Skyhawk Announces Australia's Therapeutic Goods Administration Has Determined SKY-0515 for Huntington's Disease Meets Eligibility Criteria for Registration via the Provisional Approval Pathway
Australia's Therapeutic Goods Administration (TGA), responsible for approval of the safety, quality, and efficacy of therapeutic goods, has determined that Skyhawk's SKY-0515 orally-administered small molecule therapy for the treatment of...
Skyhawk Therapeutics Announces First Patient Dosed in Phase 2/3 FALCON-HD Trial of SKY-0515 for Huntington's Disease
SKY-0515 is an oral small molecule designed to reduce the production of both huntingtin (HTT) and PMS1 proteins—two key drivers of HD pathology Initiation of the FALCON-HD trial follows promising Phase 1 results demonstrating up to 72% reduction in...