Alnylam Pharmaceuticals Inc Stock Price, News & Analysis

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.

Alnylam Pharmaceuticals (ALNY) has promoted Pushkal Garg, M.D., to Executive Vice President, Chief Research and Development Officer to lead an integrated R&D organization. Following the successful launch of AMVUTTRA for ATTR-CM, this strategic move aims to accelerate pipeline development through enhanced collaboration and faster decision-making. Dr. Garg, who joined Alnylam in 2014, brings extensive experience from Bristol-Myers Squibb and Millennium Pharmaceuticals. Under his leadership, Alnylam aims to deliver RNAi therapeutics to all major tissues by 2030, building on their track record of multiple drug approvals and positive Phase 3 results. The company sees this integration as crucial for scaling their impact in treating various diseases lacking effective treatments.

Alnylam Pharmaceuticals (ALNY) has received European Commission approval for AMVUTTRA (vutrisiran) to treat ATTR amyloidosis with cardiomyopathy, making it the first RNAi therapeutic approved for this condition in Europe. The approval is based on the HELIOS-B Phase 3 study results, which demonstrated a 28% reduction in composite all-cause mortality and cardiovascular events, and up to 36% reduction in all-cause mortality through 42 months. The drug, administered quarterly, showed significant improvements in functional capacity and quality of life. AMVUTTRA works by reducing disease-causing TTR protein, addressing approximately 100,000 affected patients across Europe. The approval follows recent authorizations in the U.S. and Brazil, with similar safety profiles to placebo in clinical trials.