Stoke Therapeutics Announces Collaboration Agreement with Biogen for Zorevunersen Development

Stoke Therapeutics, a Delaware corporation, made a significant announcement on February 14, 2025. In a recent 8-K filing with the Securities and Exchange Commission, Stoke Therapeutics disclosed the initiation of a License and Collaboration Agreement with Biogen International GmbH. This agreement focuses on the development and commercialization of zorevunersen (STK-001) and other potential products directed to SCN1A, particularly for Dravet syndrome, a rare form of genetic epilepsy.

As per the newly formed agreement, Stoke Therapeutics granted Biogen an exclusive, royalty-bearing license for zorevunersen and related backup antisense oligonucleotides (ASOs) in territories worldwide outside of the United States, Canada, and Mexico. Additionally, Biogen has the option to exercise a license for certain future follow-on ASOs aimed at SCN1A.

In exchange for these rights, Biogen is to pay an upfront sum of $165,000,000 to Stoke Therapeutics. The two entities will share external development costs, with Stoke covering 70 percent. Stoke is also poised to receive potentially up to $385,000,000 in milestone payments based on specific development and commercial achievements, along with tiered royalties ranging from low double digits to high teens on future net sales in the Biogen Territory.

A joint steering committee will oversee the zorevunersen development and commercialization, comprising an equal number of representatives from Stoke Therapeutics and Biogen. The agreement will remain in effect until royalty terms expire, at which point the license for the product in a specific country becomes fully paid-up, royalty-free, perpetual, and irrevocable.

In a related press release on February 18, 2025, Stoke Therapeutics and Biogen jointly announced their collaboration. Stoke highlighted that the collaboration, along with its current financial position and the receipt of upfront payments from Biogen, is expected to support operations until mid-2028. Stoke plans to commence the Phase 3 Emperor study in the second quarter of 2025, with anticipated data revealing in the latter half of 2027.

The 8-K filing also included forward-looking statements, emphasizing potential risks and uncertainties associated with the collaboration, the development of zorevunersen, and other aspects of the agreement. Stoke Therapeutics made clear its intention to conduct research, obtain regulatory approval, and eventually commercialize zorevunersen, aiming to address the unmet needs in Dravet syndrome treatment.

For more detailed information regarding the collaboration and financial implications, interested parties are referred to the full text of the Agreement, which will be filed as an exhibit to Stoke Therapeutics’ Quarterly Report on Form 10-Q for the quarter ending March 31, 2025.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Stoke Therapeutics’s 8K filing here.

Stoke Therapeutics Company Profile

Stoke Therapeutics, Inc, an early-stage biopharmaceutical company, develops medicines to treat the underlying causes of severe genetic diseases in the United States. The company utilizes its proprietary targeted augmentation of nuclear gene output to develop antisense oligonucleotides to selectively restore protein levels.