Nuvalent Outlines Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2024 Financial Results
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Nuvalent, Inc. (Nasdaq: NUVL) has outlined its pipeline and business progress, with pivotal data expected in 2025 for TKI pre-treated ROS1-positive and ALK-positive NSCLC populations. The first NDA submission is planned for mid-2025, aiming for approval in 2026 for zidesamtinib. Development strategies for TKI-naïve populations are also in place.
February 27, 2025 | 11:45 am
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Nuvalent has announced key milestones, including pivotal data in 2025 and a planned NDA submission for zidesamtinib in mid-2025. The company is also initiating a Phase 3 trial for neladalkib in 2025.
The announcement of pivotal data and NDA submission timelines is positive for Nuvalent, indicating progress in their drug development pipeline. This could lead to increased investor confidence and potential stock price appreciation.
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IMPORTANCE 80
RELEVANCE 100