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Nuvation Bio

A global oncology company headquartered in New York, with additional operations in the San Francisco Bay Area and Greater Boston, and an Asia presence that includes Shanghai and Beijing. The company develops and commercializes targeted cancer therapies and runs multinational clinical programs.

Founding and History

Nuvation Bio was founded in 2018 by David Hung. The company is publicly traded on the NYSE under ticker NUVB. In June 2025, Nuvation entered the commercial stage with U.S. approval of its first product, and in January 2026 it expanded the ex-U.S. strategy for that product through a new regional licensing arrangement with Eisai.

Therapy Areas and Focus

Nuvation’s pipeline is focused on oncology, with an emphasis on:

Targeted therapies in genomically defined cancers, including lung cancer and IDH1-mutant glioma
Mechanism-driven programs in solid tumors, including epigenetic modulation and drug-conjugate approaches
The company’s development strategy blends internal R&D with in-licensed assets and selective regional partnering.

Technology Platforms and Modalities

Nuvation’s portfolio is primarily small-molecule targeted oncology, with additional investment in a proprietary drug-conjugate approach. Current disclosed modalities include:

Tyrosine kinase inhibition (ROS1)
Targeted metabolic/oncogenic pathway inhibition (mutant IDH1)
Epigenetic modulation (BD2-selective BET inhibition)
Drug-drug conjugates (DDC), described as chimeric small molecules designed to combine tumor targeting with established anti-cancer payload mechanisms

Key Personnel

David Hung serves as Founder, President, and Chief Executive Officer.

Strategic Partnerships

Nuvation’s lead commercial program, taletrectinib, is managed through a combination of in-licensed global rights and regional out-licensing. In January 2026, Nuvation entered an exclusive licensing agreement with Eisai covering development, registration, and commercialization of taletrectinib across Europe and selected countries outside the U.S., China, and Japan. The company’s earlier regional strategy has also included partnerships in China and Japan for taletrectinib market execution.

FAQ Section

Nuvation Bio develops targeted oncology therapies, combining internal discovery and clinical development with business development to acquire differentiated assets. The approach is centered on mechanism-driven small molecules in defined patient populations, alongside a drug-conjugate platform intended to extend the reach of targeted cytotoxic delivery strategies.

Nuvation is focused on cancer, with current disclosed priorities including ROS1-positive non-small cell lung cancer, IDH1-mutant glioma, and additional solid tumor settings addressed through epigenetic and conjugate-based programs.

Ibtrozi (taletrectinib), a ROS1 tyrosine kinase inhibitor, is approved for advanced ROS1-positive non-small cell lung cancer in the U.S., China, and Japan, and is also being studied in earlier-stage ROS1-positive NSCLC (TRUST-IV).
Safusidenib, a mutant IDH1 inhibitor designed for brain penetration, is in Phase II for diffuse IDH1-mutant glioma and is described as preparing to enter a pivotal study in high-grade IDH1-mutant glioma.
NUV-868, a BD2-selective BET inhibitor, has completed Phase I monotherapy and Phase I b combination studies and is under internal evaluation for next steps.
Drug-drug conjugate (DDC) programs are in preclinical evaluation.

In January 2026, Nuvation and Eisai announced an exclusive licensing agreement expanding taletrectinib’s commercial and development footprint across Europe and additional markets outside the U.S., China, and Japan. In January 2026, Nuvation also provided an update on IBTROZI net product revenue performance and outlook ahead of the J.P. Morgan Healthcare Conference.

For taletrectinib, the regulatory approvals in 2025 were based on clinical study packages in ROS1-positive NSCLC. For safusidenib and other pipeline programs, the company’s public positioning has emphasized stage progression (Phase II and planned pivotal entry for safusidenib; Phase I completion and program review for NUV-868) rather than routine release of detailed datasets outside scientific and regulatory contexts.

Near-term milestones include continued commercial execution and lifecycle development for taletrectinib (including earlier-stage studies), initiation and conduct of a pivotal study for safusidenib in high-grade IDH1-mutant glioma, and decision points on the future development path for NUV-868. Progression of DDC candidates through preclinical selection is a separate pipeline build objective.

Nuvation is led by founder-CEO David Hung and is structured as a fully integrated oncology company spanning development through commercialization, with a track record that now includes regulatory approvals and product launch execution alongside advancement of multiple clinical-stage programs.

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