Drugs / IDE034

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed US (FDA) — — 2025-11-04

“In the fourth quarter IDEAYA submitted an IND for IDE034 , a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC” ideayabio.com ↗

Trials 1

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07503808 Feb 2026 → Jul 2027 expected castration-resistant prostate carcinoma, colorectal cancer, endometrial cancer, esophageal squamous cell carcinoma +4 IDEAYA Biosciences Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-01-11 IDEAYA Biosciences Regulatory IDEAYA Biosciences Provides a Business Update and Outlines 2026 Corporate Objectives at the 44th Annual J.P. Morgan Healthcare Conference ideayabio.com ↗
IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026
2025-12-01 IDEAYA Biosciences Regulatory IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types ideayabio.com ↗

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as IDE034 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07503808 ↗