FDA grants accelerated approval to Hepcludex® — originally developed by HTGF portfolio company MYR GmbH

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Gilead Sciences’ Hepcludex® (bulevirtide gmod) as the first and only treatment for chronic Hepatitis Delta Virus (HDV) infection in the United States. HDV is considered the most severe form of viral hepatitis.

Hepcludex was originally developed by MYR GmbH, a life science startup backed by HTGF at its earliest stage. We congratulate Gilead Sciences on this approval and are grateful for their continued development work and market-leading expertise in hepatology.

Dr. Bernd Goergen, Partner at HTGF:
“While it takes a lot of stamina and patience to bring a truly novel drug to the market, this milestone rewards all our efforts as an early-stage investor in life sciences. Bringing innovative therapies for serious diseases to patients and to market — that is what drives us. We are happy and grateful for Gilead’s continued development work with the FDA and their market-leading expertise in hepatology, without which this progress would barely have been possible”

Dr. Achim Plum, Managing Director at HTGF:
“MYR was HTGF’s first unicorn and the FDA approval of Hepcludex shows what that milestone truly means: that an innovation we believed in early is now actually reaching patients. That is exactly why we invest.”

• Read the full press release from Gilead Sciences 
• Read the FDA announcement