GSK PDUFA Date: Neladalkib

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

FDA decision (PDUFA) target Nov 2026 · GSK plc · TKI-pretreated ALK-positive NSCLC

Source: GSK plc 6-K 2026-07-28 (Q2 2026 results). “…an investigational ALK tyrosine kinase inhibitor (TKI) currently under review with the US FDA for use by patients with TKI pre-treated ALK-positive NSCLC, with PDUFA date anticipated in November 2026”

Key facts

FDA PDUFA target dateNov 2026

Drug / candidateNeladalkib (NVL-655)

IndicationTKI-pretreated ALK-positive NSCLC

CompanyGSK plc

Market-cap tierLarge

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FAQ

When is the GSK PDUFA date?

The FDA PDUFA target date for GSK (GSK plc) is expected in November 2026 for Neladalkib (NVL-655). Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is GSK's drug Neladalkib?

Neladalkib (NVL-655) is GSK plc's candidate under FDA review for TKI-pretreated ALK-positive NSCLC.