Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

Thermo Fisher Scientific, the world leader in serving science, will now manufacture drug product for Nuvation Bio in the United States Move by Nuvation Bio further ensures critical drug supply for patients and providers NEW YORK, May 13, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the successful completion of process tech transfer and product introduction to Thermo Fisher Scientific, the world leader in serving science, for IBTROZI® (taletrectinib) to treat advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The transition was submitted as a supplement to the IBTROZI New Drug Application held by Nuvation Bio and is now complete.

07.05.2026

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Nuvation Bio Inc. (NYSE: NUVB)

NEW YORK, May 7, 2026 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating Nuvation Bio Inc. (NYSE: NUVB) on behalf of the company's shareholders. The investigation seeks to determine whether Nuvation Bio Inc.'s directors breached their fiduciary duties in connection with recent corporate actions.

06.05.2026

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

Application includes updated TRUST-I TKI-naïve median duration of response (mDOR) and median progression-free survival (mPFS) of more than 4 years, as well as TRUST-II TKI-pretreated mDOR of nearly 20 months FDA has assigned a target action date of January 4, 2027 NEW YORK, May 6, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI ® (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) with a target action date of January 4, 2027. The submission, which fulfills an FDA post-marketing commitment and is intended to update the efficacy information provided in the IBTROZI label, includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, further validating the overall clinical profile with long-term follow-up.

04.05.2026

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

Achieved $18.5 million in first quarter of 2026 net product revenues for IBTROZI ® (taletrectinib); majority of the approximately 200 patients started on IBTROZI in the first quarter of 2026 were TKI-naïve, highlighting continued momentum in the first-line setting Presented newly updated clinical data demonstrating IBTROZI's impressive durability of response and progression-free survival in TKI-naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) at AACR 2026 Announced acquisition of Japan rights to safusidenib from Daiichi Sankyo, enabling global development and commercialization of promising investigational medicine Strong balance sheet with cash, cash equivalents, and marketable securities of $533.7 million as of March 31, 2026 Company to host a conference call today at 4:30 pm ET NEW YORK, May 4, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. "We are pleased with IBTROZI's ongoing launch trends in the first quarter of 2026, as we continue to deepen its adoption across lines of therapy and make significant progress in becoming the standard of care for people living with advanced ROS1-positive NSCLC.

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Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Nuvation Bio Inc. (NYSE: NUVB)

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

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

Nuvation Bio: David Hung's Latest Venture Looks Undervalued At Current Level

Nuvation Bio: Buy The Ibtrozi Launch (Rating Upgrade)

Nuvation Bio to Present at the Jefferies Global Healthcare Conference

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 Inc. (NUVB) Presents at RBC Capital Markets Global Healthcare Conference 2026 Transcript

Nuvation Bio Inc. (NUVB) Presents at H.C. Wainwright 4th Annual BioConnect Investor Conference Transcript

Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Nuvation Bio Inc. (NYSE: NUVB)

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

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

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Nuvation Bio Inc. (NUVB)

Aksiya tahlili uchun eng kuchli vositalarga ega bo'ling

Finranks

Kompaniya

Biz bilan bog'lanish

Bizni kuzating

Nuvation Bio Inc. (NUVB)

Nuvation Bio: David Hung's Latest Venture Looks Undervalued At Current Level

Nuvation Bio: Buy The Ibtrozi Launch (Rating Upgrade)

Nuvation Bio to Present at the Jefferies Global Healthcare Conference

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 Inc. (NUVB) Presents at RBC Capital Markets Global Healthcare Conference 2026 Transcript

Nuvation Bio Inc. (NUVB) Presents at H.C. Wainwright 4th Annual BioConnect Investor Conference Transcript

Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Nuvation Bio Inc. (NYSE: NUVB)

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

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

Nuvation Bio: David Hung's Latest Venture Looks Undervalued At Current Level

Nuvation Bio: Buy The Ibtrozi Launch (Rating Upgrade)

Nuvation Bio to Present at the Jefferies Global Healthcare Conference

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 Inc. (NUVB) Presents at RBC Capital Markets Global Healthcare Conference 2026 Transcript

Nuvation Bio Inc. (NUVB) Presents at H.C. Wainwright 4th Annual BioConnect Investor Conference Transcript

Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

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Press-relizlar

Nuvation Bio to Collaborate with Thermo Fisher Scientific for U.S.-Based Manufacturing of IBTROZI® for ROS1-Positive Non-Small Cell Lung Cancer

SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Nuvation Bio Inc. (NYSE: NUVB)

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

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