Articles from Alnylam Pharmaceuticals, Inc.
Alnylam to Webcast Conference Call Discussing Fourth Quarter and Full Year 2024 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the fourth quarter and year ending December 31, 2024 on Thursday, February 13, 2025, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 30, 2025
Alnylam Announces Preliminary* Fourth Quarter and Full Year 2024 Global Net Product Revenues and Provides 2025 Combined Net Product Revenue Guidance and Pipeline Goals
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced its preliminary* fourth quarter and full year 2024 global net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO. In addition, the Company provided 2025 net product revenue, non-GAAP operating income profitability, and pipeline goals guidance.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 12, 2025
Alnylam to Webcast Presentation at 43rd Annual J.P. Morgan Healthcare Conference
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview and participate in a Q&A session at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 9:45 am PT (12:45 pm ET) at The Westin St. Francis in San Francisco. As part of the presentation, the Company will discuss unaudited fourth quarter and full year 2024 global net product revenues.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 6, 2025
Alnylam to Webcast Presentation at Piper Sandler 36th Annual Healthcare Conference
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the Piper Sandler 36th Annual Healthcare Conference on Thursday, December 5, 2024 at 11:00 am ET at the Lotte New York Palace Hotel in New York City.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 27, 2024
Alnylam Announces U.S. Food and Drug Administration Acceptance of Supplemental New Drug Application for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental New Drug Application (sNDA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Based on the Company’s use of a Priority Review Voucher, the FDA has set an action date goal of March 23, 2025, under the Prescription Drug User Fee Act (PDUFA). The FDA has informed the Company that it is not planning to hold an advisory committee meeting at this time to review the application.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 25, 2024
Alnylam Announces Interim Phase 1 Data of Nucresiran (ALN-TTRsc04) Showing Rapid Knockdown of TTR that is Sustained at Six Months Following a Single Dose
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the presentation of new results from its Phase 1 study of nucresiran (formerly ALN-TTRsc04), a next-generation RNAi therapeutic in development for the treatment of transthyretin (ATTR) amyloidosis. The data were presented in an oral session at the American Heart Association Scientific Sessions 2024 in Chicago.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 17, 2024
Alnylam to Webcast Presentations at Upcoming November Investor Conferences
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences:
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 4, 2024
Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter ended September 30, 2024 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 31, 2024
Alnylam to Showcase Latest Data from TTR Franchise and Hypertension Program at American Heart Association Scientific Sessions 2024
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Company will present data from its transthyretin amyloidosis (ATTR) and hypertension programs at the upcoming American Heart Association (AHA) Scientific Sessions 2024, November 16–18, 2024.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 30, 2024
Alnylam to Webcast Conference Call Discussing Third Quarter 2024 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the third quarter ending September 30, 2024 on Thursday, October 31, 2024, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 17, 2024
Alnylam Submits Regulatory Application to the European Medicines Agency for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNA interference (RNAi) therapeutics company, today announced the submission of a Type II Variation to the European Medicines Agency (EMA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Vutrisiran is the generic name for AMVUTTRA®, which is currently approved in the European Union (EU) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 16, 2024
Alnylam Submits Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Vutrisiran for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the submission of its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Vutrisiran is the generic name for AMVUTTRA®, which is currently approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults. As part of the submission, the Company utilized a Priority Review Voucher, which obligates the FDA to an accelerated review timeline.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 9, 2024
Alnylam Highlights New Data From HELIOS-B Study of Vutrisiran for the Treatment of Transthyretin Amyloidosis With Cardiomyopathy at Heart Failure Society of America Annual Scientific Meeting 2024
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that two new data sets from the HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), were presented in the Late Breaking Clinical Research Session 1 at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2024, which was held virtually. An open access recording of Alnylam presentations will be available on the HFSA website following the session.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · September 29, 2024
