Capricor Therapeutics reports Q3 EPS (25c), consensus (29c)

Reports Q3 revenue $6.18M, consensus $2.11M ..”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 Marban, 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. Marban 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.”