Friday, September 18, 2026
Approved July 22, 2026
approved Drug Information
- Drug Name
- Jideytro (zidesamtinib) (CT.gov)
- Application Type
- NDA
- FDA Designations
- BreakthroughOrphan Drug
- Indication
- Adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 tyrosine kinase inhibitor
- Approved As
- JIDEYTRO →
Filing Details
- Company
- Nuvalent, Inc. →
- Stock Ticker
- NUVL
- SEC CIK
- 0001861560
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue