Nuvation Bio received FDA approval for Ibtrozi (taletrectinib), a next-generation oral inhibitor targeting ROS1-positive non-small cell lung cancer (NSCLC), a disease subset with limited existing treatments. Ibtrozi showed high response rates, durable benefit, and intracranial activity in clinical trials, offering an alternative to competitors with improved CNS safety profiles. The approval anticipates addressing a niche market with high unmet needs, particularly for patients with brain metastases. Shares of Nuvation Bio reacted to the approval but remain under pressure.