Nuvation Bio Inc.

Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer

The FDA approved a supplemental NDA for IBTROZI (taletrectinib), updating the U.S. label with a median duration of response of 49.7 months in TKI-naïve patients with advanced ROS1-positive NSCLC — more than four years of sustained benefit that Nuvation Bio says is the longest median DOR reported for an FDA-approved ROS1 TKI. The update incorporates a 51-month median follow-up and 14 additional months of data from the pivotal TRUST-I and TRUST-II studies, with no changes to safety labeling and no new safety signals; approval came four months ahead of the PDUFA date. IBTROZI has been fully approved in the U.S. since June 2025 and is marketed in Japan by Nippon Kayaku and in China by Innovent Biologics as DOVBLERON, with EU and UK marketing applications under review via partner Eisai. The strengthened label supports earlier use of IBTROZI and sharpens its competitive stance while confirmatory Phase 3 TRUST-III and TRUST-IV studies continue.

•1mo ago

Nuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung Cancer

Nuvation Bio presented new subgroup analyses of IBTROZI (taletrectinib) at the IASLC 2026 World Conference on Lung Cancer, showing consistent efficacy in advanced ROS1+ NSCLC regardless of prior chemotherapy exposure or ROS1 fusion partner. Among TKI-naive patients, objective response rates were roughly 90% in every subgroup, with median durations of response of 48.3 months with prior chemotherapy versus 54.3 months without, and comparable median PFS of 46.1 versus 44.6 months across CD74 and non-CD74 fusion groups. Long-term pooled follow-up from the pivotal TRUST-I and TRUST-II studies showed a manageable safety profile with no new safety signals; the label already carries hepatotoxicity, ILD/pneumonitis, and QTc warnings. The data bolster clinician confidence in NUVB's first FDA-approved product (approved June 2025) and support broad-use positioning, while confirmatory Phase 3 studies (TRUST-III versus crizotinib and TRUST-IV in adjuvant disease) read out later this decade.

•1mo ago

Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma

Nuvation Bio received FDA Fast Track Designation for safusidenib, an oral brain-penetrant IDH1 inhibitor targeting IDH1-mutant glioma. The designation was based on favorable Phase 2 J201 study data showing a confirmed objective response rate of 51.9% and a 36-month progression-free survival rate of 79.1%. Fast Track status facilitates expedited development and review, potentially shortening the timeline for safusidenib to reach patients while the pivotal Phase 3 SIGMA study enrolls approximately 300 patients.

•2mo ago

Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

Nuvation Bio reported Q2 total revenue of $31.7 million, driven by $23.2 million in net product sales for IBTROZI, which grew 25% quarter-over-quarter. The company strengthened its balance sheet with $661.0 million in cash and equivalents as of June 30, plus an additional $36.5 million raised in July, while simultaneously initiating pivotal Phase 3 studies for safusidenib. Operating expenses increased to support commercialization and R&D, resulting in a net loss of $62.8 million, or $0.18 per share, compared to a loss of $59.0 million in the prior year.

•2mo ago

Nuvation Bio Announces Positive Updated Phase 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma

Nuvation Bio reported updated Phase 2 data for safusidenib in IDH1-mutant glioma, showing a 51.9% confirmed objective response rate and a 79.1% progression-free survival rate at 36 months. Supported by these durable efficacy results, the company is expanding the program with a pivotal Phase 3 study (G307) for newly diagnosed patients outside the U.S. and a Phase 2 study (G209) for U.S. patients who progressed on vorasidenib. These new initiatives complement the ongoing Phase 3 SIGMA study, aiming to provide a comprehensive treatment option across the spectrum of IDH1-mutant gliomas.

