Sarepta Therapeutics announced a sweeping restructuring plan on July 16, 2025, eliminating approximately 36% of its workforce—around 500 employees—in a move aimed at cutting costs and stabilizing the company after recent clinical and financial turmoil (Bloomberg).
The biotech firm, Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, plans to save $400 million annually starting in 2026. In addition to job cuts, Sarepta is halting multiple development programs, including several gene therapies for limb-girdle muscular dystrophy (LGMD), and shifting focus to its promising siRNA platform. These changes also help the company maintain access to a $600 million revolving credit facility, as reported by BioPharma Dive.
Sarepta’s market value had plummeted over 85% in early 2025 following clinical setbacks and regulatory scrutiny, prompting the urgent need to reduce expenses and recalibrate its research priorities.
Elevidys Deaths Prompt FDA Action and Black‑Box Warning
The restructuring by Sarepta Therapeutics comes in the wake of two tragic patient deaths tied to Sarepta’s Duchenne muscular dystrophy gene therapy, Elevidys. Both patients reportedly died from acute liver failure—one in March and another in June. Following these incidents, Sarepta paused shipments of the therapy to non‑ambulatory patients and began reexamining its safety protocols.
In coordination with the FDA, Sarepta has now agreed to apply a black‑box warning—the most severe safety label—highlighting risks of acute liver injury and liver failure in ambulatory Duchenne patients. This move preserves Elevidys’ availability for certain patients while acknowledging the serious safety concerns raised by regulators.
To address risks for non‑ambulatory patients, the company is pursuing additional safety measures, including a revised immunosuppressive regimen using sirolimus. It plans to present new data to the FDA through an expanded cohort in its ongoing ENDEAVOR Phase I trial.
Analysts believe that introducing the black‑box warning may reduce the risk of a full market withdrawal while signaling a more cautious, regulator-aligned approach by Sarepta Therapeutics.
Leadership Shifts, Revenue Outlook, and Market Response
Amid the restructuring, Sarepta Therapeutics also announced key leadership changes. Ian Estepan was promoted to President and COO, while Ryan Wong was appointed CFO, reinforcing stability during a turbulent period.
Despite the recent setbacks, Sarepta reported preliminary Q2 revenue of $513 million, with $282 million coming from Elevidys sales. While full-year guidance remains withdrawn, the company estimates ambulatory Elevidys sales could exceed $500 million annually through 2027.
Investors reacted positively to the restructuring announcement. Shares of Sarepta soared 33%–40% in after-hours trading as the company demonstrated clear steps to control costs, refocus priorities, and preserve its lead asset. Analysts from Evercore and Jefferies noted that the restructuring signals a more aggressive and focused strategy to overcome regulatory, clinical, and commercial challenges.
Sarepta Therapeutics sweeping changes mark a pivotal moment for the biotech company. By cutting 500 jobs, introducing a black‑box warning for its gene therapy, and reprioritizing its development pipeline, Sarepta aims to rebuild investor trust and ensure the future of Elevidys while safeguarding patient outcomes. The months ahead will be crucial as the company works closely with the FDA and readjusts its strategic trajectory.
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