\n\u201cWe’re excited to share new data at this year’s ESC Congress that reinforce our leadership in transthyretin-mediated amyloidosis and advance our hypertension program,” said Yvonne Greenstreet, M.D., Chief Executive Officer of Alnylam. “HELIOS-B remains the foundation of our approach to ATTR-CM, and the multiple presentations we’re sharing this week reflect the continued depth of that program alongside the progress we’re making in hypertension.”<\/p>\n
\nThe data being presented at ESC further characterize treatment outcomes with AMVUTTRA across ATTR manifestations, patient populations and treatment settings. Highlights include a Late-Breaking Science presentation of pre-specified analyses from the HELIOS-B Phase 3 study of vutrisiran evaluating treatment outcomes in patients on background stabilizer therapy. Additional HELIOS-B analyses examine healthy aging and functional capacity, safety and treatment outcomes by sex. Amylo’ExTTRa, a large real-world analysis from the French National Health Data System, further characterizes the multisystem burden of ATTR-CM beyond cardiac manifestations.<\/p>\n
\nThe Company will also present new data from its hypertension program, including a subgroup analysis of the KARDIA-3 Phase 2 study evaluating zilebesiran in combination with a diuretic in patients with uncontrolled hypertension. Zilebesiran is an investigational RNAi therapeutic with the potential to provide continuous control of blood pressure with biannual dosing and is being evaluated in the Phase 3 cardiovascular (CV) outcomes trial, ZENITH.<\/p>\n
\nThe ESC abstracts are available here<\/a>. Alnylam may share additional data and information during the Congress through its Investors<\/a> website and\/or its Capella<\/a> site.<\/p>\n ESC Congress Presentation Details<\/b><\/p>\n ATTR Abstracts<\/span><\/p>\n Amylo’ExTTRa: Exploring Extra-Cardiac Manifestations in Patients with ATTR-CM Using a French National Health Data System Vutrisiran is Associated with Preservation of Intrinsic Capacity and Healthy Ageing in Patients with Transthyretin Amyloidosis with Cardiomyopathy: Post Hoc Analysis of HELIOS-B Fewer Adverse Events Reported in ATTR-CM Patients Treated with Vutrisiran Versus Placebo: Post Hoc Safety Analysis from HELIOS-B Effect of Vutrisiran According to Baseline Tafamidis Use in Transthyretin Amyloidosis with Cardiomyopathy Cardiac Presentation and Treatment Response by Sex in Patients with Transthyretin Amyloidosis: Pooled Analysis of Vutrisiran and Patisiran Phase 3 Studies Hypertension Abstract AMVUTTRA\u00ae <\/sup>(vutrisiran) INDICATIONS AND IMPORTANT SAFETY INFORMATION<\/b><\/p>\n Indications \nAvailability across the EU is subject to local reimbursement timelines.<\/p>\n Important Safety Information<\/b><\/p>\n Reduced Serum Vitamin A Levels and Recommended Supplementation Adverse Reactions For additional information about vutrisiran, please see the full <\/b>Summary of Product Characteristics<\/b><\/a>.<\/b><\/p>\n About AMVUTTRA\u00ae <\/sup>(vutrisiran)<\/b><\/p>\n \nAMVUTTRA\u00ae <\/sup>(vutrisiran) demonstrates strength in RNAi-powered transthyretin (TTR) silencing, delivering rapid knockdown of TTR at the source of disease to address the underlying cause of transthyretin amyloidosis (ATTR). In the HELIOS-B Phase 3 study, AMVUTTRA reduced the risk of all-cause mortality and recurrent CV events compared to placebo in the overall and monotherapy populations by 28.2% and 32.8%, respectively, through 36 months. It is the only TTR silencer approved for both the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) and cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in countries globally. AMVUTTRA is administered once quarterly via subcutaneous injection.<\/p>\n About Transthyretin Amyloidosis (ATTR)<\/b><\/p>\n \nTransthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by pathogenic transthyretin (TTR) proteins, which accumulate as amyloid deposits in various parts of the body, including the nerves, heart, and gastrointestinal tract. Patients may present with polyneuropathy, cardiomyopathy, or both manifestations of disease. There are two different forms of ATTR \u2013 hereditary ATTR (hATTR), which is caused by a TTR gene variant, and wild-type ATTR (wtATTR), which occurs without a TTR gene variant. It is estimated that more than 500,000 people worldwide live with ATTR, with ~80% remaining undiagnosed.