Zinger Key Points
- Biogen secures rights to commercialize zorevunersen outside North America, while Stoke leads global development and retains U.S. rights.
- Stoke receives $165 million upfront, up to $385 million in milestones, and royalties, with a Phase 3 trial set to begin in Q2 2025.
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On Tuesday, Biogen Inc. BIIB and Stoke Therapeutics, Inc. STOK collaborated to develop and commercialize zorevunersen for Dravet syndrome in all territories outside the United States, Canada, and Mexico.
Zorevunersen is an investigational antisense oligonucleotide (ASO) that targets the SCN1A gene, the underlying cause of most cases of Dravet syndrome.
Stoke recently announced plans to initiate a global Phase 3 registrational study of zorevunersen (EMPEROR) following the alignment with regulatory agencies in the United States, Europe, and Japan.
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The study is on track to initiate in the second quarter of 2025, with a pivotal data readout expected in the second half of 2027, which is anticipated to support global regulatory filings.
Stoke will continue to lead global development and retain exclusive development and commercialization rights for zorevunersen in the U.S., Canada, and Mexico.
Biogen receives exclusive rights to commercialize zorevunersen in the rest of the world. Stoke will receive an upfront payment of $165 million. The parties will share external clinical development costs for zorevunersen (30% Biogen; 70% Stoke).
Additionally, Stoke may receive up to $385 million in development and commercial milestone payments.
Stoke will also be eligible to receive tiered royalties on potential net sales in the Biogen territory, ranging from low double digits to high teens.
Stoke has also granted Biogen an option to license rights outside of the U.S., Canada, and Mexico to certain future follow-on ASO products targeting SCN1A, in exchange for separate milestone, cost sharing, and royalty considerations.
“Additionally, this collaboration provides cash flows, that when combined with Stoke’s financial position, support the company through to mid-2028,” said Edward Kaye, CEO of Stoke Therapeutics.
Price Action: At last check Tuesday, BIIB was down 0.79% at $136.24, and STOK was down 3.15% at $10.34.
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