KNSA

Kiniksa Pharmaceuticals International, plc

FDA PDUFA Target Action Date

Friday, June 19, 2026

24 days away

Drug Information

Drug Name: ARCALYST →
Application Type: sBLA

Filing Details

Company: Kiniksa Pharmaceuticals International, plc
Stock Ticker: KNSA
SEC CIK: 0001730430
Source: SEC EDGAR (LLM-extracted from primary filing) →

Active Phase 3 Trials

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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: 2026-05-10. Report an issue