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Earnings

Nuvation Bio Narrows Loss as IBTROZI Sales Grow

Total revenue reached $45.0 million in the third quarter, including $27.5 million of IBTROZI net product sales, as the company posted a $41.9 million net loss.

Nuvation Bio Inc. (NUVB), a global oncology company, reported $45.0 million in total revenue for the third quarter ended September 30, 2026, including $27.5 million in net product revenue for IBTROZI (taletrectinib).

IBTROZI net product sales rose 18% sequentially after 25% sequential growth in the second quarter from $18.5 million in the first quarter. The company said the third-quarter increase reflected continued adoption and durability of treatment.

New patient starts on IBTROZI remained about 160, matching the prior quarter, even as new patient starts across the overall ROS1-positive non-small cell lung cancer tyrosine kinase inhibitor market declined about 15% sequentially, based on IQVIA claims data. Of IBTROZI starts, 65% were TKI-naïve, down from about 85% in the second quarter. The company said IBTROZI was established as the market leader in new patient starts and total active patients for both first-line and all lines of therapy combined.

In September 2026, the U.S. Food and Drug Administration approved a supplemental New Drug Application for IBTROZI, four months ahead of the January 4, 2027, target action date. The updated label reflects a median duration of response of 49.7 months in TKI-naïve patients from the pivotal TRUST-I study, with a median patient follow-up of 51 months. No changes were made to the safety sections of the label.

Collaboration and license agreements revenue was $17.5 million, compared with $5.4 million a year earlier. The company attributed the increase to a $7.6 million rise in product supply revenue, a $5.0 million sales milestone from Innovent, and a $2.4 million increase in royalty revenue, offset by a $2.9 million decrease in research and development service revenue under collaborations with Innovent and Nippon Kayaku. Taletrectinib was included in China’s National Reimbursement Drug List effective January 1, 2026. Royalty revenue from China and Japan collaboration agreements was $2.7 million.

Research and development expenses were $32.7 million, up from $28.8 million a year earlier, primarily from a $3.3 million increase in third-party clinical trial costs and a $0.5 million increase in personnel costs. Selling, general and administrative expenses were $42.6 million, compared with $37.4 million a year earlier, due to higher salaries, sales and marketing, and miscellaneous expense, offset by lower legal fees.

The company reported a net loss of $41.9 million, or $(0.12) a share, versus a net loss of $55.8 million, or $(0.16) a share, in the comparable period in 2025.

Cash, cash equivalents, and marketable securities were $663.4 million as of September 30, 2026, including $36.5 million of net proceeds secured in July 2026 from exercise of the convertible senior notes overallotment option. In July, Nuvation Bio fully exercised the greenshoe on its 0.75% Convertible Senior Notes due 2032, adding $37.5 million of principal for a $287.5 million offering and about $279.1 million of net proceeds.

In August 2026, the FDA granted Fast Track Designation to safusidenib for IDH1-mutant glioma. The company initiated pivotal Phase 3 study G307 outside the U.S., started Phase 2 study G209 in the U.S. for patients who progressed after vorasidenib, and expanded pivotal Phase 3 study SIGMA into the United Kingdom, France, Sweden, Germany, Italy and Spain. Updated Phase 2 J201 data in chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma showed a centrally assessed objective response rate of 51.9% at a median follow-up of 38.8 months; median progression-free survival was not reached, and the 36-month progression-free survival rate was 79.1%.

Nuvation Bio said it continues to explore new preclinical candidates for its drug-drug conjugate platform and aims to provide further updates by year-end 2026.

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