Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, focuses on discovering, developing, and commercializing RNA interference (RNAi) therapeutics. The company's pipeline of investigational RNAi therapeutics focus on genetic medicines, cardio-metabolic diseases, hepatic infectious diseases, and central nervous system (CNS)/ocular diseases. Its marketed products include ONPATTRO (patisiran), a lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults; GIVLAARI for the treatment of adults with acute hepatic porphyria (AHP); and OXLUMO (lumasiran) for the treatment of primary hyperoxaluria type 1 (PH1). In addition, the company is developing givosiran for the treatment of adolescent patients with AHP; lumasiran for the treatment of advanced PH1 and recurrent renal stones; patisiran for the treatment of transthyretin amyloidosis, or ATTR amyloidosis, with cardiomyopathy; and vutrisiran for the treatment of ATTR amyloidosis. Alnylam Pharmaceuticals, Inc. has strategic collaborations with Regeneron Pharmaceuticals, Inc. to discover, develop, and commercialize RNAi therapeutics for a range of diseases by addressing therapeutic targets expressed in the eye and CNS; and Sanofi Genzyme to discover, develop, and commercialize RNAi therapeutics. It also has license and collaboration agreements with Novartis AG; Vir Biotechnology, Inc.; Dicerna Pharmaceuticals, Inc.; Ionis Pharmaceuticals, Inc.; and PeptiDream, Inc. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts.
IPO Year: 2004
Exchange: NASDAQ
Website: alnylam.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 11/12/2024 | Peer Perform → Underperform | Wolfe Research | |
| 10/16/2024 | Sector Outperform | Scotiabank | |
| 8/16/2024 | $198.00 → $370.00 | Neutral → Buy | Goldman |
| 2/16/2024 | $173.00 | Buy → Neutral | Goldman |
| 2/15/2024 | Peer Perform | Wolfe Research | |
| 12/8/2023 | $171.00 | Equal Weight | Wells Fargo |
| 12/8/2023 | Equal Weight | Wells Fargo | |
| 10/11/2023 | Outperform → Perform | Oppenheimer | |
| 9/29/2023 | $208.00 | Outperform | Raymond James |
| 5/5/2023 | $200.00 → $250.00 | Market Perform → Outperform | BMO Capital Markets |
Wolfe Research downgraded Alnylam Pharma from Peer Perform to Underperform
Scotiabank initiated coverage of Alnylam Pharma with a rating of Sector Outperform
Goldman upgraded Alnylam Pharma from Neutral to Buy and set a new price target of $370.00 from $198.00 previously
Goldman downgraded Alnylam Pharma from Buy to Neutral and set a new price target of $173.00
Wolfe Research initiated coverage of Alnylam Pharma with a rating of Peer Perform
Wells Fargo initiated coverage of Alnylam Pharma with a rating of Equal Weight and set a new price target of $171.00
Wells Fargo initiated coverage of Alnylam Pharma with a rating of Equal Weight
Oppenheimer downgraded Alnylam Pharma from Outperform to Perform
Raymond James initiated coverage of Alnylam Pharma with a rating of Outperform and set a new price target of $208.00
BMO Capital Markets upgraded Alnylam Pharma from Market Perform to Outperform and set a new price target of $250.00 from $200.00 previously
− Achieved Third Quarter 2024 Global Net Product Revenues of $420 Million, Representing 34% Year-Over-Year Growth Compared to Q3 2023, Driven by Continued Momentum from TTR Business – − Submitted Regulatory Applications in U.S. and EU for AMVUTTRA® (vutrisiran) for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy – − Reiterated 2024 Financial Guidance, Including Combined Net Product Revenues of $1,575 Million to $1,650 Million – 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. "Alnylam continued to deli
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. Management will provide an update on the Company and discuss third quarter 2024 results as well as expectations for the future via conference call on Thursday, October 31, 2024 at 8:30 am ET. A live audio webcast of the call will be available on the Investors section of the Company's website at www.alnylam.com/events. An archived webcast will be available on the Alnylam website approximately two hours after the event. About Alnylam Phar
− In the Overall Population, Achieved 28% Reduction in Primary Composite of All-Cause Mortality and Recurrent Cardiovascular Events, and 31% and 36% Reductions in All-Cause Mortality During the 33-36-Month Double-Blind Period and up to Month 42, Respectively – − In the Monotherapy Population, Reduced Composite Primary Endpoint by 33% and All-Cause Mortality up to Month 42 by 35% – − Strong Trends of Additive Efficacy on Top of Tafamidis Across Primary and Secondary Endpoints – − Demonstrated Statistically Significant Benefits on Multiple Measures of Disease Progression – − Encouraging Safety and Tolerability Profile, Consistent with Established Profile – − Results from HELIOS-B Si
– Company to Host Conference Call on August 30, 2024, at 1:00 p.m. (BST), 8:00 a.m. (ET) to Discuss Results – 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
