neladalkib PDUFA date: FDA decision expected November 27, 2026
The FDA is expected to decide on neladalkib from Royalty Pharma plc in non-small cell lung cancer (ALK-positive) by the PDUFA target action date of November 27, 2026. For non-small cell lung cancer (ALK-positive). NDA filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 26, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for neladalkib?
- The FDA's PDUFA target action date for neladalkib is November 27, 2026. The FDA can act before that date, and the review can be extended.
- What is neladalkib being reviewed for?
- The application under FDA review covers non-small cell lung cancer (ALK-positive).
- Which company is developing neladalkib?
- Royalty Pharma plc (RPRX).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).