Aligos Therapeutics confirmed that its independent Data Safety Monitoring Board approved the continuation of the Phase 2 B‑SUPREME study for pevifoscorvir sodium and recommended expanding the sample size for the HBeAg‑negative cohort to strengthen statistical power.
The company also reported that the U.S. Food and Drug Administration granted pevifoscorvir sodium Fast‑Track designation, a status that enables more frequent FDA interactions and may accelerate review if the drug demonstrates superior antiviral activity compared with the standard‑of‑care tenofovir disoproxil fumarate. The designation was based on 96‑week Phase 1 data presented at The Liver Meeting 2025.
B‑SUPREME is Aligos’ most advanced program and a potential source of partnership or acquisition value. The Fast‑Track status signals regulatory confidence and could improve investor perception, opening avenues for future financing or collaboration before the company’s projected cash runway depletes in Q3 2026.
The Fast‑Track designation reflects the company’s progress in addressing a significant unmet need in chronic hepatitis B, positioning pevifoscorvir sodium as a promising candidate that could reshape treatment options if it continues to demonstrate robust efficacy and safety in the expanded Phase 2 cohort.
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