Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Company Performance & Regulatory Actions - Shares of Sarepta Therapeutics experienced a pre-market increase of approximately 36% [1] - Sarepta Therapeutics will resume shipping Alvdus, a gene therapy for muscular disorders, to ambulatory patients [1] - The FDA had previously recommended a pause in shipments due to safety concerns following three patient deaths [1] - Sarepta's stock is still down by about 84% this year [1] Safety Concerns & FDA Response - Initial concerns arose regarding deaths in non-ambulatory patients [2] - The FDA's Center for Biologics Evaluation and Research initially advocated for a complete halt to shipments [2] - The FDA later allowed shipments to continue for ambulatory patients due to pushback from patient families [3][4] - A recent patient death was deemed unrelated to the gene therapy by the FDA [1] Industry & Political Context - The Wall Street Journal published an op-ed criticizing the FDA's approach to drug innovation, referring to it as a "surrepta mugging" [5] - Criticism of the FDA's actions extended across the political spectrum [5][6]