Biotech Values

[DewDiligence]

GILD’s Hepludex for HDV gets CRL due to CMC issues:

https://www.gilead.com/news-and-press/company-statements/gilead-receives-complete-response-letter-from-us-fda-for-bulevirtide-for-the-treatment-of-adults-with-hepatitis-delta-virus

Hepludex is the drug GILD picked up in the MYR DmbH acquisition in 2020 (#msg-160065889).

HDV, which is essentially a subtype of HBV, has no fully approved treatments, although Hepludex has a conditional approval in the EU.