Nuvalent submits NDA for neladalkib in ALK+ NSCLC; zidesamtinib PDUFA Sept 18, 2026

Nuvalent, Inc.

NDA for neladalkib in TKI pre-treated ALK+ NSCLC submitted; pivotal data at ASCO 2026.
Zidesamtinib NDA under FDA review; PDUFA target action date September 18, 2026.
Plan to submit data in 2H 2026 for zidesamtinib label expansion in TKI-naïve ROS1+ NSCLC.
Cash $1.3B; net loss $109.3M in Q1 2026 (R&D $83.6M, G&A $35.8M).
Leadership promotions: Dr. Benjamin Lane to Chief Technology Operations Officer; Dr. Kirsten Duncan to VP Medical Affairs.

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