Dashboard/MDGL/REZDIFFRA/event

InterimInterim Analysis

REZDIFFRA MAESTRO-NASH-OUTCOMES Interim

MDGL·REZDIFFRA·MASH (NASH)·

Approved

·NCT05500222

current best date

'26

QTR5 months

Takeaway

Pre-specified interim of the Phase 3 cardiovascular and liver outcomes trial of REZDIFFRA in MASH. REZDIFFRA is currently approved on biopsy endpoints; outcomes data is required for label expansion into cirrhotic patients and for stronger payor coverage.

What’s at stake

market · comparables · base rate · prior moves

Market opportunity

—

company filings

Peer comparables

1 readout

ClinicalTrials.gov

Stage base rate

~100%

BIO Industry Analysis 2023 (2011–2020)

Avg prior-readout move

—

historical price reactions

MoAthyroid hormone receptor-β agonist

REZDIFFRA (resmetirom) is a once-daily oral thyroid hormone receptor-beta (THR-β) agonist developed by Madrigal Pharmaceuticals and the first FDA-approved drug therapy for MASH — a progressive liver disease in which fat accumulation triggers inflammation and fibrosis. By selectively activating THR-β in liver cells, resmetirom increases fatty acid oxidation and reduces liver fat without the cardiovascular side effects associated with systemic thyroid hormone activation. Approved in March 2024 on biopsy endpoints in non-cirrhotic patients, Madrigal is now running a cardiovascular and liver outcomes trial to support a cirrhotic label expansion and stronger payer coverage.

Indication

NASH / MASH

MASH (NASH)

MeSH · D065626

No primer in glossary yet.

Trial

active

NCT05500222 ↗

MAESTRO-NASH-OUTCOMES Phase 3

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.

Reference data · comparable readouts

How Appr 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

0/0

0% in record

Primary endpoint hit

across 0 readouts

Drug · sponsorPhase · yearOutcomeKey metricSource

efruxifermin

AKRO · NASH

Ph2 · Sep 2024positiveF2-F3 fibrosis improvement 39%PR

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

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

Drug	Company	Modality	Mechanism	Phase	Next catalyst
efruxifermin	AKRO	biologic	FGF21 analog Fc-fusion		CONFERENCE · May 26

Prior MDGL reactions to Interim events

1 historical event · base rate, not prediction

Median 1W move

+11.8%

Median 1M move

+11.2%

Positive outcomes

1/ 1

100%

Negative outcomes

0/ 1

Date	Headline	Outcome	1W	1M	6M
May 2025	REZDIFFRA — Phase 3 Interim — Stopped for Efficacy	positive	+11.8%	+11.2%	+14.9%

Historical MDGL stock reaction to past Interim catalysts. Past performance is not a forecast — base rates anchor expectations, not outcomes. Positive rate 100%.

Disclosure trail

1 observation · sorted by confidence

Apr 4, 2026·26d agopinned · highest confidence
HIGH confPR
top claim
Q4'26
QTR
“The pre-specified interim analysis for the MAESTRO-NASH-OUTCOMES Phase 3 trial of REZDIFFRA is expected in the fourth quarter of 2026.”
conf 86%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.