EDP-978 / Enanta Pharma - LARVOL DELTA

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