Safusidenib - (J201) - (SIGMA)

November 4, 2026: Nuvation Bio (NYSE: NUVB) reported a business update highlighting recent catalysts for IBTROZI (taletrectinib) and safusidenib.

IBTROZI / taletrectinib (advanced ROS1+ NSCLC): In September 2026, the FDA approved an sNDA for IBTROZI, four months ahead of the January 4, 2027 target action date, updating the label to show median duration of response of 49.7 months in TKI-naïve patients from the pivotal TRUST-I study based on 51 months median follow-up; safety-label sections were unchanged. The company also reported September 2026 subgroup analyses from TRUST-I/TRUST-II at IASLC WCLC showing consistent efficacy across key subgroups, and October 2026 updated TRUST-II efficacy/safety data in previously entrectinib-treated patients at ESMO 2026. Q3 2026 net product revenue was $27.5 million.

Safusidenib (IDH1-mutant glioma): In August 2026, the FDA granted Fast Track Designation. Updated Phase 2 J201 data reported in July 2026 showed centrally assessed ORR of 51.9%, 36-month PFS rate of 79.1%, and median PFS not reached at 38.8 months median follow-up in chemotherapy- and radiotherapy-naïve grade 2 disease, with no new safety signals. Nuvation also initiated Phase 3 G307 and Phase 2 G209, expanded the pivotal Phase 3 SIGMA study into additional European countries, and plans four posters at the Society for Neuro-Oncology meeting on November 12-15, 2026.