EDP-978 / Enanta Pharma - LARVOL DELTA

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2026 (Businesswire) - "(i) On Track to Report Topline Data from a Phase 1 Trial of EDP-978, an Oral, Once-Daily KIT Inhibitor in Development for the Treatment of Urticaria, in 4Q 2026; (ii) On Track to File an IND for EPS-3903, an Oral, Once-Daily STAT6 Inhibitor and (iii) to Select an MRGPRX2 Development Candidate, in 2H 2026."

IND • P1 data • Pipeline update • Chronic Spontaneous Urticaria • Immunology

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

First-in-human • New P1 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Enanta Pharmaceuticals Announces First Participant Dosed in Phase 1 Clinical Trial of EDP-978, an Oral, Once-Daily KIT Inhibitor, in Development for the Treatment of Urticaria (Businesswire) - "The randomized, double-blind, placebo-controlled, first-in-human Phase 1 clinical trial is expected to enroll approximately 98 healthy adult volunteers ranging in age from 18 to 65 years old to evaluate the safety, tolerability, PK, and PD (including serum tryptase) of EDP-978."

First-in-human • Trial status • Urticaria

Discovery of a Potent and Selective KIT inhibitor for Treatment of Mast Cell-Mediated Diseases (AAAAI 2026) - "Conclusions A potent, selective wild-type KIT inhibitor, EDP-978, was discovered which inhibits mast cell degranulation in vitro and in vivo, and depletes mast cells in vivo. EDP-978 may have therapeutic potential for treating mast cell-mediated diseases."

Immunology • Inflammation • CSF1R • FLT3 • PDGFRA • PDGFRB

EDP-978, a Potent KIT Inhibitor, Demonstrated Dose-dependent Target-Engagement and a Favorable Pharmacokinetic Profile with Once-Daily Dosing Potential in Humans (AAAAI 2026) - "EDP-978 is projected to be a once-daily oral drug with a long half-life of 20 hours in humans. Conclusions The highly favorable pharmacokinetic/pharmacodynamic profile of EDP-978 suggests its potential to be the best-in-class oral therapeutic for the treatment of mast cell-related diseases, including CSU and asthma."

PK/PD data • Asthma • Chronic Spontaneous Urticaria • Dermatology • Immunology • Respiratory Diseases • Urticaria

Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2025 (Yahoo Finance) - "Introduced New Immunology Program Focused on MRGPRX2 Inhibition; On Track to Select a Development Candidate in 2H 2026;On Track to File an Investigational New Drug Application (IND) in 1Q 2026 and Report Phase 1 Data in 4Q 2026 for EDP-978, an Oral, Once-Daily KIT Inhibitor Clinical Candidate; On Track to File an IND in 2H 2026 for EPS-3903, an Oral, Once-Daily STAT6 Inhibitor Development Candidate; Strong Financial Position of $241.9 Million Supported by Continuing Retained Royalties, with Cash Runway Expected to Fund Operations into Fiscal 2029"

Commercial • IND • Pipeline update • Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria

Enanta selected EDP-978, a novel, potent and selective oral KIT inhibitor, as its clinical candidate for the treatment of chronic spontaneous urticaria and potentially other mast cell driven diseases (Businesswire) - "EDP-978 demonstrated nanomolar potency in both binding and cellular assays, had sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. EDP-978 also demonstrated good in vitro and in vivo ADME properties preclinically. The Company is on track to submit an IND in the first quarter of 2026."

IND • Pipeline update • Preclinical • Chronic Spontaneous Urticaria