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Dec 31, 2024
Nuvalent Q4 2024 Earnings Report
Pipeline and business progress outlined, key anticipated milestones reiterated, and financial results reported for the fourth quarter and full year 2024.
Key Takeaways
Nuvalent reported its fourth quarter and full year 2024 financial results, highlighting pipeline advancements, the reiteration of key milestones, and the implementation of global Expanded Access Programs for zidesamtinib and neladalkib.
Pivotal data is expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations.
The first NDA submission is planned for mid-year 2025, targeting potential first approval in 2026 for zidesamtinib in the TKI pre-treated ROS1-positive NSCLC population.
Development strategies are in place for TKI-naïve populations, including the planned initiation of the ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC in the first half of 2025.
Global Expanded Access Programs have been implemented for zidesamtinib and neladalkib, aligning with the goal of prioritizing patient access.
Forward Guidance
Nuvalent anticipates a steady cadence of milestones across its pipeline this year, supported by a strong balance sheet and a dedicated team.
Positive Outlook
- Pivotal data expected in 2025 for TKI pre-treated ROS1-positive NSCLC.
- Pivotal data expected in 2025 for TKI pre-treated ALK-positive NSCLC.
- First NDA submission planned for mid-year 2025 for zidesamtinib.
- Potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC.
- ALKAZAR Phase 3 trial initiation planned for H1 2025 for front-line ALK-positive NSCLC.
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