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Nuvalent (NUVL) investor relations material
Nuvalent Corporate Presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Corporate Presentation summary30 Oct, 2025
Corporate overview and strategy
Focus on developing targeted therapies for cancer, with parallel lead programs in ROS1+ and ALK+ NSCLC, and a third program for HER2-altered NSCLC in early clinical development.
Cash runway expected into 2028, supporting ongoing and planned clinical trials and research pipeline.
Team of over 200 employees, hybrid operations based in Cambridge, MA, and listed on Nasdaq.
Leadership and advisory team with significant experience in drug discovery, development, and prior FDA approvals.
Vision to disrupt treatment paradigms with best-in-class profiles designed to supplant current standards of care.
Pipeline and clinical development
Zidesamtinib (NVL-520) for ROS1+ NSCLC: NDA submitted for TKI pre-treated population, ongoing Phase 2 for line-agnostic expansion, with Breakthrough Therapy and Orphan Drug Designations.
Neladalkib (NVL-655) for ALK+ NSCLC: Global Phase 2 (registrational intent for TKI pre-treated) and Phase 3 (TKI-naïve) trials ongoing, with Breakthrough Therapy and Orphan Drug Designations.
NVL-330 for HER2-altered NSCLC: Phase 1a/1b trial ongoing, targeting HER2 mutations and amplification with a brain-penetrant, EGFR-sparing profile.
Additional discovery research programs are active, supporting future pipeline growth.
Key clinical data and milestones
Zidesamtinib pivotal data in TKI pre-treated ROS1+ NSCLC: ORR 44% (all comers), 51% (1 prior TKI), with durable responses and CNS activity; favorable safety profile with low discontinuation rates.
Preliminary data in TKI-naïve ROS1+ NSCLC: ORR 89%, IC-ORR 83%, with no CNS progression among responders.
Neladalkib Phase 1 in heavily pre-treated ALK+ NSCLC: ORR 38% (all doses), 38% at RP2D, with durable responses and activity against single and compound ALK resistance mutations.
Neladalkib demonstrated CNS activity, including in patients previously treated with lorlatinib, and a favorable safety profile supporting long-term use.
Enrollment for pivotal Phase 2 and Phase 3 trials in both ROS1+ and ALK+ NSCLC is strong, with regulatory submissions and pivotal data anticipated through 2025-2026.
Zidesamtinib's TRK-sparing safety profile impact?
Neladalkib's efficacy against ALK compound mutations?
Future plans for discovery research programs?
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Next Nuvalent earnings date
Jefferies London Healthcare Conference 202519 Nov, 2025
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Frequently asked questions
Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer patients. The company specializes in the creation of small molecule inhibitors that are designed to target specific kinases with high precision. Its leading product candidates include NVL-520, which targets ROS1-positive non-small cell lung cancer, and NVL-655, aimed at addressing ALK-positive cancers. Both candidates are designed to overcome resistance and minimize adverse events associated with existing treatments. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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