•3mo ago

NUVB: 8-K · debt financing

Nuvation Bio Inc. completed a registered underwritten public offering of $250.0 million aggregate principal amount of 0.75% Convertible Senior Notes due 2032. The company granted underwriters a 30-day option to purchase up to an additional $37.5 million aggregate principal amount of notes. The notes are unsecured general obligations bearing interest at 0.75% per year, maturing on July 1, 2032. Holders may convert notes at their option if the stock price exceeds 130% of the conversion price, which is set at approximately $7.84 per share, a 35% premium to the last sale price on June 25, 2026. The company estimates net proceeds of approximately $241.2 million, or $277.6 million if the over-allotment option is exercised. Proceeds were used to repay approximately $58.5 million outstanding under its Credit Agreement, pay $14.9 million for capped call transactions, and fund general corporate purposes. In connection with the offering, the company entered into capped call transactions to offset potential cash payments and reduce dilution. The company also amended its Revenue Interest Financing Agreement and terminated its existing Credit Agreement with Sagard Holdings Manager LP.

SEC 8-K•3mo ago

Nuvation Bio Announces Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated in the United Kingdom

Nuvation Bio announced that the UK Medicines and Healthcare products Regulatory Agency has validated the Marketing Authorisation Application for taletrectinib, submitted by partner Eisai, for advanced ROS1-positive non-small cell lung cancer. The application utilizes the International Recognition Procedure and is based on data from the pivotal Phase 2 TRUST-I and TRUST-II studies, targeting a UK market with approximately 50,200 new lung cancer cases annually. Taletrectinib is already approved in the U.S., China, and Japan, and a similar MAA is currently under review by the European Medicines Agency.

•3mo ago

Nuvation Bio to Present New Quality-of-Life Data for IBTROZI® (Taletrectinib) in Patients with ROS1-Positive Non-Small Cell Lung Cancer at ASCO 2026 Annual Meeting

Nuvation Bio will present new patient-reported outcomes from the pivotal TRUST-II study at ASCO 2026, showing that 88% of patients experienced improved or stable quality of life. The data highlights rapid relief from symptoms like cough and shortness of breath, alongside preserved cognitive function, differentiating IBTROZI from other ROS1 inhibitors associated with neurological impairment. This supportive data underpins a supplemental New Drug Application (sNDA) accepted by the FDA in May 2026, with a target action date of January 4, 2027, and aligns with the company’s focus on patient-centric outcomes.

•4mo ago

Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer

The FDA accepted Nuvation Bio's supplemental NDA for IBTROZI with a target action date of January 4, 2027. The submission includes updated data showing a median duration of response of 49.7 months and median progression-free survival of 49.6 months in TKI-naïve patients. Management believes these long-term results reinforce IBTROZI as a potential new standard of care in advanced ROS1+ NSCLC.

•5mo ago

Nuvation Bio Reports First Quarter 2026 Financial Results and Provides Business Update

Nuvation Bio reported its first quarterly product revenue of $18.5 million from IBTROZI, exceeding 600 total patients treated since launch, and swung to a net income of $5.4 million driven by partnership payments. The company highlighted updated clinical data showing TKI-naïve patients achieved a median progression-free survival of 46.1 months, alongside the acquisition of Japan rights for safusidenib from Daiichi Sankyo. Balance sheet strength remains robust with $533.7 million in cash and securities, supporting the ongoing Phase 3 SIGMA study and future drug-drug conjugate platform updates.

•5mo ago

Nuvation Bio Announces National Comprehensive Cancer Network® Adds Taletrectinib (IBTROZI®) as Recommended Option to Clinical Practice Guidelines in Oncology for Central Nervous System Cancers

Nuvation Bio announced that taletrectinib (IBTROZI) has been added to the NCCN Clinical Practice Guidelines for CNS Cancers as a systemic therapy option for ROS1+ NSCLC patients with brain metastases. The drug had previously received NCCN recommendation as a Preferred Agent for ROS1+ NSCLC in June 2025 following its FDA approval. Data presented at AACR 2026 showed a 76.5% intracranial overall response rate in TKI-naive patients and 65.6% in TKI-pretreated patients.

•5mo ago