Welcome to our dedicated page for Alnylam Pharmaceuticals news (Ticker: ALNY), a resource for investors and traders seeking the latest updates and insights on Alnylam Pharmaceuticals stock.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) regularly issues news on its RNA interference (RNAi) therapeutics, commercial performance, pipeline progress, and corporate developments. As a company that has led the RNAi field from discovery to approved medicines, its announcements often highlight data from pivotal trials, regulatory milestones, and updates on marketed products such as AMVUTTRA, ONPATTRO, GIVLAARI, and OXLUMO.
Investors following ALNY news can expect detailed coverage of clinical results across multiple therapeutic areas, including transthyretin‑mediated amyloidosis (ATTR), hypertension, bleeding disorders, neurological diseases, and metabolic conditions. Recent releases have described post hoc analyses from the HELIOS‑B Phase 3 study of AMVUTTRA in ATTR‑CM and hATTR‑PN, showing effects on gastrointestinal events, cardiac structure and function, and renal outcomes, as well as broader safety and efficacy profiles.
Alnylam’s news flow also includes financial and strategic updates. The company reports quarterly and annual net product revenues, trends in its TTR and rare disease franchises, and guidance associated with frameworks such as its Alnylam P5x25 and Alnylam 2030 strategies. Filings and press releases have discussed convertible senior notes, a revolving credit facility, and partial repurchases of outstanding debt, providing context on capital structure and liquidity.
Operational and manufacturing developments are another key news theme. Alnylam has announced expansion of its Norton, Massachusetts siRNA manufacturing facility and the integration of its siRELIS enzymatic ligation platform, which has been accepted into the FDA’s Emerging Technology Program. Corporate governance items, such as changes to the Board of Directors and executive responsibilities, are also disclosed. For anyone tracking ALNY, this news stream offers insight into clinical milestones, commercial execution, manufacturing scale‑up, and strategic direction in RNAi therapeutics.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has announced a private offering of $500 million convertible senior notes due 2028 to qualified institutional buyers. The company also granted initial purchasers an option for an additional $75 million in notes.
The notes will be senior, unsecured obligations with semi-annual interest payments, convertible to cash, common stock, or a combination at Alnylam's discretion. The company plans to enter into capped call transactions to reduce potential dilution and will use proceeds to repurchase a portion of its existing 1.00% convertible notes due 2027, with remaining funds for general corporate purposes.
Alnylam Pharmaceuticals (Nasdaq: ALNY) presented new long-term data from the HELIOS-B Phase 3 study of AMVUTTRA® (vutrisiran) at ESC Congress 2025. The results demonstrate sustained benefits through 48 months in treating ATTR-CM (transthyretin-mediated amyloidosis with cardiomyopathy).
Key findings show vutrisiran reduced the risk of all-cause mortality or first cardiovascular event by 37% in the overall population and 42% in the monotherapy group. The drug maintained improvements in quality of life measures and cardiac biomarkers during the 12-month open-label extension period. The study included 654 patients, with 466 entering the extension phase.
The safety profile remained consistent with previous findings, with no new concerns identified. The data supported recent approvals in multiple regions including the US, EU, Japan, and UK, making AMVUTTRA the first RNAi therapeutic approved for both cardiomyopathy and polyneuropathy manifestations of ATTR amyloidosis.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced plans to initiate ZENITH, a Phase 3 cardiovascular outcomes trial for zilebesiran, following promising KARDIA-3 Phase 2 results. The trial will evaluate zilebesiran's potential to reduce major adverse cardiovascular events in approximately 11,000 patients.
The KARDIA-3 study showed that a 300 mg dose of zilebesiran achieved clinically meaningful blood pressure reductions at Month 3 (-5.0 mmHg; p=0.0431) with sustained benefits through Month 6 (-3.9 mmHg). Enhanced effects were observed in patients on diuretics, with SBP reductions of at least 8 mmHg sustained for six months. The drug demonstrated an encouraging safety profile when combined with multiple background therapies.