Alnylam to Webcast TTR Investor Day
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will webcast its upcoming TTR Investor Day event on the Investors section of the Company’s website, www.alnylam.com, on Wednesday, October 9, 2024 at 8:30 am ET. A replay will be available on the Alnylam website within 48 hours after the event.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · September 26, 2024
Alnylam Presents Detailed Results from the Positive HELIOS-B Phase 3 Study of Vutrisiran▼ in Patients with ATTR Amyloidosis with Cardiomyopathy at the European Society of Cardiology Congress
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced detailed results from the HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · August 30, 2024
Alnylam to Webcast Presentations at Upcoming September Investor Conferences
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences:
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · August 28, 2024
Alnylam to Present Detailed Results from the HELIOS-B Phase 3 Study of Vutrisiran▼ in Patients with ATTR Amyloidosis with Cardiomyopathy at the European Society of Cardiology Congress 2024
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company will present results from the HELIOS-B Phase 3 study of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy at the European Society of Cardiology (ESC) Congress 2024, taking place in London, UK, on August 30 - September 2, 2024. The Company recently announced positive topline results of the study which met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular events, as well as all secondary endpoints, in both the overall population and in the monotherapy population, along with an acceptable safety profile and tolerability, consistent with its established profile. The Company will also host an Investor Webcast to discuss the HELIOS-B results on August 30, 2024. Vutrisiran is in development for the treatment of ATTR amyloidosis with cardiomyopathy.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · August 7, 2024
Alnylam Pharmaceuticals Reports Second Quarter 2024 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the second quarter ended June 30, 2024 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · August 1, 2024
Alnylam to Webcast Conference Call Discussing Second Quarter 2024 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the second quarter ending June 30, 2024 on Thursday, August 1, 2024, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · July 18, 2024
Alnylam Reports Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran, Achieving Statistical Significance on Primary and All Secondary Endpoints in Both Overall and Monotherapy Populations
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · June 24, 2024
Alnylam Issues 2023 Corporate Responsibility Report
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today the publication of its 2023 Corporate Responsibility Report. The company continues to take meaningful steps across each of its six corporate responsibility pillars. This year’s edition expands data disclosures across each pillar and highlights examples of the company’s commitment to ensuring patient access, reducing health inequities, and being a responsible steward of the environment.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · May 7, 2024
Alnylam Pharmaceuticals Reports First Quarter 2024 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the first quarter ended March 31, 2024 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · May 2, 2024
Alnylam to Webcast Conference Call Discussing First Quarter 2024 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the first quarter ending March 31, 2024 on Thursday, May 2, 2024, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · April 18, 2024
Alnylam Presents Positive Results from the KARDIA-2 Phase 2 Study of Zilebesiran Added to Standard of Care Antihypertensives in Patients with Inadequately Controlled Hypertension
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive results from the KARDIA-2 Phase 2 study evaluating the efficacy and safety of a single subcutaneous dose of zilebesiran when added to one of three standard of care antihypertensives including a thiazide-like diuretic (indapamide), calcium channel blocker (amlodipine) or angiotensin receptor blocker (olmesartan). Zilebesiran is an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension with the potential for biannual dosing. The results were presented today as a late-breaking clinical trial at the 2024 American College of Cardiology (ACC) Annual Scientific Session. The Company previously announced positive topline results from the KARDIA-2 study in March 2024.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · April 7, 2024
Alnylam to Webcast Investor Event to Discuss Results from KARDIA-2 Phase 2 Study of Zilebesiran at American College of Cardiology Scientific Session
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will host a webcast event to discuss results from the KARDIA-2 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension, at the American College of Cardiology (ACC) Scientific Session on Sunday, April 7, 2024 at 7:00 pm ET. The event will include presentations and a Q&A session with Alnylam management and Akshay Desai, M.D., Director of the Cardiomyopathy and Heart Failure Program, Brigham and Women’s Hospital.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · March 20, 2024
