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.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.85

Nuvalent, Inc. reported financial results for first quarter 2026.

Period: first quarter 2026
Result: reported results

Exact text from the filing

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results.

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Nuvalent, Inc. filing history →

Source: SEC EDGAR

accession 0001861560-26-000020

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