<\/p>\n About Zilebesiran<\/b><\/p>\n \nZilebesiran is an investigational, subcutaneously administered RNAi therapeutic in development for cardiovascular (CV) risk reduction in hypertensive patients at high risk or with established CVD. Zilebesiran targets angiotensinogen (AGT), the most upstream precursor in the renin-angiotensin-aldosterone system (RAAS), which plays a role in blood pressure (BP) regulation and impacts CV and renal health. Clinical trial results have shown the potential for zilebesiran to provide continuous control of BP with biannual dosing in a broad population of patients with hypertension. Zilebesiran is being evaluated in a Phase 3 CV outcomes trial, ZENITH, which will assess its ability to reduce the risk of CV death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events in patients with hypertension and established or at high risk of CVD, despite the use of at least two or more antihypertensives. The safety and efficacy of zilebesiran have not been established or evaluated by the FDA, EMA, or any other health authority. Zilebesiran is being co-developed and co-commercialized by Alnylam and Roche.<\/p>\n About Cardiovascular Disease and Hypertension<\/b><\/p>\n \nCardiovascular disease (CVD) is a global health crisis and a leading cause of death worldwide, responsible for approximately 20 million deaths annually. Hypertension is the primary cause of and number one modifiable risk factor for CVD. An estimated one in three adults worldwide have hypertension, and despite wide availability of antihypertensives, up to 80% of all patients, and up to one-third of treated patients, do not reach and maintain blood pressure (BP) targets. Even when BP appears well-managed, continuous control of BP may remain suboptimal, leading to variability in BP during the 24-hour period and in the long-term, putting patients at greater risk of cardiovascular events and end organ damage.<\/p>\n About RNAi<\/b><\/p>\n \nRNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as \u201ca major scientific breakthrough that happens once every decade or so,\u201d and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam\u2019s RNAi therapeutic platform, function upstream of today\u2019s medicines by potently silencing messenger RNA (mRNA) \u2013 the genetic precursors \u2013 that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.<\/p>\n About Alnylam Pharmaceuticals<\/b><\/p>\n \nAlnylam (Nasdaq: ALNY) is a leading global biopharmaceutical company and the pioneer of the RNA interference (RNAi) revolution. The Company is focused on developing transformative therapies with the potential to prevent, halt, or reverse disease. For more than two decades, Alnylam has advanced the Nobel-Prize-winning science of RNAi, delivering critical breakthroughs and six approved medicines. Alnylam has medicines available in more than 70 countries and a rapidly expanding and robust pipeline, in addition to consistently being recognized as an exceptional workplace and socially responsible organization. The Company is executing on its Alnylam 2030 <\/i>strategy to accelerate innovation and scale impact to transform human health. Alnylam routinely posts information that may be important to investors in the \u201cInvestors\u201d section of its website at https:\/\/investors.alnylam.com\/<\/a>. Investors and potential investors are encouraged to consult the Alnylam website regularly.<\/p>\n Alnylam Forward-Looking Statements<\/b><\/p>\n \nThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam\u2019s expectations, beliefs, goals, plans or prospects including, without limitation, statements regarding the potential for zilebesiran to provide continuous control of blood pressure with biannual dosing and to be an innovative treatment approach for hypertension; and Alnylam\u2019s ability to execute on its Alnylam 2030 <\/i>strategy to accelerate innovation and scale impact to transform human health, should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to: Alnylam\u2019s ability to successfully execute on its \u201cAlnylam 2030<\/i>\u201d strategy; Alnylam\u2019s ability to successfully launch, market and sell Alnylam\u2019s approved products globally; Alnylam\u2019s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam\u2019s product candidates; actions or advice of regulatory agencies and Alnylam\u2019s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; delays, interruptions or failures in the manufacture and supply of Alnylam\u2019s marketed products or its product candidates; obtaining, maintaining and protecting intellectual property; Alnylam\u2019s ability to manage its growth and operating expenses through disciplined investment in operations; Alnylam\u2019s ability to maintain strategic business collaborations; Alnylam\u2019s dependence on third parties for the development and commercialization of certain products; the outcome of litigation and