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STOK 資訊
STOK 事件
Stoke Therapeutics Presents STK-002 Data at AAO Meeting
Stoke Therapeutics announced two presentations of data for STK-002 at the American Academy of Ophthalmology, AAO, 2026 Annual Meeting, taking place October 9-12 in New Orleans. STK-002 represents a novel approach to Autosomal Dominant Optic Atrophy. ADOA natural history findings and preclinical data for STK-002 support the ongoing Phase 1 OSPREY study and the disease-modifying potential of STK-002 in ADOA. Dose escalation is ongoing in the OSPREY study, with the first two dose cohorts now complete and the third cohort expected to complete by the end of 2026. Cohorts three and four have the potential to reach therapeutic levels of dosing, with initial safety and efficacy data from these latter cohorts anticipated in the first half of 2027.
Stoke Therapeutics Presents STK-002 Data at AAO 2026 Meeting
Stoke Therapeutics announced two presentations of data for STK-002 at the American Academy of Ophthalmology, AAO, 2026 Annual Meeting, taking place October 9-12 in New Orleans. TK-002 is an investigational medicine designed to target the underlying cause of Autosomal Dominant Optic Atrophy, ADOA. There are currently no approved treatments for ADOA. Dose escalation is continuing in the Phase 1 OSPREY study of STK-002 in people with ADOA, with the first two dose cohorts now complete and the third cohort expected to complete by year-end 2026. Cohorts three and four are expected to achieve therapeutic levels of dosing, with initial safety and efficacy data from these latter cohorts anticipated in the first half of 2027.
Stoke Therapeutics Completes Meeting with FDA, Plans NDA Submission in 2027
Stoke Therapeutics announced the completion of a successful meeting with the U.S. Food and Drug Administration, FDA, intended to align on key aspects of the Company's planned submission of a New Drug Application, NDA, for zorevunersen. The meeting provided an opportunity to discuss the 5 years of clinical safety and efficacy data from the Phase 1/2a and ongoing open-label extension, OLE, studies of zorevunersen and to obtain feedback on the planned NDA submission, including timing, data to be included and the analysis of Vineland-3 data, a key secondary endpoint in the Phase 3 EMPEROR study. Following the discussion with the FDA, Stoke now plans to use a multicomponent assessment of four prespecified Vineland-3 subdomains to evaluate changes in cognition and behavior in the Phase 3 EMPEROR study. The Company plans to continue actively engaging with the FDA and to submit data throughout the first half of 2027 to support rapid completion of the NDA submission following the Phase 3 readout anticipated in the third quarter of 2027. With these data, the Company plans to complete the U.S. NDA submission in the second half of 2027 to support a potential U.S. approval and launch of zorevunersen in early 2028.
Stoke Therapeutics Appoints Bo Cumbo to Board of Directors
Stoke Therapeutics "announced the appointment of Bo Cumbo to its Board of Directors. Concurrent with Mr. Cumbo's appointment, Edward Kaye, M.D., has retired from his role as a Director on Stoke's Board. Dr. Kaye has served on Stoke's Board of Directors since 2017 and was the Chief Executive Officer of the Company from 2017 to March 2025. Dr. Kaye will continue to advise Stoke's Board of Directors through the transition." "Bo's track record of commercializing medicines for rare pediatric diseases will further enhance the capabilities of our Board as we prepare to deliver zorevunersen to people with Dravet syndrome following potential FDA approval in early 2028," said Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics. "Bo also brings experience leading organizations through significant growth, which will help position Stoke for long-term success as we build our company for the future. We are very pleased to welcome Bo to the Board."
Stoke Therapeutics and Biogen Present Dravet Syndrome Data in Athens
"Stoke Therapeutics (STOK) and Biogen Inc. (BIIB) announced presentations of data at the 16th European Epilepsy Congress taking place September 5-9 in Athens, Greece. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. Dravet syndrome is a severe developmental and epileptic encephalopathy, DEE, characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Data presented at EEC represent more than 5 years of clinical experience with zorevunersen in patients with Dravet syndrome, including two Phase 1/2a and ongoing open-label extension studies. Four-year OLE results showed substantial and durable reductions in seizures and continuing improvements in cognition and behavior. A new exploratory sub-analysis also showed substantial reductions in the most severe seizure types, which are the leading risk factor for sudden unexpected death in epilepsy. SUDEP is the primary cause of premature death in Dravet syndrome2, and up to 20% of children and adolescents with the disease die before reaching adulthood3. An additional sub-analysis presented at EEC demonstrated substantial improvements in quality of life through 28 months in the OLEs. Zorevunersen continues to be generally well tolerated in the OLEs. The global, pivotal Phase 3 EMPEROR study is underway to evaluate the efficacy and safety of zorevunersen. Enrollment has completed in the planned primary analysis population, which will evaluate zorevunersen compared to sham administered via lumbar puncture (LP) in 162 patients enrolled in the U.S., U.K. and Japan. A Phase 3 data readout is anticipated in the third quarter of 2027 to complete the planned rolling New Drug Application to the U.S. Food and Drug Administration in the second half of 2027. Enrollment in Europe has also completed with 34 participants enrolled."
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