NUVB

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).

Nuvation Bio Inc. (NUVB) Presents at 12th Annual Cantor Fitzgerald Global Healthcare Conference Transcript

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).

The average of price targets set by Wall Street analysts indicates a potential upside of 91.9% in Nuvation Bio (NUVB). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

NEW YORK, Sept. 2, 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 David Hung, M.D.

Nuvation Bio (NUVB) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Nuvation Bio Inc. is downgraded to Hold after a >200% share price run, reflecting cautious optimism amid early Ibtrozi launch dynamics. Ibtrozi, now the leading ROS1 TKI in new patient starts, posted $23.2m Q2 revenues with strong first-line uptake, but overall patient starts declined sequentially. NUVB management projects a $3.8bn Ibtrozi peak revenue opportunity, but current sales and analyst estimates suggest a more modest trajectory near $650m.

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.

The mean of analysts' price targets for Nuvation Bio (NUVB) points to a 105.7% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Nuvation Bio Inc. (NUVB) Q2 2026 Earnings Call Transcript