ENTA News & Events

Enanta Pharmaceuticals is advancing zelicapavir into a registrational Phase 2b/3 clinical trial in adults at high risk of severe outcomes from RSV infection after a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration. The Phase 2b portion of the trial will confirm the treatment effect with topline data expected in 2027. Enanta also announced plans to initiate a Phase 2b clinical trial of zelicapavir in pediatric patients with RSV, with topline data expected in 2027.

Reports Q2 revenue $17.2M, consensus $17.09M. "Since the inception of our immunology portfolio targeting type 2 diseases, our team has worked diligently to advance highly selective inhibitors of KIT, STAT6 and MRGPRX2 designed to enable convenient oral dosing and best-in-class profiles," said Jay Luly, Ph.D., President and Chief Executive Officer of Enanta. "This quarter, we achieved a key milestone with dosing initiation in our Phase 1 trial of EDP-978, an oral KIT inhibitor in development for chronic urticaria. Along with advancing EDP-978 into the clinic, we remain on track to file an IND for EPS-3903, our oral STAT6 inhibitor, and to nominate an MRGPRX2 development candidate, in the second half of 2026. In parallel, we are continuing to conduct enabling activities for a pivotal study of zelicapavir in adults at high risk of serious complications from RSV infection and look forward to providing an update on the development path later this quarter. With a strong balance sheet and ongoing royalty revenues, we are well-positioned to execute on our strategy and to deliver multiple value-driving milestones over the coming year."

Enanta Pharmaceuticals announced that the first participant has been dosed in a Phase 1 clinical trial of EDP-978, an oral, once-daily KIT inhibitor in development for urticaria and other mast cell-driven diseases. The Phase 1 single-ascending dose, SAD, and multiple-ascending dose, MAD, clinical trial will evaluate the safety, tolerability, pharmacokinetics, PK, and pharmacodynamics, PD, of EDP-978 in healthy adult volunteers.