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.

PRNewsWire • Aug 20, 2026

Wall Street Analysts Predict a 105.71% Upside in Nuvation Bio (NUVB): Here's What You Should Know

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.

Zacks Investment Research • Aug 18, 2026

Nuvation Bio Q2 Earnings Call Highlights

Nuvation Bio NYSE: NUVB reported second-quarter total revenue of $31.7 million, including $23.2 million in net U.S. product revenue from IBTROZI, as the company said use of the ROS1-targeted lung cancer therapy continued to shift toward first-line patients.

MarketBeat • Aug 8, 2026

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

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

Seeking Alpha • Aug 6, 2026

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.

PRNewsWire • Aug 6, 2026

Nuvation Bio Inc. (NUVB) Reports Q2 Loss, Beats Revenue Estimates

Nuvation Bio Inc. (NUVB) came out with a quarterly loss of $0.15 per share in line with the Zacks Consensus Estimate. This compares to a loss of $0.17 per share a year ago.

Zacks Investment Research • Aug 6, 2026

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.

PRNewsWire • Aug 4, 2026

4 Biotech Stocks Likely to Outpace Q2 Earnings Estimates

Medical sector earnings are off to a strong start, and four biotech companies are positioned to potentially beat estimates in upcoming quarterly results.

Zacks Investment Research • Aug 3, 2026

Nuvation Bio Inc. (NUVB) Expected to Beat Earnings Estimates: Should You Buy?

Nuvation Bio (NUVB) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Zacks Investment Research • Jul 30, 2026

Wall Street Analysts See a 94.32% Upside in Nuvation Bio (NUVB): Can the Stock Really Move This High?

The consensus price target hints at a 94.3% upside potential for Nuvation Bio (NUVB). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Zacks Investment Research • Jul 29, 2026