• Gilead secured FDA accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg, the first US-cleared treatment for chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis.
• The decision was based on Phase 3 MYR301 results showing reductions in HDV RNA with ALT normalization at Week 48 versus a delayed-treatment control group.
• Ongoing approval remains contingent on confirmatory evidence of clinical benefit.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Gilead Sciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260522569258) on May 22, 2026, and is solely responsible for the information contained therein.