Nuvalent Announces OnTarget 2026 Operating Plan Progress and Outlines Key Anticipated 2026 Milestones

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• Nuvalent plans to submit data to FDA for potential indication expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC in the second half of 2026

  80% confidence

• Nuvalent anticipates commercial launch in the U.S. of zidesamtinib for treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI in 2026, pending FDA review

  80% confidence

• With cash runway anticipated into 2029, our strong financial position enables us to focus on the execution of a first U.S. launch while also supporting the continued advancement and expansion of both our commercial and development portfolios

  80% confidence

• We have completed a pre-NDA meeting with the FDA for our ALK program and plan to move forward with an NDA submission of the data for TKI pre-treated patients with ALK-positive NSCLC from our ALKOVE-1 study of neladalkib in the first half of this year

  80% confidence

• Nuvalent plans to submit NDA for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC in the first half of 2026

  80% confidence

• Over the past two years, the Nuvalent team has seamlessly executed against our OnTarget 2026 operating plan towards our goal of a first potential FDA approval, ending 2025 with the recent FDA acceptance of our NDA for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and commercial preparedness activities well underway

  80% confidence

• In the second half of the year, we anticipate submitting data to support a potential indication expansion for zidesamtinib in ROS1-positive NSCLC, and growing our discovery portfolio with a new development candidate

  80% confidence

• Nuvalent plans to disclose a new development candidate by year-end 2026

  80% confidence

• If zidesamtinib is approved, a first commercial launch in 2026 would be a transformative moment for Nuvalent and the first step towards realizing our mission of becoming a sustainable company capable of not only discovering and developing, but delivering new medicines for patients with cancer

  80% confidence

• We believe the achievement of these anticipated 2026 milestones would position Nuvalent for continued, long-term growth driven by delivering meaningful impact for patients with NSCLC and beyond

  80% confidence

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