Gilead Submits NDA for Bulevirtide, First Potential HDV Treatment, Backed by Phase 3 MYR301 Data
Gilead Sciences submitted a new drug application to the U.S. Food and Drug Administration for bulevirtide 10 mg to treat chronic hepatitis delta virus infection in adults, the company announced Thursday. The submission was supported by Phase 3 MYR301 study data demonstrating the drug’s efficacy and safety as a viral entry inhibitor, according to Gilead officials.
The new drug application for bulevirtide 10 mg targets the treatment of chronic hepatitis delta virus (HDV) infection in adults and is supported by data from the pivotal Phase 3 MYR301 study, according to Gilead officials.
The MYR301 trial (NCT03852719) evaluated the safety and efficacy of the drug as a viral entry inhibitor, with results integrated alongside long-term data from the MYR204 study (NCT03852433), providing a comprehensive clinical evidence package for the submission.
Gilead acquired bulevirtide and the MYR GmbH portfolio in 2021 and has since implemented process improvements to address prior regulatory concerns. The U.S. Food and Drug Administration issued a complete response letter (CRL) on Oct. 27, 2022, citing manufacturing issues related to the biologics license application for bulevirtide in adults with HDV and compensated liver disease, records show. Gilead’s Chief Medical Officer, Dr. Merdad Parsey, expressed confidence in the drug’s profile and confirmed the company’s commitment to ongoing discussions with the FDA to resolve manufacturing and delivery challenges.
The FDA has granted bulevirtide Breakthrough Therapy and Orphan Drug designations for the 10 mg subcutaneous formulation, recognizing the unmet medical need in chronic HDV infection, according to regulatory filings. These designations were awarded prior to the 2022 CRL and remain in effect for the current application. The NDA is listed among FDA decisions expected in the first half of 2026, with March 2026 cited as a potential review period, although no specific Prescription Drug User Fee Act (PDUFA) date has been confirmed, sources said.
Bulevirtide has not yet received approval anywhere globally, underscoring the investigational status of the drug pending regulatory review. Gilead plans to present additional MYR301 and MYR204 data at scientific meetings, including The Liver Meeting 2025 scheduled for Nov. 7-11 in Washington, D.C., according to conference abstracts and company statements. These presentations will provide further insight into the long-term safety and efficacy profile of bulevirtide in chronic HDV patients.
The submission of bulevirtide aligns with Gilead’s broader commitment to liver disease innovation. The company’s portfolio includes treatments for primary biliary cholangitis (PBC) and viral hepatitis, with recent regulatory progress such as Health Canada’s approval of seladelpar (Livdelzi) on Oct. 21, 2025, following its marketing authorization earlier that year. Gilead officials noted that data from bulevirtide and other liver disease programs will be featured in more than 35 abstracts at the upcoming Liver Meeting.
The MYR301 study was designed to assess bulevirtide’s efficacy and safety in adults with chronic HDV infection, a patient population with limited treatment options. The integration of MYR204 and MYR301 data supports the NDA submission with robust clinical evidence, according to Gilead. The company continues to engage with regulatory authorities to address all outstanding requirements and advance bulevirtide toward potential approval.
Records indicate that the NDA submission represents a key step following prior regulatory interactions and manufacturing improvements. Gilead’s efforts to resolve the FDA’s previous concerns reflect ongoing collaboration aimed at bringing the first potential HDV treatment to market. The FDA’s review and decision process will determine the next phase in bulevirtide’s clinical development and availability for patients with chronic hepatitis delta virus infection.
