Investigational status

“SKY-0515 is an investigational, once-daily oral medicine that is currently only available through clinical trials. It is not approved for use in any disease or in any country.” (opens the source at this quote in a new tab)

Current development phase

“The FALCON-HD pivotal program (NCT06873334 and NCT07378644) is a randomized, double-blind, placebo-controlled, dose-ranging study evaluating the pharmacodynamics, safety and efficacy of SKY-0515.” (opens the source at this quote in a new tab)

Australia: TGA provisional approval pathway eligibility and submission

“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.” (opens the source at this quote in a new tab)
“Skyhawk delivered its application for provisional approval to the TGA today.” (opens the source at this quote in a new tab)

Australia: duration of provisional registration

“Provisional registration is time-limited: it’s granted initially up to two years, with the option to extend up to a maximum of six years.” (opens the source at this quote in a new tab)
“To be clear: this is not approval.” (opens the source at this quote in a new tab)

Company-projected approval and launch timing

“Skyhawk may receive accelerated approval for SKY-0515 in Australia within the next twelve months, and in other major markets during 2027” (opens the source at this quote in a new tab)
“will prepare Skyhawk for the launch of SKY-0515 as early as 2027.” (opens the source at this quote in a new tab)

Regulatory submission: TGA provisional approval application submitted March 2026

“BOSTON, March 3, 2026 /PRNewswire/” (opens the source at this quote in a new tab)
“Skyhawk delivered its application submission to the TGA for provisional approval today.” (opens the source at this quote in a new tab)

Launch: Anticipated as early as 2027, market not specified

“Industry veteran brings more than 30 years of experience launching therapies for neurological diseases, including Huntington's disease, and will prepare Skyhawk for the launch of SKY-0515 as early as 2027.” (opens the source at this quote in a new tab)

United States, Canada, and United Kingdom: clinical trial authorizations

“announces it has received additional regulatory approvals to open its Phase 2/3 FALCON-HD (004-ANZ and 004-WW) pivotal trial, with an IND acceptance in the United States and CTA acceptances in each Canada and the United Kingdom.” (opens the source at this quote in a new tab)

Global trial footprint

“The worldwide Phase 2/3 FALCON-HD-004-WW pivotal study is now active across more than ten countries and twenty clinical sites. SKY-0515's Phase 1/2 and FALCON-HD pivotal studies have now enrolled more than 200 patients.” (opens the source at this quote in a new tab)

FDA or EMA marketing application, orphan, fast track, breakthrough therapy, or PRIME designations

No evidence found.