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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

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

Updated label reflects TRUST-I TKI-naïve median duration of response of nearly 50 months No changes to the safety sections of labeling with longer follow-up and no new safety signals identified Approval comes four months ahead of PDUFA date NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib), a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

Sep 17, 2026 03:30 AM • prnewswire.com
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 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

Long-term pooled data from the pivotal TRUST-I and TRUST-II studies showed similar efficacy, including duration of response and progression-free survival, between CD74 and non-CD74 ROS1 fusion-partner subgroups Among patients who received IBTROZI after prior chemotherapy, response rates remained consistent, offering reassurance for patients who begin chemotherapy before a ROS1 fusion is identified NEW YORK, Sept. 15, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced new subgroup analyses from the pivotal TRUST-I and TRUST-II studies evaluating IBTROZI® (taletrectinib) in both TKI- naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

Sep 15, 2026 04:00 AM • prnewswire.com
Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma

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

Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant medical needs for patients with IDH1-mutant glioma Pivotal Phase 3 SIGMA study enrollment underway NEW YORK, Aug. 20, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1. "People with IDH1-mutant glioma urgently need additional treatment options.

Aug 20, 2026 04:00 AM • prnewswire.com
Critical Analysis: Pathfinder Cell Therapy (OTCMKTS:PFND) and Nuvation Bio (NYSE:NUVB)

Critical Analysis: Pathfinder Cell Therapy (OTCMKTS:PFND) and Nuvation Bio (NYSE:NUVB)

Nuvation Bio (NYSE: NUVB - Get Free Report) and Pathfinder Cell Therapy (OTCMKTS:PFND - Get Free Report) are both healthcare companies, but which is the superior stock? We will contrast the two companies based on the strength of their institutional ownership, profitability, analyst recommendations, risk, dividends, earnings and valuation. Insider and Institutional Ownership 61.7% of Nuvation

Aug 15, 2026 11:46 PM • defenseworld.net
Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

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

Achieved $31.7 million in second quarter 2026 total revenue, including $23.2 million in net product revenue for IBTROZI ® (taletrectinib) IBTROZI is the most prescribed ROS1 TKI in in both first-line and overall new patient starts in 2026 based on IQVIA claims from first five months of the year ~85% of the approximately 160 new patients were TKI-naïve, representing QoQ growth of ~30% in this setting Announced positive updated long-term Phase 2 data for safusidenib and significant expansion of clinical program to address broad spectrum of IDH1-mutant glioma Robust balance sheet with cash, cash equivalents, and marketable securities of $661.0 million as of June 30, 2026; additional $36.5 million in net proceeds secured in July 2026 from exercise of the convertible senior notes overallotment option Company to host a conference call today at 8:00 am ET NEW YORK, Aug. 6, 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 second quarter ended June 30, 2026, and provided a business update. "IBTROZI is now the most prescribed ROS1 TKI in both first-line and overall new patient starts in 2026, based on IQVIA claims data from the first five months of the year, reflecting the medical community's growing conviction that IBTROZI's durability profile belongs at the front of the treatment sequence.

Aug 06, 2026 03:30 AM • prnewswire.com
Nuvation Bio to Present New Subgroup Analyses of Pivotal Data for IBTROZI® (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses

Nuvation Bio to Present New Subgroup Analyses of Pivotal Data for IBTROZI® (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses

Analyses of long-term TRUST-I and TRUST-II data will examine consistency of efficacy across key patient subgroups NEW YORK, Aug. 4, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new analyses of long-term Phase 2 TRUST-I and TRUST-II data will be presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) taking place September 12–15, 2026, in Seoul, South Korea, and at the European Society of Medical Oncology Congress (ESMO) October 23–27, 2026, in Madrid, Spain. These findings from the pivotal Phase 2 studies will feature the efficacy and safety of IBTROZI® (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) across key patient subgroups.

Aug 04, 2026 04:00 AM • prnewswire.com

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