Nuvation Bio enrolls first patient in phase 3 lung cancer trial

NEW YORK - Nuvation Bio Inc. (NYSE:NUVB), a $1.1 billion market cap biotech company with a strong financial health score according to InvestingPro, has enrolled the first patient in its Phase 3 TRUST-IV study evaluating taletrectinib (IBTROZI) as an adjuvant treatment for patients with resected ROS1-positive early-stage non-small cell lung cancer (NSCLC), the company announced Tuesday. While the company maintains a healthy balance sheet with more cash than debt, analysts note its rapid cash burn rate as it advances its clinical programs.

The trial follows the recent FDA approval of IBTROZI on June 11 for treating locally advanced or metastatic ROS1-positive NSCLC. The study aims to assess whether the targeted therapy can prevent disease recurrence after surgery in early-stage patients. The company’s stock has shown strong momentum, with an impressive 83% return over the past six months, reflecting investor optimism about its pipeline potential. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro.

TRUST-IV will enroll approximately 180 patients across the U.S., Canada, Europe, Japan, and China with ROS1-positive stage IB, II, or IIIA NSCLC who have undergone surgical resection. Participants will be randomized in a 2:1 ratio to receive either taletrectinib or placebo daily, with disease-free survival as the primary endpoint.

"Patients with ROS1 fusion-positive cancers need new options in the adjuvant setting beyond chemotherapy," said Alexander Drilon, M.D., Chief of Early Drug Development at Memorial Sloan Kettering Cancer Center and trial investigator, according to the press release.

ROS1 gene fusions occur in approximately 2% of NSCLC cases, with about 20-30% of newly diagnosed ROS1-positive patients having early-stage disease suitable for surgical resection.

The Phase 3 study is expected to reach primary completion in 2033. IBTROZI is an oral, CNS-active ROS1 inhibitor that received Priority Review and Breakthrough Therapy Designations from the FDA for both first and second-line treatment of advanced disease.

Nuvation Bio, founded in 2018 by former Medivation founder David Hung, M.D., is developing a pipeline of oncology treatments including taletrectinib, safusidenib, NUV-1511, and NUV-868.

The information in this article is based on a press release statement from Nuvation Bio. With analyst price targets ranging from $6 to $10 per share and a current ratio of 9.39x indicating strong liquidity, the company appears well-positioned to fund its clinical development programs. InvestingPro subscribers can access 8 additional key insights and real-time financial metrics to better evaluate the company’s investment potential.

In other recent news, Nuvation Bio Inc. reported its second-quarter earnings for 2025, revealing an earnings per share (EPS) of -$0.17, which aligned with analyst expectations. However, the company significantly exceeded revenue forecasts, reporting $4.8 million compared to the anticipated $416,670. In regulatory developments, Japan’s Ministry of Health, Labour and Welfare has approved Nuvation’s cancer drug IBTROZI for treating ROS1-positive unresectable, advanced, and/or recurrent non-small cell lung cancer, with commercialization in Japan handled by Nippon Kayaku under a 2023 exclusive license agreement. Nuvation Bio is set to receive royalties and a $25 million milestone payment next quarter upon reimbursement price establishment. Analyst firm Jefferies has initiated coverage on Nuvation Bio with a Buy rating and a $10 price target, emphasizing the potential revenue from Nuvation’s lead asset, Ibtrozi. H.C. Wainwright also reiterated its Buy rating and $10 price target, highlighting a new Phase 3 trial for IBTROZI as an adjuvant therapy in certain lung cancer patients. These developments indicate potential growth avenues for Nuvation Bio through both regulatory approvals and analyst confidence.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.