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WAKIX (pitolisant)

Updated ยทnext FDA decision on the calendar

WAKIX (pitolisant) The FDA approved it on Feb 17, 2026. 1 FDA decision on record below. Every date links its source.

HRMY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Feb 17, 2026 ✓ ApprovedHRMY

Questions

When is WAKIX (pitolisant)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for WAKIX (pitolisant); 1 FDA decision is on record below.

What happened at WAKIX (pitolisant)'s most recent FDA decision?

On Feb 17, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has WAKIX (pitolisant) been approved by the FDA?

Yes. The FDA approved an application for WAKIX (pitolisant) on Feb 17, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

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