Skyhawk expands FALCON-HD trial to US, UK, Canada
Analysis based on 8 articles · First reported Jul 14, 2026 · Last updated Jul 14, 2026
The expansion of the pivotal trial increases the likelihood of SKY-0515 reaching the market, potentially addressing a large unmet need in Huntington's disease. Positive Phase 1/2 data and regulatory approvals in multiple countries may boost investor confidence in Skyhawk Therapeutics.
Skyhawk Therapeutics announced on July 14, 2026 that it has received regulatory approvals to expand its Phase 2/3 FALCON-HD pivotal trial for SKY-0515 in Huntington's disease to the United States, Canada, and the United Kingdom. The trial now includes over ten countries and more than twenty sites, with over 175 patients enrolled. SKY-0515's Phase 1/2 enrollment is complete, showing 69% reduction in mHTT, 26% reduction in PMS1, and cUHDRS improvements from baseline. The drug is an orally administered small molecule RNA splicing modifier designed to reduce mHTT and PMS1 proteins. Huntington's disease is a rare, fatal neurodegenerative disorder with no approved disease-modifying therapies. Skyhawk plans to advance additional therapies from its SKYSTAR platform into clinical development by end of 2027.
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