Ionis Pharmaceuticals
PDUFA Confirmed
olezarsen
severe hypertriglyceridemia
Resolved
7days ago
FDA decision · Jun 30, 2026
What's at stake The FDA's approval decision on olezarsen for severe hypertriglyceridemia is due Jun 30, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
“Potential approval and launch of olezarsen as the new standard of care for severe hypertriglyceridemia (sHTG) o Submitted U.S. Supplemental New Drug Application (sNDA), following receipt of Breakthrough Therapy Designation”

Provenance

2 sources on file.

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