Biogen and Stoke Therapeutics Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome - Candlesense

BIIB Clinical trials

Biogen and Stoke Therapeutics Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome

Published August 11, 2025 at 11:00 AM

– Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period –

Related Questions

How will the sham‑controlled design impact the perception of efficacy and market adoption? What are the risks of trial failure or safety concerns, and how could they impact the share price? How does this partnership with Stoke Therapeutics affect Biogen’s financials and pipeline valuation? What are the reimbursement and pricing expectations for a disease‑modifying therapy in a rare, pediatric seizure disorder? What are the competitive landscape and pipeline of other companies targeting Dravet syndrome, and how might this trial affect Biogen’s competitive positioning? What is the anticipated impact on Biogen’s earnings guidance and future cash flow projections if the trial succeeds? How will the initiation of the Phase 3 EMPEROR study affect Biotech's (BIIB) stock price in the short term? What is the anticipated timeline for results from the EMPEROR study and subsequent FDA approval? How does zorevunersen’s mechanism of action compare to other treatments for Dravet syndrome currently in development or on the market? What is the expected market size and revenue potential if zorevunersen gains FDA approval? What are the primary endpoints and statistical power of the EMPEROR study, and how might they affect the probability of success? What are the potential regulatory hurdles or requirements for a disease‑modifying therapy in Dravet syndrome?

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