Dashboard/ALNY/AMVUTTRA/event

ReadoutTopline Readoutreported

AMVUTTRA HELIOS-B Phase 3 Topline (ATTR-CM)

ALNY·AMVUTTRA·ATTR Cardiomyopathy·

Phase 3

·NCT05201391

reported

FEB 14

2026

EXACT

Takeaway

Reported 2026-02-14: AMVUTTRA met the primary composite endpoint of all-cause mortality + recurrent CV events in ATTR cardiomyopathy with a 28% relative risk reduction (HR 0.72, p=0.012) over 36 months. Underpins the December 23 PDUFA filing.

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

MoATTR-targeting RNAi

AMVUTTRA (vutrisiran) is a quarterly subcutaneous RNAi therapy developed by Alnylam that silences the TTR gene in liver cells, preventing production of the transthyretin protein that misfolds and deposits as amyloid in ATTR amyloidosis. In ATTR polyneuropathy, amyloid damages peripheral nerves; in ATTR cardiomyopathy, deposits in the heart muscle cause progressive heart failure. AMVUTTRA is approved for hereditary ATTR polyneuropathy and demonstrated a 28% relative reduction in a composite cardiovascular outcomes endpoint in Phase 3, supporting a pending cardiomyopathy label expansion with a December 2026 PDUFA.

Indication

Cardio-Renal

ATTR Cardiomyopathy

MeSH · D028227

No primer in glossary yet.

Trial

active

NCT05201391 ↗

HELIOS-B: Phase 3 Vutrisiran in ATTR Cardiomyopathy

Glossary · what this readout is measuring

2 terms detected in the takeaway

HRendpoint
Hazard Ratio
Relative risk of an event (death, progression) in the treated arm vs control. HR < 1 favors treatment; HR of 0.70 means 30% risk reduction.
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

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

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

Prior ALNY reactions to Readout events

2 historical events · base rate, not prediction

Median 1W move

+25.1%

Median 1M move

+30.3%

Positive outcomes

2/ 2

100%

Negative outcomes

0/ 2

Date	Headline	Outcome	1W	1M	6M
Feb 2026	AMVUTTRA HELIOS-B Phase 3 Topline (ATTR-CM)	positive	+33.4%	+35.6%	+27.7%
Dec 2024	AMVUTTRA — Phase 2b Topline Met Primary Endpoint	positive	+16.8%	+24.9%	+43.8%

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

Disclosure trail

1 observation · sorted by confidence

Feb 14, 2026·2mo agopinned · highest confidence
HIGH confPR
top claim
FEB 142026
EXACT
“AMVUTTRA met the primary composite endpoint of all-cause mortality and recurrent cardiovascular events, with a 28% relative risk reduction (HR 0.72; 95% CI 0.56–0.93; p=0.012) in the overall study population over the 36-month double-blind treatment period.”
conf 99%via human

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.