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IONS FDA decision: Jun 24, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

Olezarsen was approved by the FDA on June 24, 2026 for hypertriglyceridemia.

Ionis Pharmaceuticals Inc., TRYNGOLZA (olezarsen) · Hypertriglyceridemia.

Run-up into the decision (T-120 → T+5)

PDUFA 6/24/26$86.5$69.681/7/26
Daily close, T-120 (1/7/26) through T+5. Run-up high $86.5 on 2/12/26, low $69.68 on 3/27/26 (T-120 to T-1). FDA decision 6/24/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-24
OutcomeApproved
Drug / candidateTRYNGOLZA (olezarsen) - (CORE)
CompanyIonis Pharmaceuticals Inc.
120-day run-up (T-120→T-1)-3.8%

FDA record of the action: the FDA approved on June 24, 2026, per NDA 218614 S-004 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.

Specialist biotech funds holding IONS, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Baker Bros. Advisors2,047,727$162.4 millionfiled August 14, 2026
Perceptive Advisors566,000$44.9 millionfiled 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.

Questions

Was TRYNGOLZA (olezarsen) approved by the FDA?

Yes. The FDA approved the application for TRYNGOLZA (olezarsen) on June 24, 2026, per the FDA's own record. The primary source is linked on this page.

Which company is behind TRYNGOLZA (olezarsen)?

TRYNGOLZA (olezarsen) is an Ionis Pharmaceuticals Inc. (IONS) program. The FDA decision came on June 24, 2026; the FDA's own record of the decision is linked on this page.

How did IONS stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), IONS moved -3.8%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.