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

2026-03-02 - 18:37

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 Huntington’s disease meets TGA eligibility criteria for registration via the provisional approval pathway. Skyhawk delivered its application for provisional approval to the TGA today. More than