Dashboard/IONS/olezarsen/event

PDUFAPDUFA Decision

Olezarsen FCS NDA PDUFA

IONS·olezarsen·Familial Chylomicronemia·

Filed

current best date

DEC 19

2026

EXACT8 months

Takeaway

FDA decision deadline for olezarsen in familial chylomicronemia syndrome (FCS) — an ultra-rare lipid disorder where patients have triglycerides >880 mg/dL and high pancreatitis risk. Olezarsen would be Ionis’s first wholly-owned U.S. commercial product. Same indication: Arrowhead’s plozasiran (Phase 3 readout Q1 2027).

What’s at stake

market · comparables · base rate · prior moves

Market opportunity

—

company filings

Peer comparables

1 readout

ClinicalTrials.gov

Stage base rate

~91%

BIO Industry Analysis 2023 (2011–2020)

Avg prior-readout move

—

historical price reactions

MoAApoCIII antisense oligonucleotide

Olezarsen is a monthly subcutaneous antisense oligonucleotide (ASO) developed by Ionis that suppresses hepatic production of apolipoprotein C-III (ApoC-III) — a protein that inhibits triglyceride clearance enzymes — to treat familial chylomicronemia syndrome (FCS). FCS is an ultra-rare inherited disorder in which genetic inability to clear dietary fat causes triglyceride levels exceeding 2,000 mg/dL and recurrent life-threatening pancreatitis attacks; there is currently only one approved therapy, which has limited uptake due to platelet toxicity. An NDA has been filed with a PDUFA date of December 2026; approval would make olezarsen Ionis's first wholly-owned commercial product in the United States.

Indication

Cardio-Renal

Familial Chylomicronemia

MeSH · D006949

No primer in glossary yet.

Source signal

This event was extracted from a primary disclosure. The full chain of citations is in the disclosure trail below.

Glossary · what this readout is measuring

2 terms detected in the takeaway

NDAregulatory
New Drug Application
FDA submission for approval of a small-molecule drug. Triggers the PDUFA clock.
PDUFAregulatory
Prescription Drug User Fee Act
The FDA's self-imposed review deadline for an NDA/BLA. Standard reviews are ~10 months from filing; priority reviews are ~6 months.

Competitive landscape

4 peers in Cardio-Renal · ranked by indication + modality match

Drug	Company	Modality	Mechanism	Next catalyst
plozasiran	ARWR	siRNA	APOC3-targeting RNAi	CONFERENCE · May 26
AMVUTTRAvutrisiran	ALNY	siRNA	TTR-targeting RNAi	PDUFA · Dec 26
XPHOZAHtenapanor	ARDX	small molecule	NHE3 inhibitor	CMC · Jul 26
VERVE-102	VERV	gene therapy	LNP-delivered base editor targeting PCSK9	INTERIM · Nov 26

Prior IONS reactions to PDUFA events

2 historical events · base rate, not prediction

Median 1W move

+6.7%

Median 1M move

-1.0%

Positive outcomes

1/ 2

50%

Negative outcomes

1/ 2

50%

Date	Headline	Outcome	1W	1M	6M
Mar 2025	olezarsen — PDUFA — Approved	positive	+40.1%	+24.6%	+43.1%
Dec 2024	olezarsen — PDUFA — CRL Issued	negative	-26.7%	-26.7%	-20.3%

Historical IONS stock reaction to past PDUFA catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 50%.

Disclosure trail

1 observation · sorted by confidence

Mar 22, 2026·1mo agopinned · highest confidence
HIGH confFDA
top claim
DEC 192026
EXACT
“PDUFA action date for olezarsen NDA (familial chylomicronemia syndrome): December 19, 2026.”
contextFDA PDUFA Action Date Calendar — public notice.
conf 99%via fda calendar

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.