NUVLFDA PDUFA

Potential regulatory action window

Nuvalent | Zidesamtinib | ROS1-positive NSCLC

Catalyst details

Manual FDA catalyst entered from company guidance and regulatory filings.

Phase

Registration

Expected date

2026-11-20

Expected period

Q4 2026

Source type

manual

quarterupcoming
Source URL

Notes

This record is structured for public-source tracking and manual analyst override. The database stores date confidence separately from exact dates so quarter, half-year, and estimated guidance can be handled without inventing precision.

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History of changes

No sample changes for this catalyst.