Alnylam Launches Hereditary ATTR (hATTR) Amyloidosis Campaign to Help Shorten Time to Diagnosis for Inherited and Rapidly Progressive Disease
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the launch of the Family Health History Road Trip, its program designed to encourage conversations between family members about their health history so they can discuss with their doctor to better understand their risk for developing an inherited disease like hereditary ATTR (hATTR) amyloidosis. Inspired by the traditional family road trip, the program follows genealogist and health educator Bernice Bennett as she embarks on a cross-country road trip to meet with a physician expert in hATTR amyloidosis and affected families to learn more about the disease, hear patients’ journeys to diagnosis and explore how knowledge of family health history can drive an earlier diagnosis.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · March 13, 2024
Alnylam Reports Positive KARDIA-2 Topline Study Results Demonstrating Clinically Significant Blood Pressure Reductions When Zilebesiran is Added to Standard of Care Antihypertensives
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the KARDIA-2 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension, met the primary endpoint showing that zilebesiran resulted in clinically and statistically significant additive, placebo-adjusted reductions in 24-hour mean systolic blood pressure (SBP) at Month 3 as measured by ambulatory blood pressure monitoring (ABPM) in each of three independent patient cohorts receiving the standardized background therapies of either a thiazide-like diuretic (indapamide), calcium channel blocker (amlodipine) or angiotensin receptor blocker (olmesartan). Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives. The Company believes these findings support further development.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · March 5, 2024
Alnylam to Webcast Presentations at Upcoming March Investor Conferences
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences:
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · February 27, 2024
Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the fourth quarter and full year ended December 31, 2023 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · February 15, 2024
Alnylam to Webcast Conference Call Discussing Fourth Quarter and Full Year 2023 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the fourth quarter and year ending December 31, 2023 on Thursday, February 15, 2024, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 29, 2024
Alnylam CEO Yvonne Greenstreet Named 2024 Woman of the Year by Healthcare Businesswomen’s Association
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, said today that Chief Executive Officer Yvonne Greenstreet has been selected as the 2024 Woman of the Year by the Healthcare Businesswomen’s Association (HBA). The announcement was made last evening at the J.P. Morgan Healthcare Conference in San Francisco. Yvonne will be recognized at HBA’s 34th annual Woman of the Year event on May 10 in New York City.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 9, 2024
Alnylam Announces Preliminary* Fourth Quarter and Full Year 2023 Global Net Product Revenues and Provides Additional Updates
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced its preliminary* fourth quarter and full year 2023 global net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO and provided additional updates on the products’ commercial launches.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 7, 2024
Alnylam to Webcast Presentation at 42nd Annual J.P. Morgan Healthcare Conference
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview and participate in a Q&A session at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 9:45 am PT (12:45 pm ET) at The Westin St. Francis in San Francisco. This presentation will include an update on unaudited fourth quarter and full year 2023 global net product revenues.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 2, 2024
Alnylam Highlights Significant Progress with Platform Innovation and Clinical Pipeline at R&D Day
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, is hosting a virtual R&D Day today. During the event, the Company plans to showcase its R&D progress and platform innovation, as well as its product and pipeline goals for 2024, including continued commercial execution of four RNAi therapeutic products and the advancement of early-, mid-, and late-stage investigational programs.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · December 13, 2023
Alnylam to Webcast Virtual R&D Day
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will webcast its upcoming virtual R&D Day event on the Investors section of the Company’s website, www.alnylam.com, on Wednesday, December 13, 2023 at 8:30 am ET. A replay will be available on the Alnylam website within 48 hours after the event.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · December 6, 2023
Alnylam Ranks #1 on Boston Globe’s Top Places to Work List for 2023
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced its first-place ranking in Boston Globe’s 2023 Top Places to Work in the “Largest Employer” category. This marks the third year in a row that Alnylam has taken the top spot in the Largest Employer category (> 1,000 employees).
