Sarepta Therapeutics Stock Skyrockets After FDA U-Turn – Gene Therapy Drama Explained
The FDA on July 28, 2025, cleared Elevidys gene therapy shipments for ambulatory patients after finding no link to a child’s death, while Sarepta added black-box liver warnings. Sarepta’s Q2 revenue jumped 68% to $611.1 million, but shares plunged 85% YTD before rebounding to $22.35 after the FDA decision. The EU’s CHMP issued a negative opinion on Elevidys, delaying European approval. Sarepta cut 36% of its workforce in July.