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pdufa.bio

Olezarsen

Updated ยทnext FDA decision on the calendar

Olezarsen is a Ionis Pharmaceuticals Inc. program in Hypertriglyceridemia. Its next catalyst is a Readout in Mar 2027. 1 FDA decision on record below. Every date links its source.

IONS catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Olezarsen is marketed as TRYNGOLZA (olezarsen); the events below include those tracked under the brand name. Indication under review: Hypertriglyceridemia. Sponsor: Ionis Pharmaceuticals Inc. (IONS). Review status: Ionis states the FDA accepted the sNDA for olezarsen in severe hypertriglyceridemia under Priority Review with a PDUFA target action date of June 30, 2026. Market-cap tier at the time we tracked it: Large. We track 4 catalyst events for this program: 2 upcoming and 2 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 · Jun 24, 2026 ✓ ApprovedIONSPDUFA · Jun 30, 2026IONSReadout · Mar 2027IONSReadout · Jun 2027IONS

Questions

When is Olezarsen's next FDA decision or readout?

The next tracked catalyst for Olezarsen is a Readout in Mar 2027.

What happened at Olezarsen's most recent FDA decision?

On Jun 24, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Olezarsen used for?

In our records Olezarsen is under review or in development for Hypertriglyceridemia.

Who makes Olezarsen?

Ionis Pharmaceuticals Inc. (IONS).

Has Olezarsen been approved by the FDA?

Yes. The FDA approved an application for Olezarsen on Jun 24, 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.