IBTROZI (taletrectinib) — Regulatory decision
2026
The Company anticipates taletrectinib will be listed on China's National Reimbursement Drug List in 2026.Source filing
NUVB biotech catalysts & pipeline
NUVATION BIO INC · Data as of 2026-09-08
Upcoming catalysts
drug-drug conjugate (DDC) platform — Initial data
Late 2026
Nuvation Bio continues to explore new preclinical candidates for this novel modality and aims to provide further updates by year-end 2026.Source filing
safusidenib — Topline data
2027
Data is anticipated to be available in 2027.Source filing
IBTROZI (taletrectinib) — Filing acceptance
Jan 4
In May 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027.Source filing
IBTROZI (taletrectinib) — PDUFA
Jan 4
In May 2026, we announced the FDA had accepted a supplemental New Drug Application with updated data for IBTROZI in both TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC with a target action date of January 4, 2027.Source filing
safusidenib — Topline data
2029
Data is anticipated to be available in 2029.Source filing
IBTROZI (taletrectinib) — Conference presentation
Sep 12–Sep 15
The Company plans to prepare a supplemental New Drug Application (sNDA) to include the updated data in the IBTROZI label and will provide additional data from the August 2025 data cut-off at a medical conference in 2026.Source filing