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InterimInterim Analysis

Efruxifermin SYMMETRY Phase 3 Interim (MASH)

AKRO·efruxifermin·MASH (NASH)··NCT04880421
current best date
Q1
'27
QTR8 months
Takeaway

Pre-specified Phase 3 interim for efruxifermin (FGF21 analog) in compensated cirrhotic MASH. REZDIFFRA (the only approved MASH drug) is not approved in cirrhotic patients. Watch: ≥1-stage fibrosis improvement without MASH worsening at week 36.

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
biologic
efruxifermin
INN
MoAFGF21 analog Fc-fusion

Efruxifermin is a weekly subcutaneous Fc-fusion analog of fibroblast growth factor 21 (FGF21) — a liver-secreted hormone regulating fat metabolism, insulin sensitivity, and energy balance — developed by Akero Therapeutics for MASH. The Fc-fusion domain extends the half-life of FGF21 from minutes to a week, enabling once-weekly dosing. Akero is evaluating efruxifermin in Phase 3 trials in both pre-cirrhotic (F2/F3) and cirrhotic (F4) MASH; REZDIFFRA, the only approved MASH drug, was not studied in cirrhotic patients, leaving that population entirely without an approved option.

Indication
NASH / MASH
MASH (NASH)
MeSH · D065626

No primer in glossary yet.

Trial
active
NCT04880421
SYMMETRY Phase 3 Efruxifermin in pre-cirrhotic MASH
Phase
Ph 3
N
1,650
Primary completion
Feb 28, 2027
Glossary · what this readout is measuring
1 term detected in the takeaway
  • MASHdisease
    Metabolic-Associated Steatohepatitis

    Liver inflammation caused by fat accumulation, with metabolic risk factors. Renamed from NASH in 2023. Resmetirom (REZDIFFRA) is the only approved therapy.

Sector base rates · reference data
historical record · not prediction

of 3 historical Phase 3 readouts in NASH / MASH: 1 positive, 1 mixed, 1 negative.

Positive
1/ 3
33%
Mixed
1/ 3
33%
Negative
1/ 3
33%
positive rate 33% · primary endpoint hit rate 67%
Reference data · comparable readouts

How Ph3 readouts in NASH / MASH have landed.

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

Positive
1/3
33% in record
Primary endpoint hit
67%
across 3 readouts
Drug · sponsorPhase · yearOutcomeKey metricSource
lanifibranor
INVE · NASH
Ph3 · Jul 2024mixedhit primary; long-term durability questioned8-K
aramchol
GLMD · NASH
Ph3 · Apr 2024negativefailed primary; histology unchanged8-K
resmetirom (MAESTRO-NASH)
MDGL · NASH
Ph3 · Dec 2023positiveNASH resolution 26% vs 9% pboPR
efruxifermin
AKRO · NASH
Ph2 · Sep 2024positiveF2-F3 fibrosis improvement 39%PR
pegozafermin
89bio · NASH
Ph2 · Jun 2023positivefibrosis improvement 26%conference
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

1 peer in NASH / MASH · ranked by indication + modality match
DrugCompanyModalityMechanismPhaseNext catalyst
REZDIFFRAresmetiromMDGLsmall moleculethyroid hormone receptor-β agonistINTERIM · Oct 26

Disclosure trail

1 observation · sorted by confidence
  1. Apr 9, 2026·21d agopinned · highest confidence
    MED confPR
    top claim
    Q1'27
    QTR
    The pre-specified Phase 3 SYMMETRY interim analysis is expected in the first quarter of 2027.
    conf 83%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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