Stoke Therapeutics Accelerates EMPEROR Study Enrollment Timeline to Q2 2026
Stoke Therapeutics (STOK) announced accelerated timelines for the completion of enrollment and a Phase 3 data readout from the EMPEROR study. Completion of enrollment of 150 patients is now expected in the second quarter of 2026. This enrollment progress puts the Phase 3 EMPEROR study on track for a data readout in mid-2027 that is anticipated to support the submission of a New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA. The Company plans to initiate a rolling NDA submission in the first half of 2027. In addition, as part of zorevunersen's Breakthrough Therapy Designation, a multidisciplinary meeting was held with the FDA to discuss the ongoing clinical development of zorevunersen, including the exploration of potential expedited regulatory pathways. No immediate changes to the zorevunersen development program were agreed to at the meeting. Zorevunersen is in development with Biogen (BIIB)
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- Priority Review Approval: The subcutaneous autoinjector formulation (SC-AI) of LEQEMBI® received Priority Review from China's National Medical Products Administration in January 2026, which is expected to expedite its market launch, thereby providing a more convenient treatment option for Alzheimer's disease patients.
- Home Administration Convenience: The 500 mg autoinjector allows for a once-weekly home administration, replacing the current biweekly intravenous infusions in hospitals, which is anticipated to significantly enhance patient adherence and quality of life.
- Significant Market Potential: Eisai estimates that there were 17 million patients with mild cognitive impairment or mild dementia in China in 2024, a number expected to rise with the aging population, indicating a growing demand for LEQEMBI® in the market.
- New Insurance Coverage Policy: LEQEMBI® has been included in the “Commercial Insurance Innovative Drug List” effective January 2026, which will encourage commercial insurance companies to develop insurance products for it, further enhancing patient accessibility and market penetration.
- Priority Review Approval: The subcutaneous autoinjector formulation (SC-AI) of LEQEMBI® received Priority Review from China's National Medical Products Administration in January 2026, aimed at accelerating the development and launch of clinically valuable new medicines, which is expected to shorten the assessment period and enhance patient access to treatment.
- Home Administration Convenience: If approved, the 500 mg SC-AI will allow patients to self-administer a weekly injection at home, replacing the current biweekly intravenous administration in hospitals, significantly improving patient convenience and alleviating healthcare resource burdens associated with IV dosing.
- Significant Market Potential: Eisai estimates that there were 17 million patients with mild cognitive impairment or mild dementia in China in 2024, a number projected to rise with the aging population, and the home administration option of LEQEMBI® will provide more flexible treatment choices for these patients.
- Insurance Coverage Expansion: LEQEMBI® has been included in the
- Strong Financial Performance: Biogen's Q4 2025 report revealed total revenue of nearly $2.28 billion, down 7% year-over-year, yet surpassing analyst expectations of $2.21 billion, demonstrating the company's resilience in challenging market conditions.
- Declining Net Income: Non-GAAP net income fell to $294 million ($1.99 per share), a significant drop from over $502 million a year ago, reflecting increased competitive pressures impacting profitability.
- Product Revenue Decline: Product revenue decreased by 9% to $1.67 billion, with the largest drug category, multiple sclerosis (MS) treatments, experiencing a 14% year-over-year decline to $917 million, highlighting the impact of generics and biosimilars on sales.
- Positive 2026 Outlook: Biogen anticipates mid-single-digit revenue decline for 2026, with adjusted net income projected between $15.25 and $16.25 billion, exceeding the average analyst estimate of $14.92 billion, indicating growth potential in its new product lines.
- Strong Financial Performance: Biogen's 2025 earnings report revealed total revenue of $2.28 billion, down 7% year-over-year, yet surpassing analyst expectations of $2.21 billion, indicating resilience amid challenges.
- Significant Net Income Decline: The company's non-GAAP net income fell sharply to $294 million ($1.99 per share) from over $502 million a year ago, reflecting increased market competition impacting profitability.
- Product Revenue Decline: Product revenue decreased by 9% to $1.67 billion, with multiple sclerosis treatment sales dropping 14% year-over-year to $917 million, highlighting the competitive pressure from generics and biosimilars.
- Positive Future Outlook: Biogen anticipates mid-single-digit revenue decline for 2026, with adjusted net income projected between $15.25 and $16.25 billion, exceeding the average analyst estimate of $14.92 billion, showcasing potential in new drug development and market expansion.

- Performance Exceeds Expectations: Biogen reported a non-GAAP diluted EPS of $1.99 for Q4 2025 and $15.28 for the full year, both surpassing expectations, indicating strong growth from its new product portfolio and market performance, with total revenue reaching $9.9 billion, up 2% year-over-year.
- Growth Product Success: The company’s growth products generated $3.3 billion in revenue for 2025, a 19% increase, with Q4 contributing $800 million, demonstrating significant market acceptance of new products like VUMERITY and LEQEMBI, thereby enhancing the company's competitive position.
- Significant Pipeline Progress: Management highlighted the pipeline advancements as the
- Revenue Beat: Biogen reported fiscal 2025 revenues of $2.28 billion, surpassing the consensus estimate of $2.20 billion, despite a 7% year-over-year decline, demonstrating resilience amid market challenges.
- Strong Growth Products: Revenue from growth products increased by 19% year-over-year, successfully offsetting declines in multiple sclerosis product revenues, indicating effective strategies in drug development and market promotion.
- Market Performance: Leqembi collaboration revenue reached $47 million, with in-market sales of approximately $134 million, up 54%, reflecting strong demand for the Alzheimer's drug in the market.
- Optimistic Outlook: Biogen expects fiscal 2026 earnings between $15.25 and $16.25 per share, exceeding the consensus of $14.92, and while multiple sclerosis product revenues are projected to decline, increases in growth product revenues are expected to partially offset this impact.










