Vaderis Receives FDA Fast Track Designation for VAD044

Vaderis Receives FDA Fast Track Designation for 
VAD044 for the Treatment of Hereditary 
Hemorrhagic Telangiectasia

Basel, Switzerland, November 18th, 2024 – Vaderis Therapeutics AG (Vaderis), a 
clinical stage biotechnology company focusing on treatments for rare diseases 
associated with vascular malformations, today announces that the US Food and Drug 
Administration (FDA) has designated the allosteric AKT-inhibitor VAD044 a Fast Track 
product for the treatment of Hereditary Hemorrhagic Telangiectasia (HHT).
Fast Track is an FDA process designed to facilitate the development and expedite the 
review of drugs to treat serious conditions and fill an unmet medical need. The FDA 
states the purpose of Fast Track to get important new drugs to the patient earlier.
Dr. Hanny Al-Samkari, the Peggy S. Blitz Endowed Chair in Hematology/Oncology at 
Massachusetts General Hospital and Associate Professor of Medicine at Harvard 
Medical School (USA) commented, “The FDA’s decision to designate VAD044 as a Fast 
Track product for the treatment of HHT underscores its potential to be the first ever
approved treatment for this debilitating genetic disease.”
HHT, an Orphan Disease, is the second most common inherited bleeding disorder in 
the world frequently causing severe disease burden, reduced life expectancy and 
impaired Quality of Life. Despite this, there remains no approved treatment for HHT
anywhere in the world. Vaderis is developing VAD044, an oral, once-daily allosteric 
AKT-inhibitor, the first novel therapy intended specifically for the treatment of HHT.

For further information please contact:
Vaderis Therapeutics AG
Nicholas Benedict
[email protected]
www.vaderis.com