Catalyst overview
Research summary
This catalyst tracks a Approved update for Bulevirtide (Hepcludex®) in Hepatitis Delta Virus. The expected timing is based on the latest available company guidance and may change.
Studies: [MYR301, MYR 203, MYR204]. BLA submitted Q4 2021 and CRL Oct 2022 regarding the manufacture and delivery of bulevirtide. 5/4/23- Full marketing authorization in EU. Encouraging 96wk data at EASL '23. MYR204 Data at AASLD '23 on 11/14/23. New data at CROI '24. Final Ph2b MYR204 & MYR301 results at EASL '24 from June 5-8th. Presentation at AASLD '24. 05/13/26:- EASL 2026: MYR204/MYR301 integrated analyses report outcomes through 96 weeks. 05/22/26:- FDA accelerated approval granted for Hepcludex for chronic HDV. Confirmatory long-term outcomes study initiated.
Verification
Confirm timing and program details against the company announcement or filing.