Skyhawk Therapeutics Expands Huntington's Disease Trial to US, Canada, UK
Skyhawk Therapeutics has expanded its pivotal FALCON-HD clinical trial for SKY-0515 in Huntington's disease with new regulatory approvals in the United States, Canada, and the United Kingdom, broadening its global reach.
Boston, MA – July 14, 2026 – Skyhawk Therapeutics, a clinical-stage biotechnology company, has announced the expansion of its pivotal Phase 2/3 FALCON-HD clinical trial for its Huntington's disease candidate, SKY-0515. The company has received regulatory approval from the U.S. Food and Drug Administration (FDA) to initiate the trial in the United States, along with Clinical Trial Application (CTA) acceptances from Canadian and UK regulatory authorities.
The expansion adds the U.S., Canada, and the United Kingdom to the ongoing global study of SKY-0515, an orally administered small molecule therapy. Previously, the trial enrolled participants in Australia and New Zealand. The trial now involves over ten countries and more than twenty sites, with over 175 patients enrolled in the Huntington's disease study.
According to Skyhawk, SKY-0515, developed using the company's proprietary SKYSTAR® platform, has shown promising results in early patient data. Twelve months of treatment reportedly demonstrated a 69% reduction in mHTT protein and a 26% reduction in PMS1 protein. Improvements in cUHDRS scores were also observed compared to natural history declines.
Huntington's disease is a rare, inherited neurodegenerative disorder for which there are currently no approved therapies that slow or stop its progression. SKY-0515 is designed to reduce the production of toxic huntingtin proteins. The company also plans to advance several other programs utilizing its SKYSTAR platform into clinical development by the end of 2027.