Core Insights - Sarepta Therapeutics reported a patient death due to acute liver failure following treatment with Elevidys, the only approved gene therapy for Duchenne muscular dystrophy [1] - The European Medicines Agency (EMA) requested a temporary halt of several clinical studies involving Elevidys, including Study 104, Study 302, and Study 303, until the cause of death is analyzed [3] - Analysts express concerns about Elevidys' revenue potential, with expectations of declining sales due to safety concerns and limited effectiveness [5] Company Updates - Sarepta Therapeutics has temporarily halted clinical studies in collaboration with Roche Holdings AG following a patient death [2][3] - Patient safety monitoring for enrolled participants will continue, and data collection is ongoing [3][4] - HC Wainwright upgraded Sarepta from Sell to Neutral, indicating the stock is trading within a fair range [4] Financial Outlook - Analyst Mitchell S. Kapoor predicts Elevidys revenue will fall short in the second half of 2025, with potential sales decline as early as Q2 2025 due to safety hesitations [5] - Needham maintained a Buy rating on Sarepta but lowered the price forecast from 183 [6] - As of the last check, Sarepta's stock is down 6.68% at $58.30 [6]
Sarepta/Roche Suspend Elevidys Gene Therapy Trials In Europe After Patient Death