Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Approved · ActiveModality: small molecule (oral ROS1 inhibitor)
Aliases IBTROZI, AB-106, DOVBLERON (China)
Target ROS1
Partnerships Daiichi Sankyo (in-license): global rights ($8M milestone on US approval). Innovent: China/Taiwan ($12M reg milestones; up to $17M + $105M milestones; mid-teens to low-twenties royalties). Nippon Kayaku: Japan ($40M upfront + $25M reg milestone; low-mid double-digit royalties). Eisai: EU + 40+ territories (€50M upfront ~$58.7M; up to €145M milestones; up to high-teens royalties)
Indications
ROS1-positive NSCLC, locally advanced or metastatic(Approved)
Status note FDA approved June 11, 2025; approved in Japan (MHLW, Sep 2025) and China (NMPA); US launch June 2025. FDA Orphan Drug Designation; Breakthrough Therapy (FDA + NMPA). EMA and UK MAA validated (Mar 2026, Jun 2026). Phase 2 TRUST-I/TRUST-II, confirmatory Phase 3 TRUST-III vs crizotinib (China), global Phase 3 TRUST-IV adjuvant.
safusidenib
Phase 3 · ActiveModality: small molecule (oral, brain-penetrant)
Target mutant IDH1 (mIDH1)
Partnerships Daiichi Sankyo: exclusive global development/commercialization rights (license amended Apr 2026 to include Japan; $3M milestone paid Feb 2026 on SIGMA conversion to pivotal; $0.5M for Japan amendment)
Indications
IDH1-mutant astrocytoma, high-risk features (maintenance)(Phase 3)
Grade 2 IDH1-mutant glioma (ex-US)(Phase 3)
Grade 2/3 IDH1-mutant glioma progressed after vorasidenib (US)(Phase 2)
Status note SIGMA randomized Phase 3 vs placebo converted to pivotal study. July 2026 announcement of two new studies: pivotal Phase 3 in grade 2 IDH1-mutant glioma (ex-US) and Phase 2 in post-vorasidenib US patients.
Per-asset detail extracted from the 10-Q filed 2026-08-06. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
Sponsor-matched active trials from ClinicalTrials.gov (9 as sponsor, 1 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.
Institutional holder positions from 13F filings. Q/Q change is vs the prior quarter's filing; % of portfolio is the fund's own reported portfolio weight.
Get the weekly biotech catalyst rundown. Cash runways, financings, and trial readouts for all 714 stocks.