The global Phase 3 ZENITH trial is expected to initiate by year-end 2025, evaluating zilebesiran (300 mg) administered every six months versus placebo in patients with uncontrolled hypertension and high cardiovascular risk.
Genentech (OTCQX:RHHBY) and Alnylam announced plans to advance zilebesiran into a Phase III cardiovascular outcomes trial (CVOT) for uncontrolled hypertension treatment. The decision follows positive results from the comprehensive KARDIA Phase II program, particularly KARDIA-3 study results presented at ESC Congress 2025.
The KARDIA-3 study demonstrated that zilebesiran (300mg) achieved clinically meaningful blood pressure reductions at month three (-5.0 mmHg; p=0.0431) with sustained benefits through month six. Notably, patients on diuretics with baseline BP >140 mmHg showed significant improvements (-9.2 mmHg at month three).
The upcoming global ZENITH Phase III trial will enroll approximately 11,000 patients, evaluating zilebesiran (300mg) versus placebo in patients with uncontrolled hypertension on multiple antihypertensives. The twice-yearly dosing schedule aims to address poor adherence issues affecting up to 80% of hypertension patients worldwide.
Alnylam Pharmaceuticals (Nasdaq: ALNY), a leader in RNAi therapeutics, has announced its participation in three major investor conferences in September 2025. The company will present at Citi's 2025 Biopharma Back to School Conference (September 3), Morgan Stanley 23rd Annual Global Healthcare Conference (September 8), and Bernstein Insights: Healthcare Leaders and Disruptors Forum (September 23).
All presentations will be available via live audio webcast on Alnylam's website, with replays accessible within 48 hours after each event.
Alnylam Pharmaceuticals (Nasdaq: ALNY) will present new data from its cardiovascular disease programs at the European Society of Cardiology (ESC) Congress 2025 in Madrid from August 29 - September 1, 2025. The presentations will feature data from two key programs:
1. The KARDIA-3 Phase 2 study of zilebesiran for uncontrolled hypertension, to be presented as a late-breaking abstract.
2. New analyses from the HELIOS-B Phase 3 study of AMVUTTRA® (vutrisiran) in ATTR amyloidosis patients, including 12-month follow-up data and analysis of days lost to death and/or hospitalization.
The company will host an investor webcast to discuss the KARDIA-3 results on August 30, 2025, at 1:00 p.m. ET.
Alnylam Pharmaceuticals (Nasdaq: ALNY), a leader in RNAi therapeutics, has announced its upcoming participation in the Canaccord Genuity 45th Annual Growth Conference. The company's management will deliver a corporate overview presentation on Tuesday, August 12, 2025, at 8:00 am ET.
Investors and interested parties can access a live audio webcast of the presentation through the Investors section of Alnylam's website. A replay will be made available within 48 hours following the event.
Alnylam Pharmaceuticals (Nasdaq: ALNY) reported strong Q2 2025 financial results, with total net product revenues of $672 million, representing 64% growth year-over-year. The growth was primarily driven by the TTR franchise, which generated $544 million in revenues (77% growth vs Q2 2024), including AMVUTTRA's successful ATTR-CM launch with approximately 1,400 patients.
The company secured multiple global regulatory approvals for AMVUTTRA in ATTR-CM, including in the EU, Brazil, UK, and Japan. Based on strong H1 2025 performance, Alnylam raised its 2025 guidance, projecting TTR franchise revenues of $2.175-$2.275 billion and total net product revenues of $2.65-$2.8 billion, a 27% increase at midpoint.
Q2 2025 financial highlights include total revenues of $773.7 million (17% growth) and a GAAP net loss of $0.51 per share. The company maintained a strong financial position with $2.86 billion in cash and investments as of June 30, 2025.
Alnylam Pharmaceuticals (Nasdaq: ALNY), a leader in RNAi therapeutics, has scheduled its second quarter 2025 financial results announcement for Thursday, July 31, 2025, before U.S. markets open.
Management will host a conference call at 8:30 AM ET on the same day to discuss Q2 results and future outlook. Investors can access the live audio webcast through the Investors section at www.alnylam.com/events, with an archived version available approximately two hours after the event.