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Nuvalent (NUVL) investor relations material
Nuvalent UBS Virtual Oncology Day summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.UBS Virtual Oncology Day summary1 Oct, 2025
Company overview and strategy
Focuses on structure-based drug design to develop targeted therapies for cancer, leveraging deep chemistry expertise and physician partnerships.
Prioritizes validated biological targets to accelerate discovery and development, running focused studies to assess efficacy.
Portfolio includes multiple compounds, with two lead programs having breakthrough designation and recent NDA submission.
Zetacentenib program updates
Completed first NDA submission for Zetacentenib in ROS1-positive non-small cell lung cancer, marking a major milestone.
FDA interactions remain thorough and collaborative, with no significant changes in regulatory engagement.
NDA submission based on single-arm studies using ORR, DOR, and safety as primary endpoints, aligned with regulatory precedent.
TKI naive cohort data maturing, with high response rates and strong intracranial activity observed.
Only 2% of patients discontinued due to adverse events, indicating favorable tolerability.
Clinical data and safety profile
Zetacentenib demonstrates activity against ROS1 resistance mutations and CNS disease, with a selective safety profile.
93% of patients with prior TKI exposure maintained response at 18 months, suggesting durable efficacy.
Peripheral edema observed is not linked to tract inhibition and is common among kinase inhibitors.
How does zidesamtinib's unique profile affect market adoption?
Neladalkib's differentiation vs. lorlatinib in 2L?
NVL-330's strategy for other HER2 cancers?
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Next Nuvalent earnings date
Q3 202510 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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