Nilopki (XS003, nilotinib)
FDA PDUFA Target Action Date · Xspray Pharma AB
Note: EXPLICIT company-stated CRL — not inferred from absence of approval. FDA acted TWO WEEKS EARLY: the CRL was issued 2026-06-04, ahead of the 2026-06-18 PDUFA date, which is why an approval-window scan found nothing. Company announced it 2026-06-05 at 00:56 CEST (= evening of Jun 4 US time); the company's own 2026-06-26 regulatory update states "The FDA issued a CRL on June 4, 2026," so outcomeDateISO is set to 2026-06-04. FDA acted 2026-06-04 (target was 2026-06-18). Source: https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-receives-crl-from-u-s-fda-for-nilopki/
Drug Information
- Drug Name
- Nilopki (XS003, nilotinib) (CT.gov)
- Application Type
- NDA
- Indication
- chronic myeloid leukemia (CML)
- Approved As
- Nilopki (XS003, nilotinib)
Filing Details
- Company
- Xspray Pharma AB
- Stock Ticker
- XSPRAY
- SEC CIK
- Source
- Company IR →
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
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-05-22. Report an issue