Capricor reported positive topline results from its pivotal Phase III HOPE-3 trial showing deramiocel met both its primary functional endpoint and a key cardiac secondary endpoint. The company said the data confirm earlier signals of skeletal and cardiac benefit and support regulatory resubmission efforts after a prior FDA rejection. Capricor plans to pursue the pathway agreed with regulators following a Type A meeting. Investors reacted swiftly to the readout, pushing the company’s valuation higher and renewing attention on exosome- and cell-based approaches in rare neuromuscular disease. Clinical details were disclosed in company statements and a BioCentury summary of the trial.
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