Olezarsen is an 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.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: hypertriglyceridemia (approved Jun 24, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Ionis Pharmaceuticals Inc. (IONS). Approval record: 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 3 catalyst events for this program: 2 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 2,047,727 | $162.4 million | filed August 14, 2026 |
| Perceptive Advisors | 566,000 | $44.9 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
The next tracked catalyst for Olezarsen is a Readout in Mar 2027.
On Jun 24, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Olezarsen is FDA-approved for hypertriglyceridemia (approved Jun 24, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Ionis Pharmaceuticals Inc. (IONS).
Yes. The FDA approved an application for Olezarsen on Jun 24, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.