Enanta reports fiscal Q3 2026 results, dosing underway in pediatric RSV trial

Enanta Pharmaceuticals said dosing began in LOTUS, a Phase 2b study of zelicapavir in pediatric patients with RSV.¹ The trial will evaluate zelicapavir in children between 28 days and 36 months old who are hospitalized or non-hospitalized, test positive for RSV, and have had symptoms for up to 72 hours.¹ It is being run with the Penta Foundation and the AMS-PHPT Research Unit at Chiang Mai University, with topline data expected in 2027.¹

On the adult side, the company said it remains on track to start RESOLVE, a registrational Phase 2b/3 trial of zelicapavir in high-risk adults with RSV, in the fourth quarter of 2026.¹ That study will enroll adults at high risk of severe RSV disease, including those aged 75 or older and those with COPD or congestive heart failure.¹ The Phase 2b portion is intended to confirm the treatment effect seen in the earlier RSVHR study.¹ Topline Phase 2b data from RESOLVE is expected in 2027.¹

In immunology, Enanta is on track to report topline Phase 1 data for EDP-978, its oral KIT inhibitor, in the fourth quarter of 2026.¹ It is also targeting an IND filing for EPS-3903, its STAT6 inhibitor, in the second half of 2026,¹ and expects to select an MRGPRX2 development candidate in the same period.¹

On litigation, in June the Federal Circuit affirmed a district court ruling that claims of U.S. Patent No. 11,358,953 were invalid in Enanta's suit against Pfizer,¹ and in July Enanta filed a combined petition for panel or en banc rehearing.¹ A related Unified Patent Court hearing against Pfizer is scheduled for September 29, 2026.¹

Financially, Enanta reported cash, cash equivalents and marketable securities totaling $211.5 million at June 30, 2026,¹ which the company said, along with retained royalties, is expected to fund operations into fiscal 2029.¹