− Achieved Second Quarter 2024 Global Net Product Revenues of $410 Million, Representing 34% Year-Over-Year Growth Compared to Q2 2023, Driven by Continued Momentum from TTR Business, Which Delivered 37% Year-Over-Year Growth – − Reported 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 – − Updated 2024 Financial Guidance, Including Increased Combined Net Product Revenue Guidance from $1,400 Million - $1,500 Million to $1,575 Million - $1,650 Million – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today reported
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. Management will provide an update on the Company and discuss second quarter 2024 results as well as expectations for the future via conference call on Thursday, August 1, 2024 at 8:30 am ET. A live audio webcast of the call will be available on the Investors section of the Company's website at www.alnylam.com/events. An archived webcast will be available on the Alnylam website approximately two hours after the event. About Alnylam Pharmaceu
− Achieved 28% and 33% Reduction in Composite of All-Cause Mortality and Recurrent Cardiovascular Events in the Overall and Monotherapy Populations, Respectively – − Reduced All-Cause Mortality by 36% and 35% in the Overall and Monotherapy Populations, Respectively, in a Pre-Specified Secondary Endpoint – − Demonstrated Clinically Significant Benefits on 6-Minute Walk Test, Kansas City Cardiomyopathy Questionnaire and NYHA Class – Key Measures of Disease Progression – − Observed Consistent Effects in All Key Subgroups, Including Baseline Tafamidis – − Demonstrated Encouraging Safety, Consistent with Established Profile – − Alnylam to File a U.S. Supplemental New Drug Application U
− Achieved First Quarter 2024 Global Net Product Revenues of $365 Million, Representing 32% Year-Over-Year Growth Compared to Q1 2023, Including Continued Momentum from Total TTR Delivering 29% Year-Over-Year Growth – − Demonstrated Strong Progress with Zilebesiran Hypertension Program with Positive Results from KARDIA-2 Phase 2 Study and Initiation of KARDIA-3 Phase 2 Study – − Remain on Track to Report Topline Results from HELIOS-B Phase 3 Study of Vutrisiran in Late June or Early July – − Reiterated 2024 Financial Guidance, Including Combined Net Product Revenues of $1,400 Million to $1,500 Million – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics compa
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. Management will provide an update on the Company and discuss first quarter 2024 results as well as expectations for the future via conference call on Thursday, May 2, 2024 at 8:30 am ET. To access the call, please register online at https://register.vevent.com/register/BI0abdd195e81a43d9ac0c44fe9d789f86. Participants are requested to register a day in advance or at a minimum 15 minutes before the start of the call. A replay of the call will be a
− Achieved Fourth Quarter and Full Year 2023 Global Net Product Revenues of $346 Million and $1,241 Million, Respectively, Representing 39% Annual Growth Compared to 2022 – − Company Announces Updated Statistical Analysis Plan and Timing for HELIOS-B Phase 3 Study of Vutrisiran – − Announces U.S. FDA Clearance to Initiate Multiple-Dosing in ALN-APP Phase 1 Study – − Provides 2024 Combined Net Product Revenue Guidance of $1,400 Million to $1,500 Million, in Addition to Collaboration and Royalty Revenue and Operating Expense Guidance – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the fourth qu
– Full Year 2024 Preliminary Net Product Revenues of $1,646 Million for ONPATTRO®, AMVUTTRA®, GIVLAARI®, and OXLUMO®, Representing 33% Annual Growth – – 2025 Combined Net Product Revenue Guidance** of $2,050 Million to $2,250 Million Positions Company to Achieve Alnylam P5x25 Goal of Non-GAAP Profitability – – Robust Clinical Pipeline with Multi-Billion-Dollar Opportunities for Sustainable Growth – 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-GA
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. A live audio webcast of both the presentation and Q&A session will be available on the Investors section of the Company's website, www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after the event
GIVLAARI is the first and only therapy in Canada proven to prevent AHP attacks, reduce chronic pain and improve quality of life1 MISSISSAUGA, ON, Dec. 23, 2024 /CNW/ - Alnylam Canada ULC is pleased to announce that GIVLAARI® (givosiran injection) is now funded across Canada through both public and private insurance plans for patients living with acute hepatic porphyria (AHP), including those diagnosed with acute intermittent porphyria (AIP) - the most common type of AHP. GIVLAARI is approved by Health Canada for the treatment of acute hepatic porphyria (AHP) in adults.1 It is the first and only therapy in Canada that is proven to prevent AHP attacks, reduce chronic pain and improve quality
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. A live audio webcast of the presentation will be available on the Investors section of the Company's website at www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after the event. About Alnylam Pharmaceuticals Alnylam Pharmaceuticals (NASDAQ:ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the
