SKY-0515

Name: SKY-0515 in Huntington's disease: Indication
Published: 2026-09-16T18:00:43-04:00

Huntington's disease

Manufacturer: Skyhawk Therapeutics
Regulatory submission: TGA provisional approval application submitted March 2026
Launch: Anticipated as early as 2027, market not specified
Last updated: October 1, 2026

Section

Product information and disease description Product description Product information

Indication

2 evidence topics · 2 sources

Indication under regulatory review in Australia

“the Company'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.” (opens the source at this quote in a new tab)

Population studied in pivotal trials

“FALCON-HD 004-ANZ enrolled 144 participants with Stage 2 and Stage 3 HD across sites in Australia and New Zealand. Enrollment is complete.” (opens the source at this quote in a new tab)