced manufacturing capacity to increase our supply capabilities and improve our margins,” said Linda Marban, Ph.D., Capricor’s chief executive officer. “Furthermore, with Cohort A of the HOPE-3 trial being fully enrolled and topline data readout expected in the fourth quarter of 2024, we plan to meet with the U.S. Food & Drug Administration (FDA) with the aim to discuss possible expedited pathways to approval.”