Core Viewpoint - Sarepta Therapeutics has clarified that the death of an 8-year-old child is not related to its gene therapy product, Elevidys, and has reported the incident to the FDA on June 18 [1] Company Summary - Sarepta Therapeutics is actively addressing concerns regarding the safety of its gene therapy product, Elevidys, following the reported death of a child [1] - The company has taken the necessary steps to inform the FDA about the incident, indicating a commitment to regulatory compliance and transparency [1] Industry Summary - The incident highlights ongoing scrutiny and regulatory oversight in the gene therapy sector, particularly concerning the safety profiles of new treatments [1] - The response from Sarepta Therapeutics may influence investor confidence and public perception of gene therapy products in the market [1]
Sarepta Therapeutics发布澄清公告:8岁儿童的死亡与本公司基因疗法Elevidys无关。6月18日已经向美国食品药品管理局(FDA)通报了这起事故。