− Prescription Drug User Fee Act (PDUFA) Date Set for March 23, 2025 − 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 th
− Single Dose of Nucresiran 300mg or Higher Led to Rapid Knockdown of Mean TTR Levels of Greater than 90% by Day 15 that was Sustained at Six Months − − At These Doses, Peak Reduction of Mean TTR Levels of Greater than 96% were Achieved by Day 29 − − Data Support Potential for Biannual or Annual Subcutaneous Dosing, Representing a New Paradigm in the Treatment of ATTR Amyloidosis − − Encouraging Safety and Tolerability Observed − − Alnylam Continues to Expect to Share Phase 3 Development Plans in Q1 2025 – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today announced the presentation of new results from its Phase 1 study of nucresiran (formerl
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, announced today that management will present company overviews at the following conferences: UBS Global Healthcare Conference on Tuesday, November 12, 2024 at 8:45 am PT (11:45 ET) at the Terranea Resort in Ranchos Palos Verdes, CA Jefferies London Healthcare Conference on Wednesday, November 20, 2024 at 9:30 am GMT (4:30 am ET) in London A live audio webcast of each presentation will be available on the Investors section of the Company's website at www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after each event. About Alnylam Pharmaceuticals Alnylam Pharmac
− Achieved Third Quarter 2024 Global Net Product Revenues of $420 Million, Representing 34% Year-Over-Year Growth Compared to Q3 2023, Driven by Continued Momentum from TTR Business – − Submitted Regulatory Applications in U.S. and EU for AMVUTTRA® (vutrisiran) for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy – − Reiterated 2024 Financial Guidance, Including Combined Net Product Revenues of $1,575 Million to $1,650 Million – 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. "Alnylam continued to deli
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. Data presentations for the Company's flagship TTR franchise include new findings from an analysis of the HELIOS-B Phase 3 study of vutrisiran, an RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), as well as interim results from a Phase 1 study evaluating ALN-TTRsc04, a next generation RNAi therapeutic in development for the treatment of ATTR amy
One step closer to achieving public reimbursement of AMVUTTRA® for hATTR patients in Canada MISSISSAUGA, ON, Oct. 18, 2024 /CNW/ - Alnylam Canada ULC is pleased to announce that it has signed a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) for the public reimbursement of AMVUTTRA® (vutrisiran injection), an RNAi therapeutic administered by quarterly subcutaneous injection, for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).1 This comes following a positive recommendation from the Canadian Drug Agency (CDA) and the Institut national d'excellence en santé et services socia
As former leader of Pfizer's infant nutrition and consumer healthcare businesses, Schulman brings extensive experience in the space, in addition to serving on the boards of several biotech and pharmaceutical companies; This marks ByHeart's first non-executive Board chair appointment In addition to Schulman, ByHeart appoints Niall Mullane, PhD, as Chief Quality Officer to join the experienced executive team; Mullane brings 15 years of quality and food safety experience in the infant nutrition category NEW YORK, March 5, 2024 /PRNewswire/ --Today, ByHeart, the next-generation baby nutrition company, announced the appointment of Amy Schulman, managing partner at Polaris partners, as Chair of th
– Experienced Business and Financial Leader, Kellogg Served as Chief Financial Officer at Biogen, Merck, and Celgene – 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. "Mr. Kellogg joins our Board at a pivotal moment for Alnylam as we continue on the path to achieving our P5x25 strategy and fulfilling our ambition to become a top-tier biopharmaceutical company," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "His financial expertise and experi
– Achieved Full Year 2022 Preliminary Global Net Product Revenues of $894 Million for ONPATTRO®, AMVUTTRA®, GIVLAARI®, and OXLUMO®, Representing 35% Annual Growth (43% Using Constant Exchange Rate**) – – Strength of AMVUTTRA Launch Drove 37% Total TTR Annual Revenue Growth – – Maintained Strong Balance Sheet with Year-End Cash and Investments Balance of Approximately $2.2 Billion – 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. Preliminary Four
– Appoints Carolyn Bertozzi, Ph.D., Nobel Laureate and Leading Voice for Chemical Biology, Emerging Technology, and Life Sciences Companies – – Michael W. Bonney Steps Down as Executive Chair and Continues on Board as Non-Independent Director – – Amy W. Schulman will Assume Role of Chair of the Board – 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
– Company Expects to Initiate a Phase 1/2 Study for ALN-KHK in Early 2023, with Initial Results Expected in Late 2023 – 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
