Nuvalent (NUVL) Q4 2025 earnings summary

Executive summary

• Commercial preparations underway for potential U.S. launch of zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC, pending FDA review with a PDUFA date of September 18, 2026.

• NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC planned for H1 2026; label expansion for zidesamtinib in TKI-naïve ROS1-positive NSCLC planned for H2 2026.

• Strong financial position with cash runway anticipated into 2029.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $1.4 billion as of December 31, 2025.

• R&D expenses were $67.8 million for Q4 2025 and $307.0 million for the full year 2025.

• G&A expenses were $34.4 million for Q4 2025 and $107.3 million for the full year 2025.

• Net loss was $118.7 million for Q4 2025 and $425.4 million for the full year 2025.

• Net loss per share was $1.58 for Q4 2025 and $5.85 for the full year 2025.

Outlook and guidance

• Anticipates U.S. commercial launch of zidesamtinib in 2026, pending FDA approval.

• NDA submission for neladalkib in ALK-positive NSCLC expected in H1 2026; label expansion for zidesamtinib in H2 2026.

• Ongoing enrollment in ALKAZAR Phase 3 trial for TKI-naïve ALK-positive NSCLC and HEROEX-1 trial for HER2-altered NSCLC, with continued progress expected through 2026.

• Plans to disclose a new development candidate by year-end 2026.