Enanta Pharmaceuticals

Enanta Pharmaceuticals will start a regulatory Phase‑2b/3 study of zelicapavir in high‑risk adults in Q4 2026 and expects topline Phase‑2b data in 2027. The Phase‑2b will begin with at least 200 patients; the Phase‑3 sample is planned to be about 660 participants. The primary endpoint is time to full resolution of 13 RSV symptoms; an important secondary endpoint is hospitalization rate. For pediatric patients, Enanta plans a Phase‑2b study in Q3 2026 with approximately 150 children (28 days to 36 months). The decision follows a successful end‑of‑Phase‑2 meeting with the FDA; zelicapavir has fast‑track status and earlier data showed a 6.7‑day faster recovery and an RSV hospitalization rate of 0% versus 5% for placebo. » More on de.investing.com

Enanta presented progress on its RSV candidates at the Citizens Life Sciences Conference: Zelicapavir is poised for a planned phase‑3 study (600–700 high‑risk adults) after phase‑2 data showing seven days shorter symptom duration and a halved hospitalization rate, while EDP‑323 eliminated viral load within 12 hours in human‑challenge studies. In immunology & inflammation, Enanta is developing three programs (KIT/EDP‑978, STAT6/EPS‑3903, MRGPRX2) with upcoming phase‑1/IND milestones. The company reports $242 million in cash, funding it through 2029, and is exploring partnerships to finance and commercialize its programs. » More on de.investing.com

Enanta announces plans to consult with the FDA on the Phase‑3 design for zelicapavir in Q2 2026 and to begin Phase‑3 preparations with high‑risk adult patients in the second half of the year. A new MRGPRX2‑inhibition program targets chronic spontaneous urticaria, with candidate selection expected in H2 2026. For oral KIT inhibitor EDP‑978, Enanta aims to file an IND in Q1 2026 and report Phase‑1 data in Q4; an IND filing for oral STAT6 inhibitor EPS‑3903 is planned for H2 2026. The company reports a strong cash position with a runway into 2029 and will present its outlook on January 14 at the J.P. Morgan Healthcare Conference; an update on the patent litigation against Pfizer is expected in H2 2026. » More on de.investing.com