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Sarepta sells international rights to Duchenne gene therapy SRP-9001 to Roche for $1.15B upfront.
Roche paused Elevidys shipments July 23, 2025 in ex-US countries that reference FDA approval (Brazil, Israel, Japan, Bahrain, UAE among ~8), after two teen…
EMA issued a negative opinion on Elevidys in 2025; Roche announced April 16, 2026 a new global Phase 3 (~100 early-ambulatory DMD patients, Elevidys vs…
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In December 2019, Roche licensed ex-US rights to Sarepta's microdystrophin gene therapy program for Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies, led by SRP-9001 (delandistrogene moxeparvovec). Roche paid ~$1.15B upfront (comprising $750M cash plus a $400M equity investment) plus an $85M near-term milestone, with up to $500M in additional milestones and significant ex-US royalties (~$1.735B total disclosed); Sarepta retained US rights and manufacturing while Roche took regulatory approval and commercialization outside the US. Post-close, SRP-9001 was approved by the FDA as ELEVIDYS on June 22, 2023 - the first gene therapy for DMD (accelerated approval, later expanded) - and Roche launched it across ex-US markets including Japan (first commercial sale and a $40M milestone to Sarepta in Q1 2026). In 2025 the program faced a serious safety crisis: deaths from acute liver failure tied to the shared AAVrh74 vector led the FDA to pause US shipments in July 2025, and Roche voluntarily paused ex-US shipments (July 23, 2025) in countries that reference FDA decisions, while continuing supply in independently-approving markets such as Brazil and Japan. The EMA issued a negative opinion in 2025, and Roche announced a new global Phase 3 confirmatory trial on April 16, 2026 to support ex-US use.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Roche Holding AG / Sarepta Therapeutics Inc. (this deal) | 2019 | $1.7B | 62 |
| Roche Holding AG / Chugai Pharmaceutical Co. Ltd. | 2002 | $1.4B | 100 |
| Roche Holding AG / Ventana Medical Systems Inc. | 2008 | $3.4B | 88 |
| Roche Holding AG / Corange Ltd. (Boehringer Mannheim Group) | 1997 | $11.0B | 88 |
| Roche Holding AG / Ventana Medical Systems Inc. | 2007 | $3.4B | 88 |
| Roche Holding AG / Foundation Medicine, Inc. | 2015 | $1.1B | 87 |
| Roche Holding AG / Foundation Medicine, Inc. | 2018 | $5.3B | 85 |
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More: 2019 deals · Roche Holding AG deals · Gene Therapy deals