SRPT Slides on Voluntary US Elevidys Shipment Pause Amid Scrutiny

Core Insights - Sarepta Therapeutics (SRPT) is experiencing a decline in share price following the announcement of a voluntary and temporary halt to all U.S. shipments of its gene therapy Elevidys, which is designed for Duchenne muscular dystrophy (DMD) [1][3] Company Developments - The pause in shipments is a proactive measure to address information requests and complete the safety labeling supplement process with the FDA, indicating the company's commitment to a science-based review [2][8] - Elevidys has been a significant revenue driver for Sarepta, contributing over half of the company's total revenues in Q1 2025, and the halt is expected to have a substantial negative impact on financial performance in the latter half of the year [3][8] - The decision to halt shipments follows the death of a patient in a clinical trial, marking the third patient death linked to Sarepta's gene therapies, which raises serious safety concerns [4][5][6] Regulatory Actions - The FDA has placed all of Sarepta's clinical studies for limb-girdle muscular dystrophy (LGMD) on hold due to the patient deaths associated with acute liver failure (ALF) [6][7] - The agency requested the voluntary stop of Elevidys shipments, which Sarepta initially resisted but ultimately complied with [7][8] Financial Restructuring - In response to the challenges, Sarepta announced a major restructuring plan that includes cutting 36% of its workforce, approximately 500 employees, to achieve annual savings of $120 million, alongside a reprioritization of its pipeline to save an additional $300 million per year [12][14] - The company is now focusing on its siRNA pipeline, which was acquired through a recent deal with Arrowhead Pharmaceuticals, targeting various conditions and expecting initial clinical data by year-end [14] Market Performance - Year-to-date, Sarepta's shares have plummeted by 89%, contrasting sharply with the industry's modest decline of 2.2% [7]