Nuvalent (NUVL) TD Cowen 46th Annual Health Care Conference summary

Key milestones and strategic updates

• Anticipates first potential product approval in 2024, with a PDUFA date of September 18 for zidesamtinib in TKI-pretreated ROS1 non-small cell lung cancer.

• NDA submission for previously treated ALK non-small cell lung cancer planned for the first half of 2024; global registration strategies are being pursued for both lead programs.

• Commercial readiness efforts are underway, leveraging synergies between two near-term launches and building a specialized oncology sales team.

• HER2 program (NVL-330) is progressing in phase I, with plans to disclose another development candidate by year-end.

Clinical development and regulatory strategy

• Zidesamtinib NDA accepted by FDA for ROS1, with plans to submit additional data for TKI-naive patients in the second half of 2024.

• Neladalkib NDA for previously treated ALK patients to be submitted in 1H 2024; phase III ALKAZAR trial for TKI-naive ALK ongoing globally.

• Regulatory strategies for both programs are designed to support global registration, not waiting for randomized trial data.

• Enrollment in pivotal trials has exceeded expectations, with ALKOVE-1 and ARROS-1 among the fastest enrolling oncology studies.

Market opportunity and competitive positioning

• ALK market for previously treated patients estimated at $500–700 million, with potential for growth by improving durability of response.

• ROS1 market currently around $500 million, with potential to expand to $2.5 billion by increasing patient time on therapy.

• Neladalkib and zidesamtinib are positioned as differentiated therapies with strong CNS penetrance and broad mutation coverage, addressing unmet needs and safety limitations of current standards.

• Pricing strategy will benchmark against existing therapies, with further details to be shared closer to launch.