Nuvalent (NUVL) 44th Annual J.P. Morgan Healthcare Conference summary

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.