3期成功回应CRL，股价暴涨371%

Core Viewpoint - Capricor's Deramiocel shows positive results in the pivotal Phase 3 HOPE-3 study, supporting its potential as a preferred treatment for Duchenne muscular dystrophy (DMD) [1][8] Group 1: Study Results - The HOPE-3 trial demonstrated a 54% slowing of disease progression in upper limb function (PUL v2.0) compared to placebo (p=0.029) and a 91% slowing in left ventricular ejection fraction (LVEF) (p=0.041) [5][13] - The study involved 106 participants, with an average age of 15, receiving either Deramiocel or placebo over 12 months [4][12] - Results indicate significant clinical benefits in both skeletal and cardiac aspects, reinforcing Deramiocel's potential as a leading therapy for DMD [6][14] Group 2: Regulatory and Market Implications - Following the positive HOPE-3 results, Capricor plans to discuss the findings with the FDA as part of their response to a complete response letter (CRL) [1][8] - If approved, Deramiocel would be the first drug for treating DMD, with analysts predicting a favorable market outlook and interest from physicians [7][15] - The safety and tolerability of Deramiocel align with previous clinical experiences, enhancing its chances for regulatory approval [6][14]