Biopharma · FDA Approvals · Stock
Enanta Pharmaceuticals Inc is a biotechnology company that uses a chemistry-based drug discovery approach to develop small-molecule candidates for virology and immunology applications. It focuses on Virology and Immunology. Its active development programs in virology are focused on respiratory syncytial virus, or RSV, …
Assets on file: glecaprevir/pibrentasvir, zelicapavir
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Enanta doses first patient in RESOLVE Phase 2b/3 of zelicapavir for high-risk adult RSV
Enanta initiated the global RESOLVE Phase 2b/3 trial of oral zelicapavir (800 mg QD x7d) in high-risk adult outpatients with RSV; the Phase 2b portion (n>=200) will confirm effect size on symptom resolution (primary) and hospitalization (key secondary) with topline data expected in 2027.
Enanta to Present Zelicapavir Phase 2 Data at IDWeek 2026
Enanta will present Phase 2 data for zelicapavir (oral N-protein inhibitor) showing decreases in time to RSV symptom resolution, hospitalization, and viral load in high-risk adults at IDWeek on October 22, 2026. This is a poster presentation in the Novel Agents session.
Enanta: AbbVie MAVIRET approved by EC for acute HCV
European Commission approved MAVIRET (glecaprevir/pibrentasvir) for acute HCV in adults and children ≥3 years, making it the only EU-approved therapy for both acute and chronic HCV. The approval was supported by the Phase 3 M20-350 study showing 96.2% SVR12 in the ITT population after an 8-week regimen.
Enanta advances zelicapavir Phase 3 enabling activities with FDA alignment targeted Q2 2026
Enanta is conducting Phase 3 enabling activities for zelicapavir, including FDA discussions, with the goal of aligning on an adult Phase 3 trial design and overall registration path in the second quarter of 2026. The company also continues to explore potential business development opportunities related to its RSV program.
Enanta reports positive Phase 2b RSVHR topline for zelicapavir
The RSVHR Phase 2b study met key secondary endpoints, showing clinically meaningful faster symptom resolution and lower hospitalization rates versus placebo in high-risk adults with RSV. These Phase 3-enabling results support further development of zelicapavir as the first antiviral with demonstrated benefit in this outpatient population.
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