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 30, 2023
Alnylam Presents Positive Results from the KARDIA-1 Phase 2 Dose-Ranging Study of Zilebesiran, an Investigational RNAi Therapeutic in Development for the Treatment of Hypertension in Patients at High Cardiovascular Risk
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive results from the KARDIA-1 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of patients with hypertension and high cardiovascular risk. The study results were presented during the American Heart Association (AHA) Scientific Sessions being held in Philadelphia, Pennsylvania from November 11-13, 2023. The Company previously announced positive topline results from the KARDIA-1 study in September 2023.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 11, 2023
Alnylam to Webcast Presentations at Upcoming November Investor Conferences
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences:
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 7, 2023
Alnylam Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter ended September 30, 2023 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 2, 2023
Alnylam Recognized by Science Magazine as Top Employer for Fifth Consecutive Year
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced its third place ranking in Science magazine’s Top Employer Survey for 2023. This marks the fifth year that Alnylam was featured as one of the top three companies in the annual survey of more than 6,800 professionals across biotechnology, biopharmaceuticals, and related industries.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 26, 2023
Alnylam Announces Publication of Results from APOLLO-B Phase 3 Study of Patisiran in Patients with the Cardiomyopathy of ATTR Amyloidosis in the New England Journal of Medicine
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that results from the APOLLO-B Phase 3 study of investigational patisiran in patients with the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis were published online in the New England Journal of Medicine (NEJM). The data reported in the APOLLO-B Phase 3 study publication demonstrate that patisiran, an RNAi therapeutic targeting transthyretin (TTR), preserved functional capacity and health status and quality of life compared with placebo at 12 months. In addition, treatment with patisiran demonstrated favorable effects on biomarkers of cardiac stress and injury and on measures of cardiac structure and function. The full manuscript, titled “Patisiran Treatment in Patients with Transthyretin Cardiac Amyloidosis,” will appear in the October 26, 2023 issue of NEJM.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 25, 2023
Alnylam Reports Additional Positive Interim Phase 1 Results for ALN-APP, in Development for Alzheimer’s Disease and Cerebral Amyloid Angiopathy
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced additional positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA). The data were presented today in a late-breaker session at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) conference, being held October 24-27, 2023, in Boston, MA. ALN-APP is the first clinical-stage program using Alnylam's proprietary C16-siRNA conjugate platform for central nervous system (CNS) delivery and the first investigational RNAi therapeutic to demonstrate gene silencing in the human brain. ALN-APP is being developed in collaboration with Regeneron.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 25, 2023
Alnylam to Webcast Conference Call Discussing Third Quarter 2023 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the third quarter ending September 30, 2023 on Thursday, November 2, 2023, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 19, 2023
Alnylam Announces Receipt of Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company’s supplemental New Drug Application (sNDA) for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 9, 2023
Alnylam to Present Additional Data for Patisiran in Patients With the Cardiomyopathy of ATTR Amyloidosis, Including 24-Month Results From the APOLLO-B Phase 3 Study, at the Heart Failure Society of America Annual Scientific Meeting 2023
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Company will present new results for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis, at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2023, October 6-9, 2023. Data from an interim analysis of the ongoing open-label extension (OLE) period of the APOLLO-B Phase 3 study of patisiran in patients with the cardiomyopathy of ATTR amyloidosis through 24 months will be presented. In addition, findings from a post-hoc analysis of the APOLLO-B Phase 3 study that further characterize the impact of patisiran on health status and quality of life in patients with the cardiomyopathy of ATTR amyloidosis will be presented, as well as demographics, baseline characteristics and safety data for patients who enrolled in the expanded access program (EAP) for patisiran.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 6, 2023
Alnylam Announces Positive Outcome of FDA Advisory Committee Meeting on Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the positive outcome of the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting to discuss the supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. The CRDAC voted 9:3 that the benefits of patisiran outweigh its risks for the treatment of the cardiomyopathy of ATTR amyloidosis.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · September 13, 2023
Alnylam Stock Trading Halted Today; FDA Advisory Committee to Review Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that NASDAQ has halted trading of the Company’s common stock.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · September 13, 2023
Alnylam Reports Positive Topline Results from KARDIA-1 Phase 2 Dose-Ranging Study of Zilebesiran, an Investigational RNAi Therapeutic in Development to Treat Hypertension in Patients at High Cardiovascular Risk
