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Skyhawk Therapeutics
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Skyhawk Therapeutics

https://www.skyhawktx.com/
Last activity: 03.03.2026
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Categories: BioTechClinicalTrialsNeurologyRNATherapeutics
Skyhawk Therapeutics is a drug discovery and development company focused on revolutionizing disease treatment with small molecules that correct RNA expression. Our founders are leading experts in small molecule therapeutics development for RNA-based disease. Our first drug candidates are targeted towards cancers and neurological conditions. The company is based in Waltham, Massachusetts. For more information, please visit: www.skyhawktx.com.
Followers
556
Followers
5.17K
Mentions
15
Location: United States
Employees: 51-200
Total raised: $48M
Founded date: 2016

Investors 4

Funding Rounds 2

DateSeriesAmountInvestors
26.06.2018-$40M-
24.01.2018Seed$8M-

Mentions in press and media 15

DateTitleDescription
03.03.2026Skyhawk Announces Australia's Therapeutic Goods Administration Has Determined SKY-0515 for Huntington's Disease Meets Eligibility Criteria for Registration via the Provisional Approval PathwayAustralia'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 H...
27.01.2026Skyhawk Therapeutics Announces Nine Month Interim Results in Patients from its Phase 1 Clinical Trial of SKY-0515 as a Treatment for Huntington's DiseaseNine-month findings show mean improvement in Composite Unified Huntington's Disease Rating Scale from baseline of +0.64 points, compared to natural history expected worsening of cUHDRS in symptomatic patients of -0.73 points over nine month...
17.09.2025Skyhawk Therapeutics Announces Positive First Interim Results in Patients from its Phase 1 Clinical Trial of SKY-0515 as a Treatment for Huntington's DiseaseSKY-0515 achieves dose-dependent reductions of mutant huntingtin (mHTT) protein, with 62% lowering at Day 84 on the 9mg daily oral dose Additional findings include dose-dependent reductions in PMS1 mRNA, excellent brain penetration, and a f...
17.06.2025Skyhawk Therapeutics Announces First Patient Dosed in Phase 2/3 FALCON-HD Trial of SKY-0515 for Huntington's DiseaseSKY-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% redu...
15.03.2025Skyhawk Therapeutics Presents at Huntington's Disease Youth Organization HDYO International Congress 2025Skyhawk presents today on its novel SKY-0515 small molecule RNA splicing modulator targeting Huntington's Disease to members of the Huntington's Disease Youth Organization, at the annual HYDO International Congress in Prague, Czech Republic...
10.12.2024Skyhawk Therapeutics Receives Australian Regulatory Approval to Extend SKY-0515 Treatment Duration in Phase 1 Huntington's Disease Patient TrialAustralian Human Research Ethics Committees approves SKY-0515 treatment for up to 12 weeks in the company's ongoing Phase 1 trial in patients with Huntington's Disease Volumetric MRI measurement is also approved as exploratory study endpoin...
26.06.2024Superlab Suisse opens 5000 square meters lab space in Basel For life sciences and biotech companies, access to affordable dedicated lab spaces is hard to come by. Labs are expensive to build and operate. A new alternative is being offered by Superlab Suisse, a leading provider of innovative laborat...
22.04.2024Ipsen and Skyhawk Therapeutics announce RNA targeting research collaboration in rare neurological diseasesIpsen enters into an option agreement to receive exclusive global rights to two candidates pursued under the collaboration Following development candidate validation, Ipsen will assume responsibility for further development and commercializ...
28.02.2024Skyhawk Therapeutics Has Advanced to the Multiple Ascending Dose Portion of its Phase 1 Study evaluating SKY-0515, a RNA-Targeting Small Molecule for Huntington's DiseaseSKY-0515 is a small molecule RNA splicing modifier developed through the company's novel SKYSTAR® platform. Having successfully advanced through single asending dose, SKY-0515 is advancing into the Multiple Ascending Dose portion of its pha...
23.10.2023Skyhawk Therapeutics Receives HREC Approval for a Phase 1 Study of its SKY-0515 RNA-Targeting Small Molecule for Huntington's DiseaseSKY-0515 is a small molecule RNA splicing modifier developed through the company's novel SKYSTAR® platform. SKY-0515's Phase 1 study will include healthy volunteers before targeting Huntington's patients. Huntington's disease is a fatal neu...
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