Pharma BD Deal Intelligence

Roche Holding AG / Sarepta Therapeutics Inc.

2019 · Licensing/Option · $1.7B · Complete

CALLED IT — OFF BY 21
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The coverage arc

Dec 23, 2019 STAT News Bullish

Sarepta sells international rights to Duchenne gene therapy SRP-9001 to Roche for $1.15B upfront.

Jul 23, 2025 BioPharma Dive - Roche pauses ex-US Elevidys shipments Bearish

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…

Apr 16, 2026 BioPharma Dive - Roche new Elevidys Phase 3 after EU setback Neutral

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.

Key facts

Related deals — scored

DealYearValueOutcome
Roche Holding AG / Sarepta Therapeutics Inc. (this deal)2019$1.7B62
Roche Holding AG / Chugai Pharmaceutical Co. Ltd.2002$1.4B100
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Roche Holding AG / Corange Ltd. (Boehringer Mannheim Group)1997$11.0B88
Roche Holding AG / Ventana Medical Systems Inc.2007$3.4B88
Roche Holding AG / Foundation Medicine, Inc.2015$1.1B87
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