FDA approves Nuvation Bio’s Ibtrozi for ROS1-positive NSCLC

12 June 2025

The US Food and Drug Administration (FDA) yesterday approved Nuvation Bio’s (NYSE: NUVB) Ibtrozi (taletrectinib), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Nuvation Bio also announced the launch of NuvationConnect, a program designed to support patients prescribed Ibtrozi. The program will offer financial assistance, access to resources and personalized support for eligible patients.

Despite the positive developments, Nuvations’ shares closed down 13% at $2.20 on Wednesday. JMP Securities views the post-approval price drop as "an additional buying opportunity" for investors. The firm’s $6 price target is derived from discounted cash flow analysis. The firm’s analysis suggests the stock weakness was likely due to concerns about the side effect profile detailed in the drug’s label.

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