Alnylam Pharmaceuticals, Inc. Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the KARDIA-1 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension, met the primary endpoint demonstrating a dose-dependent, clinically significant reduction in 24-hour mean systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) at Month 3, achieving a placebo-subtracted reduction greater than 15 mmHg (p less than 0.0001) with both 300 mg and 600 mg doses. The study also met key secondary endpoints including significant change in 24-hour mean SBP as measured by ABPM at Month 6, as well as significant change in office SBP at Month 3 and Month 6, for all zilebesiran arms, compared to placebo. The study results indicate zilebesiran was associated with dose-dependent, potent and durable knockdown of serum AGT levels through Month 6. Zilebesiran also demonstrated an encouraging safety and tolerability profile that the company believes supports continued development. These findings of robust and tonic blood pressure control will help determine the optimal dose and regimen of zilebesiran for future studies.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · September 7, 2023
Alnylam to Appeal Claim Construction Ruling on Two Patents Asserted Against Moderna
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced an update on its ongoing patent infringement litigation. On March 17, 2022, Alnylam initiated litigation in the United States District Court for the District of Delaware against Moderna for patent infringement. To date, in two separate actions against Moderna, Alnylam has sought to recover reasonable compensation for Moderna’s infringement of five Alnylam patents that cover key lipid technology embedded in Moderna’s COVID-19 Vaccine, SPIKEVAX®.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · August 25, 2023
Alnylam to Webcast Presentation at Canaccord Genuity 43rd Annual Growth Conference
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the Canaccord Genuity 43rd Annual Growth Conference on Thursday, August 10, 2023 at 10:30 am ET at the InterContinental Hotel in Boston.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · August 2, 2023
Alnylam Announces Partnership with Roche to Co-Develop and Co-Commercialize Zilebesiran, an Investigational RNAi Therapeutic for the Treatment of Hypertension in Patients with High Cardiovascular Risk
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced it has entered into a strategic agreement with Roche to develop and commercialize zilebesiran, Alnylam’s investigational RNAi therapeutic for the treatment of hypertension, which is currently in Phase 2 of development. The partnership allows for a bold development plan with the goal of disrupting the hypertension treatment paradigm globally while advancing Alnylam’s P5x25 strategy.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · July 24, 2023
Alnylam to Webcast Conference Call Discussing Second Quarter 2023 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the second quarter ending June 30, 2023 on Thursday, August 3, 2023, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · July 20, 2023
Alnylam Announces Publication of Phase 1 Study Results for Zilebesiran in the New England Journal of Medicine
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that results from its Phase 1 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension, were published in the New England Journal of Medicine (NEJM). The full manuscript is titled, “Zilebesiran, an RNA Interference Therapeutic Agent for Hypertension,” and will appear in the July 20, 2023 issue of NEJM. The key data reported in the publication showed that in the Phase 1 study, compared to placebo, zilebesiran was associated with dose-dependent reductions in serum AGT, achieving tonic blood pressure control with consistent and durable blood pressure reduction throughout a 24-hour period, sustained up to six months after single doses of ≥200 mg of zilebesiran. Zilebesiran also demonstrated an acceptable safety profile supporting continued clinical development; the most frequent treatment-related adverse events were mild, transient injection-site reactions.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · July 19, 2023
Alnylam Announces Date of Planned FDA Advisory Committee Meeting for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has set a date of September 13, 2023 for the meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the supplemental New Drug Application for patisiran, an investigational treatment for the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. As previously announced, the FDA has set an action date of October 8, 2023 under the Prescription Drug User Fee Act. An advanced display of the public notice is available in the Federal Register here.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · June 30, 2023
Alnylam to Webcast Presentation at Goldman Sachs 44th Annual Global Healthcare Conference
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12, 2023 at 8:00 am PT (11:00 am ET) at the Waldorf Astoria Monarch Beach Resort & Club in Dana Point, CA.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · June 5, 2023
Alnylam Pharmaceuticals Reports First Quarter 2023 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the first quarter ended March 31, 2023 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · May 4, 2023
Alnylam to Webcast Presentation at BofA Securities 2023 Health Care Conference
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the BofA Securities 2023 Health Care Conference on Wednesday, May 10, 2023 at 1:40 pm PT (4:40 pm ET) at the Encore Hotel in Las Vegas.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · May 3, 2023
Alnylam Issues 2022 Corporate Responsibility Report
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today published its 2022 Corporate Responsibility Report. This year’s edition reasserts our commitment to advancing pioneering RNAi science and supporting health equity. The company continues to take meaningful steps across each of our six corporate responsibility pillars to ensure everyone has access to essential health services and medicines. As the company further these efforts, it will regularly communicate its progress.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · May 3, 2023
Alnylam and Regeneron Report Positive Interim Phase 1 Clinical Data on ALN-APP, an Investigational RNAi Therapeutic for Alzheimer’s Disease and Cerebral Amyloid Angiopathy
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today positive interim results from the ongoing single ascending dose part of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA).
