Nuvation Bio Secures FDA Fast Track For Safusidenib In IDH1- Mutant Glioma

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.

Nuvation Bio (NUVB) shares rose 2.7% after Cantor Fitzgerald initiated coverage with an Overweight rating and $12 price target. Analyst Li Watsek highlighted two therapies, Ibtrozi and safusidenib, with peak sales estimates of $965M and $1.9B respectively, suggesting significant upside. Cantor also noted potential strategic interest in the company.

JPMorgan initiated coverage of Nuvation Bio with an overweight rating and $13 price target, implying 101% upside. The bank cited early commercial execution of cancer drug IBTROZI and potential revenue growth. Shares rose 1% on Tuesday, up 56% over three months.

Nuvation Bio (NUVB) reported Q2 2026 revenue of $31.7M, including $23.2M IBTROZI product revenue and $8.5M collaboration and license revenue. IBTROZI net product revenue grew 25% QoQ to $23.2M, with 160 new patient starts. Net loss was $62.8M. Cash and marketable securities were $661M. The company raised $279.1M via convertible notes and expects a potential $30M Eisai EU milestone in 1H 2027.

Nuvation Bio (NUVB) reported Q2 call highlights for IBTROZI in ROS1-positive lung cancer, citing TRUST-I results in TKI-naive patients with a 90% objective response rate and 50-month median response duration and progression-free survival. The company said first-line ROS1 TKI use rose nearly 20% through May 2026. It also updated safusidenib Phase II J201 (52% ORR, 79% 36-month PFS) and outlined Phase III/G307 and G209 studies. Cash was $661M after a June convertible notes offering.