Nuvation Bio announces FDA approval of sNDA for Ibtrozi

Nuvation Bio (NUVB) announced FDA approval for its drug IBTROZI, updating the label to include long-term efficacy data showing a median duration of response of 49.7 months in treatment-naïve ROS1+ NSCLC patients. The approval is based on data from the TRUST-I study, with no changes to the safety profile. NUVB stock closed at $5.78, up 3.07% in pre-market trading.

Nuvation Bio Inc (NUVB) shares rose 5.5% after the FDA approved a label update for IBTROZI, adding 49.7-month median duration of response data. The update reflects longer-term data from the TRUST-I study, with no new safety concerns. IBTROZI is approved for treating ROS1-positive non-small cell lung cancer. The FDA approval came ahead of schedule, and the drug is also approved in Japan and China.

Nuvation Bio (NUVB) shares rose premarket after the FDA approved a label update for its cancer therapy Ibtrozi, including new mid-stage trial data. The update followed a supplemental New Drug Application approval.

Nuvation Bio (NUVB) announced FDA approval of its supplemental New Drug Application for IBTROZI (taletrectinib), updating the label to reflect a median duration of response of 49.7 months in TKI-naïve advanced ROS1-positive NSCLC patients. The approval, four months ahead of schedule, includes no new safety signals. IBTROZI is already approved in the U.S., Japan, and China, with regulatory reviews ongoing in Europe and the UK.

JPMorgan initiated coverage of Nuvation Bio (NUVB) with an Overweight rating and a $13 price target, implying 100% upside. The bank cited strong sales of IBTROZI, a lung cancer drug launched in 2026, and potential from safusidenib, an experimental brain tumor drug. Nuvation reported Q2 2026 revenue of $31.7M, beating estimates, but still operating at a loss. The stock has fallen 18% YTD but gained 8% in the past five days.

Nuvation Bio (NUVB) stock rose 2.8% to $7.02 after the FDA granted Fast Track Designation to safusidenib, its therapy for IDH1-mutant glioma, citing Phase 2 study data. Cantor Fitzgerald initiated coverage with an Overweight rating and $12 price target, projecting peak sales of $965M for IBTROZI and $1.9B for safusidenib. The broader market also showed gains.