− Product and Pipeline Goals Detail Execution across Four Commercial Brands, Including One Potential Label Expansion, and Ten Clinical Data Readouts From Proprietary and Partner Programs – − Pipeline Programs and Scientific Innovation Highlighted at R&D Day Exemplify Strength of RNAi Platform and Organic Product Engine – − Alnylam to Webcast its R&D Day Event Today at 8:30 a.m. ET – 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 2023 focused on continued commercial execution of four
– sNDA Submission is Based on Findings from the APOLLO-B Phase 3 Study That Showed Patisiran Demonstrated Significant Improvement on Functional Capacity, Health Status and Quality of Life Compared to Placebo at Month 12 – – Study Also Demonstrated Encouraging Safety Profile in Patients with 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. Patisira
- OXLUMO Now Indicated for the Treatment of Primary Hyperoxaluria Type 1 (PH1) to Lower Urinary and Plasma Oxalate Levels in Pediatric and Adult Patients - - Approval is Based on Positive Efficacy and Safety Results of the ILLUMINATE-C Phase 3 Study of OXLUMO in PH1 Patients with Severe Renal Impairment, Including Those on Hemodialysis - Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved a label expansion for OXLUMO® (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate
– Piyush Sharma to Serve as Chief Ethics and Compliance Officer and Evan Lippman as Chief Corporate Development and Strategy Officer – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today announced the appointment of two new members to the management team – Piyush Sharma as Chief Ethics & Compliance Officer (CECO), and Evan Lippman in the newly created role of Chief Corporate Development and Strategy Officer (CDSO). Both executives will report to Chief Executive Officer, Yvonne Greenstreet. "Attracting and retaining top talent is one of my top priorities, and I'm thrilled that Piyush and Evan are joining our team. Piyush brings valuable experience buil
– AMVUTTRA Demonstrated Halting or Reversal in Neuropathy Impairment with Subcutaneous Administration Once Every Three Months – – Decision Follows Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2022 – Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY), the leading RNAi therapeutics company, today announced that the European Commission (EC) has granted marketing authorization for AMVUTTRA® (vutrisiran), an RNAi therapeutic for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. The EC approval is based on positive 18-month results from the HELIOS-A
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Submission status for ALNYLAM PHARMS INC's drug GIVLAARI (SUPPL-7) with active ingredient GIVOSIRAN SODIUM has changed to 'Approval' on 04/29/2024. Application Category: NDA, Application Number: 212194, Application Classification: Labeling
Submission status for ALNYLAM PHARMS INC's drug OXLUMO (SUPPL-4) with active ingredient LUMASIRAN SODIUM has changed to 'Approval' on 09/19/2023. Application Category: NDA, Application Number: 214103, Application Classification: Labeling
Submission status for ALNYLAM PHARMS INC's drug AMVUTTRA (SUPPL-2) with active ingredient VUTRISIRAN has changed to 'Approval' on 02/16/2023. Application Category: NDA, Application Number: 215515, Application Classification: Labeling
Submission status for ALNYLAM PHARMS INC's drug GIVLAARI (SUPPL-5) with active ingredient GIVOSIRAN SODIUM has changed to 'Approval' on 02/10/2023. Application Category: NDA, Application Number: 212194, Application Classification: Labeling
Submission status for ALNYLAM PHARMS INC's drug ONPATTRO (SUPPL-12) with active ingredient PATISIRAN SODIUM has changed to 'Approval' on 01/13/2023. Application Category: NDA, Application Number: 210922, Application Classification: Efficacy
Submission status for ALNYLAM PHARMS INC's drug OXLUMO (SUPPL-3) with active ingredient LUMASIRAN SODIUM has changed to 'Approval' on 10/06/2022. Application Category: NDA, Application Number: 214103, Application Classification: Efficacy
Submission status for ALNYLAM PHARMS INC's drug ONPATTRO (SUPPL-13) with active ingredient PATISIRAN SODIUM has changed to 'Approval' on 10/03/2022. Application Category: NDA, Application Number: 210922, Application Classification: Labeling
Submission status for ALNYLAM PHARMS INC's drug ONPATTRO (SUPPL-13) with active ingredient PATISIRAN SODIUM has changed to 'Approval' on 10/04/2022. Application Category: NDA, Application Number: 210922, Application Classification: Labeling
Submission status for ALNYLAM PHARMS INC's drug AMVUTTRA (ORIG-1) with active ingredient VUTRISIRAN has changed to 'Approval' on 06/13/2022. Application Category: NDA, Application Number: 215515, Application Classification: Type 1 - New Molecular Entity
Submission status for ALNYLAM PHARMS INC's drug GIVLAARI (SUPPL-4) with active ingredient GIVOSIRAN SODIUM has changed to 'Approval' on 10/28/2021. Application Category: NDA, Application Number: 212194, Application Classification: Labeling