government investigations; the risk of future litigation and government investigations; and unexpected expenditures; as well as those risks and uncertainties more fully discussed in the \u201cRisk Factors\u201d filed with Alnylam\u2019s 2025 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam\u2019s subsequent Quarterly Reports on Form 10-Q, and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam\u2019s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260822840046\/en\/<\/a><\/span><\/p>\n Alnylam Pharmaceuticals, Inc. Sarah D\u2019Souza Josh Brodsky KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Health Clinical Trials Research Science Pharmaceutical Cardiology Biotechnology<\/p>\n
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<\/b>Abstract Session: Aetiology, Comorbidities, and Outcomes in Heart Failure
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<\/i>Time: Friday, August 28, 2026, 1:27 \u2013 1:39 pm (CEST), 7:27 \u2013 7:39 am (EDT)
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Presenting Author: Thibaud Damy, France
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Room: Science Box 3 \u2013 Research Gateway Hall A1<\/p>\n
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<\/b>Abstract Session: Approaching Heart Failure Therapy From all Angles
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<\/i>Time: Sunday, August 30, 2026, 8:15 \u2013 8:25 am (CEST), 2:15 \u2013 2:25 am (EDT)
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Presenting Author: Olivier Lairez, France
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Room: Science Box 3 \u2013 Research Gateway Hall A1<\/p>\n
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<\/b>Moderated Poster<\/i>: Heart Failure Redefined: Hypertrophic Cardiomyopathy and Transthyretin Amyloid Cardiomyopathy Precision Treatments
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<\/i>Time: Sunday, August 30, 2026, 9:15 \u2013 9:21 am (CEST), 3:15 \u2013 3:21 am (EDT)
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Presenting Author: St\u00e9phanie Schwarting, Germany
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Room: Station 5 \u2013 Research Gateway Hall A1<\/p>\n
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<\/b>Late-Breaking Clinical Science: Cardiac Amyloidosis
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<\/i>Time: Sunday, August 30, 2026, 2:15 \u2013 2:30 pm (CEST), 8:15 \u2013 8:30 am (EDT)
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Presenting Author: Yasuhiro Hamatani, U.S.
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Room: Ashgabat (Hall A3)<\/p>\n
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<\/b>Abstract Session: Improving Care in Cardiac Amyloidosis
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<\/i>Time: Monday, August 31, 2026, 10:00 \u2013 10:10 am (CEST), 4:00 \u2013 4:10 am (EDT)
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Presenting Author: Amira Zaroui, France
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Room: Science Box 3 \u2013 Research Gateway Hall A1<\/p>\n
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<\/span>Zilebesiran in Combination with a Diuretic in Patients with Uncontrolled Hypertension: A Subgroup Analysis from the Phase 2 KARDIA-3 Trial
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<\/b>Abstract Session<\/i>: <\/b>Treatment of Hypertension
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<\/i>Time: Sunday, August 30, 2026, 8:15 \u2013 8:25 am (CEST), 2:15 \u2013 2:25 am (EDT)
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Presenting Author: Neha Pagidipati, U.S.
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Room: Science Box 4 \u2013 Research Gateway Hall A1<\/p>\n
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<\/b>In the EU, AMVUTTRA\u00ae <\/sup>(vutrisiran) is indicated for the treatment of:<\/p>\n\n
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<\/b>Vutrisiran treatment can lower serum vitamin A levels, therefore supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients.<\/p>\n
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<\/b>Commonly reported adverse reactions with vutrisiran were injection site reactions and increase in blood alkaline phosphatase and alanine transaminase.<\/p>\n<\/p>\n
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(Media)
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Media@alnylam.com
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(Investors)
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Investors@alnylam.com<\/a><\/p>\n
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