Nuvation Bio earnings in focus as drug launch faces first test

Nuvation Bio Inc. (NUVB) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Nuvation Bio Reports Third Quarter 2026 Financial Results and Provides Business Update Achieved $45.0 million in third quarter 2026 total revenue, including $27.5 million in net product revenue for IBTROZI ® (taletrectinib) IBTROZI continues to be the most prescribed

Nuvation Bio (NYSE: NUVB) reported Q3 2026 revenue of $45.0M, with $27.5M from IBTROZI®. IBTROZI, a ROS1 TKI, is the market leader in new patient starts and total active patients. FDA approved a label update for IBTROZI, reflecting a 49.7-month median duration of response. The FDA granted Fast Track Designation to safusidenib for IDH1-mutant glioma. The company had $663.4M in cash as of September 30, 2026.

Nuvation Bio (NYSE: NUVB) will present updated Phase 2 results and ongoing trial overviews for safusidenib, its investigational IDH1 inhibitor, at the 2026 SNO Annual Meeting. The presentation includes additional data from the Phase 2 J201 study, previously announced in July 2026. Safusidenib is being studied for IDH1-mutant glioma, a type of brain cancer with significant unmet medical needs.

Nuvation Bio (NYSE:NUVB) expanded its Phase 3 SIGMA trial of safusidenib to six European countries, adding to existing sites in the U.S., Australia, China, Canada, and Japan. The study evaluates safusidenib as maintenance therapy for IDH1-mutant astrocytoma, with a primary endpoint of progression-free survival. The trial plans to enroll 300 patients, with an exploratory cohort of 40. The FDA granted Fast Track Designation to safusidenib in August 2026.

Nuvation Bio (NUVB) is expanding its Phase 3 SIGMA trial of safusidenib to six European countries, adding to existing sites in the U.S., Australia, China, Canada, and Japan. The expansion follows the drug's Fast Track designation. According to the company, the trial aims to meet enrollment goals and deliver positive progression-free survival results.

Citizens reiterated a Market Outperform rating and $10.00 price target on Nuvation Bio (NYSE:NUVB), citing solid Q3 performance and expectations of a full-year beat. The firm forecasts $29.2M in Q3 2026 Ibtrozi revenue, up 28% QoQ. NUVB stock has fallen 50% YTD despite a 25% drop in the last three months. Analysts highlight the drug's strong clinical data and market potential.