Nuvalent completes NDA submission to FDA for zidesamtinib in ROS1-positive NSCLC

Nuvalent, Inc.

Completed NDA submission to FDA for zidesamtinib.
Indication: TKI pre-treated advanced ROS1-positive non-small cell lung cancer.
Submission date: September 22, 2025.

item 8.01

Source: SEC EDGAR

accession 0001193125-25-209934

view filing index on sec.gov

view primary document

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.