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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Pharma Stocks on the Verge of a Breakthrough: Earnings May Propel Them Forward.
- Pharmaceutical Stocks Performance: Pharmaceutical stocks have recently reached new highs in the market.
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Biogen Receives FDA Breakthrough Therapy Designation for Litifilimab
- FDA Breakthrough Therapy Designation: Biogen's litifilimab (BIIB059) has received FDA Breakthrough Therapy Designation for treating cutaneous lupus erythematosus (CLE), indicating the FDA's recognition of the drug's potential in addressing serious diseases and potentially expediting its market entry.
- Clinical Trial Data Support: Results from the Phase 2 LILAC study demonstrate that litifilimab significantly reduces skin disease activity in CLE patients compared to placebo, highlighting its potential to improve patient quality of life.
- Urgent Market Need: Current standard treatments for CLE include topical steroids and antimalarials, but there are no targeted therapies available, making litifilimab's development crucial to meet the urgent demand for effective treatments among patients.
- Future Research Plans: Biogen is advancing the AMETHYST Phase 3 study, with data readout expected in 2027, which, if successful, could provide a new therapeutic option for millions of CLE patients, further solidifying Biogen's leadership in the biopharmaceutical sector.









