zipalertinib — Topline data
Late 2026
Taiho expects to obtain top-line results by the end of 2026.Source filing
CGEM biotech catalysts & pipeline
CULLINAN THERAPEUTICS INC · Data as of 2026-10-25
Upcoming catalysts
zipalertinib — NDA/BLA submission
Late 2026
After agreement with the U.S. FDA, Real-Time Oncology Review program submission process initiated; completion of NDA submission expected by year-end 2026Source filing
CLN-978 — Initial data
Q4 2026
In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.Source filing
velinotamig — Interim data
Q4 2026
Additional multi-dose regimen data in patients with SLE from the Genrix Bio clinical trial in China expected to be shared in Q4 2026Source filing
CLN-049 — Clinical data readout
December
Updated data from the dose escalation portion of the Phase 1 study in DecemberSource filing
CLN-978 — Clinical data readout
December
CLN-978 (CD19 TCE) multi-dose regimen data in SLE, RA and Sjögren's disease in DecemberSource filing
zipalertinib — PDUFA
Feb 27
An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.Source filing
velinotamig — Conference presentation
Nov 8
Multi-dose regimen data from the ongoing Genrix Bio Phase 1 dose escalation study in SLE to be shared in poster session at ACR Convergence 2026 on November 8, 2026, 10:30 a.m. to 12:30 p.m. ETSource filing