Alnylam Pharmaceuticals, Inc.
ALNYNext catalyst
cemdisiran
Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive
Get an email about ALNY's next catalysts
Track Alnylam Pharmaceuticals (ALNY) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.
Plus 6 more upcoming events in our data (earnings, Phase 2 readout).See the timeline
7 upcoming, 0 past
ALNY Earnings Report
EPS Est: $1.46 | FQ end Sep/2026 | Call: bmo
FDA PDUFA Date cemdisiran (priority)
For Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive. NDA filing. Extracted from SEC filing: EX-99.1
SourceALN-2232 Phase 2 Est. Readout
Estimated primary completion for ALN-2232 trial (NCT07463846) in Obesity. Topline data typically follows completion by weeks to months.
SourceALN-4324 Phase 2 Est. Readout
Estimated primary completion for ALN-4324 trial (NCT07465224) in Type 2 Diabetes Mellitus (T2DM). Topline data typically follows completion by weeks to months.
SourceALN-6400 Phase 2 Est. Readout (HMBeacon)
Estimated primary completion for ALN-6400 trial (NCT07575308) in Von Willebrand Disease (VWD). Topline data typically follows completion by weeks to months.
SourceALN-APP Phase 2 Est. Readout (cAPPricorn-1)
Estimated primary completion for ALN-APP trial (NCT06393712) in Cerebral Amyloid Angiopathy. Topline data typically follows completion by weeks to months.
SourceALN-4324 Phase 2 Est. Readout
Primary completion for ALN-4324 trial (NCT06845202) in Obese or Overweight Healthy Volunteers
SourceHow ALNY's past catalysts played out
Market Overview
Stock performance and key metrics
Alnylam Pharmaceuticals, Inc. is an American biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics for genetically defined diseases. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts. In 2016, Forbes included the company on its "100 Most Innovative Growth Companies" list.
WebsiteAmvuttra
Vutrisiran
hATTR Amyloidosis
patisiran (ALN-TTR02)
TTR-mediated Amyloidosis
Vutrisiran
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Givosiran
Acute Hepatic Porphyria
Patisiran
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Zilebesiran
Hypertension
Revusiran (ALN-TTRSC)
TTR-mediated Amyloidosis
Lumasiran
PH1
Nucresiran
Transthyretin Amyloidosis With Cardiomyopathy
ALN-TTRSC (revusiran) for subcutaneous administration
TTR-mediated Amyloidosis
ALN-RSV01
Respiratory Syncytial Virus Infections
ALN-AGT01
Hypertension
ALN-6400
Hereditary Hemorrhagic Telangiectasia
Revusiran
Transthyretin (TTR)-Mediated Amyloidosis
VIR-2218
Hepatitis B, Chronic
Indapamide
Hypertension
ALN-APP
Alzheimer Disease
ALN-2232
Obesity
ALN-AGT01 RVR
Hypertension
Mivelsiran
Down Syndrome-Associated Alzheimer's Disease (DS-AD)
ALN-CC5
Paroxysmal Nocturnal Hemoglobinuria (PNH)
ALN-TTR02 (patisiran) administered by intravenous (IV) infusion
TTR-mediated Amyloidosis
ALN-4324
Obese or Overweight Healthy Volunteers
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Amvuttra Vutrisiran | Approved | hATTR Amyloidosis | OrphanFast Track | Patent 2036 |
patisiran (ALN-TTR02) | Phase 3 | TTR-mediated Amyloidosis | - | - |
Vutrisiran | Phase 3 | Transthyretin Amyloidosis (ATTR) With Cardiomyopathy | - | - |
Givosiran | Phase 3 | Acute Hepatic Porphyria | - | - |
Patisiran | Phase 3 | Transthyretin Amyloidosis (ATTR) With Cardiomyopathy | - | - |
Zilebesiran | Phase 3 | Hypertension | - | - |
Revusiran (ALN-TTRSC) | Phase 3 | TTR-mediated Amyloidosis | - | - |
Lumasiran | Phase 3 | PH1 | - | - |
Nucresiran | Phase 3 | Transthyretin Amyloidosis With Cardiomyopathy | - | - |
ALN-TTRSC (revusiran) for subcutaneous administration | Phase 2 | TTR-mediated Amyloidosis | - | - |
ALN-RSV01 | Phase 2 | Respiratory Syncytial Virus Infections | - | - |
ALN-AGT01 | Phase 2 | Hypertension | - | - |
ALN-6400 | Phase 2 | Hereditary Hemorrhagic Telangiectasia | - | - |
Revusiran | Phase 2 | Transthyretin (TTR)-Mediated Amyloidosis | - | - |
VIR-2218 | Phase 2 | Hepatitis B, Chronic | - | - |
Indapamide | Phase 2 | Hypertension | - | - |
ALN-APP | Phase 2 | Alzheimer Disease | OrphanFast TrackBreakthrough | - |
ALN-2232 | Phase 2 | Obesity | - | - |
ALN-AGT01 RVR | Phase 2 | Hypertension | - | - |
Mivelsiran | Phase 2 | Down Syndrome-Associated Alzheimer's Disease (DS-AD) | - | - |
ALN-CC5 | Phase 2 | Paroxysmal Nocturnal Hemoglobinuria (PNH) | - | - |
ALN-TTR02 (patisiran) administered by intravenous (IV) infusion | Phase 2 | TTR-mediated Amyloidosis | - | - |
ALN-4324 | Phase 2 | Obese or Overweight Healthy Volunteers | - | - |
Hypertension
1 drug in this indication
Alzheimer Disease
1 drug in this indication
hATTR Amyloidosis
1 drug in this indication
Huntington's disease
1 drug in this indication
Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)
Frequently asked questions
What is in Alnylam Pharmaceuticals, Inc.'s drug pipeline?→
CatalystAlert tracks 23 drug candidates in Alnylam Pharmaceuticals, Inc.'s (ALNY) pipeline across Phase 3, Phase 2, Approved. Its lead program is Amvuttra (Approved). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is Alnylam Pharmaceuticals, Inc.'s next FDA catalyst?→
Alnylam Pharmaceuticals, Inc.'s (ALNY) next tracked catalyst is a PDUFA date expected November 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track ALNY biotech catalysts?→
Add ALNY to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Alnylam Pharmaceuticals, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.