Dashboard/ALNY/AMVUTTRA/event

PDUFAPDUFA Decision

AMVUTTRA ATTR-CM sNDA PDUFA

ALNY·AMVUTTRA·ATTR Cardiomyopathy·

Phase 3

current best date

DEC 23

2026

EXACT8 months

Takeaway

FDA decision deadline on expanding AMVUTTRA into ATTR cardiomyopathy. Approval would place AMVUTTRA into the same indication as Pfizer’s tafamidis (Vyndaqel/Vyndamax) and BridgeBio’s acoramidis (Attruby).

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.

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

1 term detected in the takeaway

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
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 PDUFA events

1 historical event · base rate, not prediction

Median 1W move

+42.0%

Median 1M move

+27.4%

Positive outcomes

1/ 1

100%

Negative outcomes

0/ 1

Date	Headline	Outcome	1W	1M	6M
Apr 2025	AMVUTTRA — PDUFA — Approved	positive	+42.0%	+27.4%	+28.7%

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

Disclosure trail

1 observation · sorted by confidence

May 4, 2026·-5485m agopinned · highest confidence
HIGH conf10-Q
top claim
DEC 232026
EXACT
“On April 18, 2026, the FDA granted Priority Review for the supplemental NDA for AMVUTTRA in ATTR-CM. The PDUFA action date is December 23, 2026.”
contextForm 10-Q, MD&A — Recent Developments.
conf 96%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.