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Plozasiran PALISADE Phase 3 FCS Topline

ARWR·plozasiran·Familial Chylomicronemia··NCT06028386
current best date
Q1
'27
QTR8 months
Takeaway

Phase 3 efficacy readout for Arrowhead’s wholly-owned plozasiran (APOC3 siRNA) in familial chylomicronemia syndrome (FCS). Same indication: Ionis’s olezarsen (PDUFA 2026-12-19). Watch: triglyceride reduction at month 12, acute pancreatitis events.

What’s at stake

market · comparables · base rate · prior moves
Market opportunity
company filings
Peer comparables
1 readout
ClinicalTrials.gov
Stage base rate
~58%
BIO Industry Analysis 2023 (2011–2020)
Avg prior-readout move
historical price reactions
Drug
siRNA
plozasiran
INN
MoAAPOC3-targeting RNAi

Plozasiran is a quarterly subcutaneous RNAi therapy developed by Arrowhead Pharmaceuticals that silences the APOC3 gene in liver cells to dramatically reduce apolipoprotein C-III (ApoC-III) — a protein that inhibits the triglyceride-clearing enzyme lipoprotein lipase. In familial chylomicronemia syndrome (FCS), biallelic LPL mutations make patients genetically unable to clear dietary fat, producing triglyceride levels that can exceed 1,000 mg/dL and recurrent life-threatening pancreatitis attacks; ApoC-III suppression restores the patient's residual triglyceride clearance capacity. Plozasiran is in a Phase 3 pivotal trial (PALISADE) for FCS, competing directly with Ionis's olezarsen in the same indication.

Indication
Cardio-Renal
Familial Chylomicronemia
MeSH · D006949

No primer in glossary yet.

Trial
recruiting
NCT06028386
PALISADE Phase 3 Plozasiran in FCS
Phase
Ph 3
N
110
Primary completion
Dec 30, 2026
Glossary · what this readout is measuring
2 terms detected in the takeaway
  • siRNAmodality
    Small interfering RNA

    RNA-based drug that silences a target gene by triggering mRNA degradation. Hepatic gene silencing is the dominant use case.

  • 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.

Sector base rates · reference data
historical record · not prediction

of 2 historical Phase 3 readouts in Cardio-Renal: 1 positive, 1 mixed, 0 negative.

Positive
1/ 2
50%
Mixed
1/ 2
50%
Negative
0/ 2
0%
positive rate 50% · primary endpoint hit rate 100%
Reference data · comparable readouts

How Ph3 readouts in Cardio-Renal have landed.

Reference, not prediction. We surface the historical record so you can read it yourself. We never extrapolate to the upcoming event.

Positive
1/2
50% in record
Primary endpoint hit
100%
across 2 readouts
Drug · sponsorPhase · yearOutcomeKey metricSource
omecamtiv mecarbil
CYTK · HF
Ph3 · Oct 2022mixednarrow CV-death/HF benefit; FDA declinedFDA
finerenone (FIDELIO-DKD)
BAYRY · CKD
Ph3 · Jul 2020positive18% reduction in primary compositePR
sorted by phase match, then recency · sources span PR wires, CT.gov, FDA notices, and conference presentations · we never editorialize the outcome label

Competitive landscape

4 peers in Cardio-Renal · ranked by indication + modality match
DrugCompanyModalityMechanismPhaseNext catalyst
olezarsenIONSoligonucleotideApoCIII antisense oligonucleotidePDUFA · Dec 26
AMVUTTRAvutrisiranALNYsiRNATTR-targeting RNAiPDUFA · Dec 26
VERVE-102VERVgene therapyLNP-delivered base editor targeting PCSK9INTERIM · Nov 26
XPHOZAHtenapanorARDXsmall moleculeNHE3 inhibitorCMC · Jul 26

Prior ARWR reactions to Readout events

1 historical event · base rate, not prediction
Median 1W move
-16.7%
Median 1M move
-26.2%
Positive outcomes
0/ 1
0%
Negative outcomes
1/ 1
100%
DateHeadlineOutcome1W1M6M
Sep 2024plozasiran — Phase 3 Topline — Mixed Resultnegative-16.7%-26.2%-42.7%

Historical ARWR stock reaction to past Readout catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 0%.

Disclosure trail

1 observation · sorted by confidence
  1. Apr 21, 2026·9d agopinned · highest confidence
    HIGH confPR
    top claim
    Q1'27
    QTR
    PALISADE, the Phase 3 study of plozasiran in familial chylomicronemia syndrome, is expected to deliver topline data in Q1 2027.
    conf 85%via llm

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.

Disclaimer·BioSight aggregates publicly available data (SEC EDGAR, ClinicalTrials.gov, FDA, company press releases) and is provided as is for informational purposes only. Nothing here is investment, financial, legal, tax, or medical advice, or an offer to buy or sell any security. We make no warranty as to accuracy, completeness, or timeliness; dates and filings may contain errors or be superseded without notice; past events do not predict future outcomes. To the maximum extent permitted by law, BioSight, its operators, contributors, and affiliates disclaim all liability for any loss or damage arising from use of or reliance on this site. You are solely responsible for your own investment decisions — consult a licensed professional before acting on any information.

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