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · April 26, 2023
Alnylam to Webcast Conference Call Discussing First Quarter 2023 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the first quarter ending March 31, 2023 on Thursday, May 4, 2023, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · April 20, 2023
Alnylam Announces Appointment of Peter Kellogg to Board of Directors
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) the leading RNAi therapeutics company, announced today the appointment of Peter Kellogg to its Board of Directors. Mr. Kellogg is an accomplished industry executive with extensive global financial and strategic management experience.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · March 8, 2023
Alnylam to Webcast Presentations at Upcoming March Investor Conferences
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences:
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · March 1, 2023
Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the fourth quarter and full year ended December 31, 2022 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · February 23, 2023
Alnylam Announces U.S. Food and Drug Administration (FDA) Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. The FDA has set an action date of October 8, 2023 under the Prescription Drug User Fee Act (PDUFA). In their file acceptance letter, the FDA stated that they have not identified any review issues. The Agency also noted that they are planning to hold an advisory committee meeting to discuss the application. Patisiran is the established name for ONPATTRO®, which is currently approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · February 21, 2023
Alnylam to Webcast Conference Call Discussing Fourth Quarter and Full Year 2022 Financial Results
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will report financial results for the fourth quarter and year ending December 31, 2022 on Thursday, February 23, 2023, before the U.S. financial markets open.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · February 2, 2023
Alnylam Announces Preliminary* Fourth Quarter and Full Year 2022 Global Net Product Revenues and Provides Additional Updates
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced its preliminary* fourth quarter and full year 2022 global net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO and provided additional updates on the products’ commercial launches.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 8, 2023
Alnylam Announces Updates to its Board of Directors
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) the leading RNAi therapeutics company, today announces appointment of Carolyn Bertozzi, Ph.D. a Nobel Laureate to the Board. Dr. Bertozzi is known is known for her work in chemical biology. She is a pioneer for emerging technology and has founded ten biopharmaceutical companies and guided more than a dozen academic and professional organizations and life sciences companies in leadership and board positions.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 5, 2023
Alnylam to Webcast Presentation at 41st Annual J.P. Morgan Healthcare Conference
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview and participate in a Q&A session at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 9:45 am PT (12:45 pm ET) at The Westin St. Francis in San Francisco. This presentation will include an update on unaudited fourth quarter and full year 2022 global net product revenues.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · January 3, 2023
Alnylam Submits CTA Application for ALN-KHK, an Investigational RNAi Therapeutic for the Treatment of Type 2 Diabetes
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health Canada to initiate a Phase 1/2 study of ALN-KHK, an investigational RNAi therapeutic targeting ketohexokinase (KHK) for the treatment of Type 2 diabetes mellitus (T2DM). Pending regulatory authority and ethic committee approvals, the Company plans to begin enrollment in a Phase 1/2 study in healthy overweight to obese volunteers and obese patients with T2DM in early 2023, and expects to report initial human data in late 2023.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · December 21, 2022
Alnylam Submits Supplemental New Drug Application (sNDA) to U.S. Food and Drug Administration (FDA) for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the submission of its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy. Patisiran is the established name for ONPATTRO®, which is currently approved by the U.S. FDA for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · December 8, 2022
Alnylam to Webcast Virtual R&D Day
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will webcast its upcoming virtual R&D Day event on the Investors section of the Company’s website, www.alnylam.com, on December 15, 2022 at 8:30 am ET. A replay will be available on the Alnylam website within 48 hours after the event.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · December 8, 2022
Alnylam Ranks #1 on Boston Globe’s Top Places to Work List for 2022
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced its first-place ranking in Boston Globe’s 2022 Top Places to Work in the “Largest Employer” category. This marks the second year in a row Alnylam’s takes the top spot in the Largest Employer category (> 1,000 employees).
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · December 1, 2022
Alnylam to Webcast Presentations at Upcoming November Investor Conferences
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences:
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · November 9, 2022
Alnylam Recognized by Science Magazine as Top Employer for Fourth Consecutive Year
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced its second place ranking in Science Magazine’s 2022 Top Employer Survey. This marks the fourth year Alnylam was featured as one of the top three companies in the annual survey of more than 6,200 professionals across biotechnology, biopharmaceuticals and related industries.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 27, 2022
Alnylam Pharmaceuticals Reports Third Quarter 2022 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter ended September 30, 2022 and reviewed recent business highlights.
By Alnylam Pharmaceuticals, Inc. · Via Business Wire · October 27, 2022