Nuvation Bio’s IBTROZI Receives FDA Approval

Nuvation Bio ( (NUVB) ) has issued an announcement.

On June 11, 2025, Nuvation Bio announced that the U.S. FDA approved IBTROZI (taletrectinib) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. The approval is based on significant results from the TRUST-I and TRUST-II studies, showing high response rates and durable outcomes, particularly in TKI-naïve patients. The drug’s ability to penetrate the central nervous system and manage brain metastases effectively positions it as a potentially best-in-class treatment, with manageable side effects and a favorable safety profile.

The most recent analyst rating on (NUVB) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Nuvation Bio stock, see the NUVB Stock Forecast page.

Spark’s Take on NUVB Stock

According to Spark, TipRanks’ AI Analyst, NUVB is a Neutral.

Nuvation Bio’s stock is primarily challenged by weak financial performance, characterized by ongoing losses and negative cash flows, despite a strong equity foundation. While there is short-term momentum in the stock price, the lack of sustainable income and negative valuation metrics, such as a negative P/E ratio, weigh heavily on the overall score. The stock’s speculative nature and reliance on future growth prospects contribute to its moderate overall score.

To see Spark’s full report on NUVB stock, click here.

More about Nuvation Bio

Nuvation Bio is a global, commercial-stage oncology company focused on developing innovative, first- or best-in-class medicines for diseases with large unmet patient needs. The company has a robust pipeline, including IBTROZI, a next-generation ROS1 inhibitor for advanced ROS1+ non-small cell lung cancer, and other promising candidates like safusidenib and NUV-1511.

Average Trading Volume: 3,646,484

Technical Sentiment Signal: Buy

Current Market Cap: $860.9M

For a thorough assessment of NUVB stock, go to TipRanks’ Stock Analysis page.