Nuvalent Outlines FDA Timelines for ROS1, ALK Drugs as $1.4B Cash Fuels Global Launch Plans

Company highlights regulatory milestones, commercialization strategy, and pipeline progress during investor conference.

Published on Feb. 14, 2026

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Nuvalent NASDAQ: NUVL executives provided updates on the company's lead oncology programs, including the FDA's acceptance of the NDA for zidesamtinib in ROS1-positive non-small cell lung cancer (NSCLC) and plans to submit an NDA for NVL-655 in ALK-positive NSCLC in the first half of 2026. The company also discussed its global commercialization strategy, pipeline plans, and strong financial position with over $1.4 billion in cash.

Why it matters

Nuvalent's focus on clinically validated kinase targets and innovative chemistry to address limitations of existing therapies could provide new treatment options for patients with ROS1- and ALK-positive NSCLC. The company's plans to pursue global commercialization and expand its pipeline demonstrate its ambition to become a leading player in the precision oncology space.

The details

Nuvalent's lead programs include zidesamtinib for ROS1-positive NSCLC and NVL-655 for ALK-positive NSCLC. The FDA has accepted the NDA for zidesamtinib in TKI-pretreated ROS1-positive NSCLC, with a PDUFA date of September 18, 2026. Nuvalent is also planning to submit data to support a potential indication expansion in TKI-naïve ROS1 in the second half of the year. For NVL-655 in ALK-positive NSCLC, Nuvalent has completed a pre-NDA meeting with the FDA and is on track to submit an NDA in the first half of 2026. The company is also progressing the phase 3 ALCAZAR study in TKI-naïve ALK patients.

  • The FDA accepted Nuvalent's NDA for zidesamtinib in TKI-pretreated ROS1-positive NSCLC, with a PDUFA date of September 18, 2026.
  • Nuvalent plans to submit data to support a potential indication expansion for zidesamtinib in TKI-naïve ROS1-positive NSCLC in the second half of 2026.
  • Nuvalent completed a pre-NDA meeting with the FDA for NVL-655 in TKI-pretreated ALK-positive NSCLC and is on track to submit an NDA in the first half of 2026.
  • Nuvalent is progressing the phase 3 ALCAZAR study for NVL-655 in TKI-naïve ALK-positive NSCLC.

The players

Jim Porter

Chief Executive Officer of Nuvalent, a company built around deep chemistry and structure-based drug design expertise, with an emphasis on clinically validated kinase targets.

Alex Balcom

Chief Financial Officer of Nuvalent, who outlined guidance and key upcoming catalysts across the company's portfolio.

Nuvalent

A clinical-stage precision oncology company focused on the discovery, development, and commercialization of targeted therapies for patients with genetically defined cancers.

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What they’re saying

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What’s next

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The takeaway

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