Skyhawk Therapeutics

06/01/2026

We are excited to announce this morning the twelve-month Phase 1 / 2 data for Skyhawk’s SKY-0515 small molecule splicing modifier for Huntington’s disease! Press release is here: https://social.skyhawktx.com/m/RZzSPMnQoe

05/15/2026

Today is May 15th — International Huntington's Disease Awareness Day — and for our team at Skyhawk Therapeutics, this date carries a meaning that's close to our hearts.
We're honored to share this from the Huntington's Disease Society of America and add our voice to the movement. HD is a fatal, hereditary disease that still has no approved disease-modifying treatment — and every family living with that reality deserves to be seen and supported.
If HD has touched your life, please know you are not alone. And if you'd like to learn more or get involved, visit hdsa.org. 💜
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04/22/2026

Skyhawk Therapeutics was proud to exhibit at the American Academy of Neurology Annual Meeting 2026. We are grateful to everyone who stopped by our booth and engaged with us on the work we are doing in diseases like Huntington disease.

Want to learn more about Huntington disease? Check out this clip from AAN 2026 featuring Victor Sung, MD of the UAB Huntington's Disease Clinic: https://social.skyhawktx.com/m/YBfqOGCnEt

04/14/2026

Earlier this year, we had the opportunity to connect with our LATAM partners as we
prepared to bring the Falcon-HD clinical trial to Latin America

It was a meaningful time spent with patient advocates, partners, and colleagues—
building relationships and aligning on how we can better support patients and families
affected by Huntington’s disease.

As clinical trial sites continue to come online, we’re excited to keep advancing this
important work together.

04/13/2026

Today, we’re asking our community to come together and take action. On April 13, join HDSA’s Day of Action and help us raise our collective voice for families impacted by Huntington’s disease. Your voice matters, and together, we can show Congress that our community is engaged, united, and cannot be ignored.

There are simple ways to take action:
Submit a Letter to the Editor to your local newspaper.
Call your Member of Congress.
Send an email from your personal email address.
Share this message on social media to help grow the movement.

Real change starts when people speak up. Join us, take action, and help make sure the HD community is heard. Visit https://social.skyhawktx.com/m/T7sPphNbtY to Take Action Today!

03/13/2026

Excited to be part of this!

🔬 Faisons le point sur la recherche !

L'Association Huntington France vous invite à un webinaire d'information dédié au médicament candidat SKY-0515 développé par Skyhawk Therapeutics. 🧬

Actuellement en phase clinique 2/3, ce traitement a été conçu avec un objectif majeur : réduire la fabrication de la protéine Huntingtine mutante. Mais où en est-on exactement ? Que disent les essais en cours ?

Rejoignez-nous pour en discuter et poser vos questions avec Hubert Aviolat (administrateur AHF) et nos experts invités.

📅 Jeudi 19 mars 2026
🕕 De 18h à 19h
💻 En ligne

👉 Retrouvez le programme complet et toutes les informations de connexion ici : https://huntington.fr/jeudi-19-mars-18h-a-19h-webinaire-ce-que-lon-sait-du-medicament-candidat-sky-0515-de-skyhawk-therapeutics/

Partagez cette information autour de vous, la recherche avance et il est essentiel de s'informer ensemble ! 🤝

02/25/2026

Join us for an informative webinar on Sky-0515 that will go over the what, when and where of our upcoming trial + a QA after.

Buenas tardes, APAEH, los invita a presenciar esta reunión informativa sobre el próximo ensayo a realizarse en Argentina entre otros paises de America Latina.
Estimados representantes de asociaciones de pacientes y familias afectadas por la enfermedad de Huntington en América Latina:

Nos dirigimos a ustedes para invitarlos a una presentación virtual que se llevará a cabo el viernes 27 de febrero a las 7:00 p.m. (hora de Argentina, Brasil y Chile)
(4:00 p.m. Colombia · 5:00 p.m. Perú · 3:00 p.m. México).

Es un gran placer, en nombre de Skyhawk Therapeutics y Factor-H, invitarlos a esta primera presentación informativa virtual sobre SKY-0515 y el estudio Falcon-HD en América Latina.

La presentación abordará:

• Una descripción general de SKY-0515 y su mecanismo de acción
• Una actualización sobre los datos recientes del estudio de Fase 1 en Australia y Nueva Zelanda
• Una visión general de los ensayos clínicos en curso, incluido el estudio Falcon-HD de Fase 2/3 en América Latina
• Cómo obtener más información sobre el estudio y explorar la posibilidad de participar
• Una sesión en vivo de preguntas y respuestas con un experto de Skyhawk para la comunidad de EH

A continuación, encontrarán el enlace de Zoom para la reunión:

https://us06web.zoom.us/j/85148959672?pwd=2U0SbJCt1WN86JcOEWZiY0vLAeJqEP.1

ID de la reunión: 851 4895 9672
Código de acceso: 886719

01/31/2026

Glad to share coverage from The Globe and Mail on our HD trial

Newswire.ca Press Release.

01/31/2026

We are grateful to our incredible advocacy partner the Huntington’s Australia for sharing this important story about Skyhawk’s SKY-0515 FALCON-HD trial for Huntington’s disease.

📢 Research update: SKY-0515 Phase 1 Results

We're starting 2026 with some encouraging news to share.

Today, Skyhawk Therapeutics announced positive results from their Phase 1 study of SKY-0515, an investigational once-daily oral medicine for Huntington's disease.

Here's what was reported:
✅ The drug was generally well tolerated
✅ 62% reduction in mutant huntingtin protein at the higher dose
✅ The medicine was confirmed to reach the brain
✅ Small improvements observed on clinical assessments

These are early but meaningful steps. The Phase 2/3 FALCON-HD trial is now enrolling at sites in Australia and New Zealand.

We know how much hope news like this brings, and also how important it is to be cautious with early-stage research. We're here if you have questions.

📄 Read more on: https://huntingtonsaustralia.au/skyhawk-update/

01/31/2026

We are grateful to our incredible advocacy partner the Huntington’s Disease Association of Auckland, and New Zealand’s TVNZ, for sharing this important story about Skyhawk’s SKY-0515 FALCON-HD trial for Huntington’s disease.