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Nuvalent
Nuvalent (NUVL) investor relations material
Nuvalent 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary13 Jan, 2026
Strategic vision and approach
Focus on precisely targeted therapies for cancer, leveraging chemistry and structure-based drug design expertise.
Emphasis on validated kinase targets to accelerate discovery and development.
Addressing key challenges: kinase resistance and selectivity to improve durability and tolerability.
Building strong relationships with physicians and patient advocates to inform drug design.
Portfolio includes programs for ROS1, ALK, and HER2-driven non-small cell lung cancer.
Pipeline progress and clinical data
Zidesamtinib (ROS1) and NVL-655 (ALK) have both received FDA Breakthrough Therapy Designation.
NDA for zidesamtinib accepted with a PDUFA date in September; NDA for NVL-655 to be submitted in H1 2026.
Both drugs show high response rates and durability, including in heavily pretreated and CNS-involved patients.
Enrollment in pivotal studies exceeded projections due to strong demand and differentiated profiles.
HER2 program (NVL-330) in early clinical development, designed for selectivity and brain penetration.
Market opportunity and commercial strategy
Durable responses translate to longer therapy duration, expanding the market size for ROS1 and ALK therapies.
ROS1 market could grow to $1.5–2 billion, aligning with ALK market size.
ALK market already exceeds $2 billion, with potential for further growth as outcomes improve.
Building U.S. commercial infrastructure and preparing for global expansion.
Leveraging 15 years of industry experience to optimize launch and market access strategies.
Tactics to expand ROS1/ALK market to target size
How will neladalkib compete in ALK frontline?
What's the long-term vision for HER2 program?
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Next Nuvalent earnings date
Q4 202527 Feb, 2026
Nuvalent
Next Nuvalent earnings date
Q4 202527 Feb, 2026
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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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