We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Alnylam Rallies 62% in a Year: Can the Stock Maintain This Momentum?
Read MoreHide Full Article
Alnylam Pharmaceuticals (ALNY - Free Report) focuses on developing novel therapeutics based on RNAi technology. The company’s pipeline of experimental RNAi therapeutics is focused across three strategic therapeutic areas — genetic medicines, cardio-metabolic disease and hepatic infectious disease. Alnylam’s marketed portfolio of drugs comprises Amvuttra (vutrisiran), Givlaari (givosiran), Oxlumo (lumasiran) and Onpattro (patisiran).
In the past year, shares of ALNY have surged 62% against the industry’s 7.9% decline. The significant stock price rally has been driven by increasing sales of its marketed drugs, along with encouraging pipeline progress.
Image Source: Zacks Investment Research
Let’s delve deeper to discuss the factors that can fuel further growth of Alnylam stock in 2025.
ALNY’s Portfolio of Marketed Drugs Boosts Revenues
Amvuttra, Alnylam’s lead drug, is approved in the United States and EU for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The drug’s sales contribute significantly to ALNY’s top line. Amvuttra generated sales worth $970.5 million in 2024, up 74% on a year-over-year basis. The encouraging uptake of the drug is driven by new patients starting treatment as well as patient switches from Onpattro. Notably, Onpattro is approved in the United States and EU to treat hATTR amyloidosis in adults.
In 2019, the FDA approved Givlaari for acute hepatic porphyria. In 2020, the FDA approved Oxlumo injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 to lower urinary and plasma oxalate levels in pediatric and adult patients. The combined sales of these two drugs generated $422.9 million for ALNY in 2024, up 29% year over year.
Alnylam also markets a fifth drug, Leqvio (inclisiran), in collaboration with Novartis (NVS - Free Report) to treat hypercholesterolemia in the EU. In the United States, it is approved to reduce low-density lipoprotein cholesterol with two doses per year. Per the agreement, Alnylam has granted Novartis exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for treating hypercholesterolemia and other diseases, including Leqvio. The FDA has approved Leqvio for earlier use in high-risk patients alongside diet and statins. As of January 2025, Leqvio is approved in more than 100 countries, with ongoing late-stage studies for further label expansion.
ALNY’s Pipeline Development Programs Hold Potential
Besides its marketed drug portfolio, Alnylam also has an impressive clinical-stage pipeline. The company is working to expand Amvuttra’s label. In November 2024, the FDA accepted Alnylam’s supplemental new drug application (sNDA) seeking the label expansion of Amvuttra for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on March 23, 2025. Approvals in Japan and the EU are also expected in 2025.
Subject to approval, Alnylam believes that vutrisiran has the potential to become the new standard of care for the treatment of ATTR-CM. This will expand the eligible patient population for the drug, driving substantial growth for the company in the future.
Alnylam and its partner, Regeneron (REGN - Free Report) , are developing cemdisiran in combination with pozelimab in different phase III studies for myasthenia gravis and geographic atrophy and as a monotherapy in a separate phase III study for paroxysmal nocturnal hemoglobinuria. Per the modified agreement with Regeneron, signed in June 2024, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as a monotherapy and in combination with anti-C5 antibodies for complement-mediated indications.
Alnylam, in partnership with Regeneron, was developing another candidate, mivelsiran (formerly ALN-APP), for treating early-onset Alzheimer’s disease (AD) and cerebral amyloid angiopathy (CAA). However, Alnylam gained full global development and commercialization rights to mivelsiran in all indications, as Regeneron opted out of further co-development and co-commercialization of mivelsiran. The company expects to report interim data from part B of the phase I study of mivelsiran for AD in the second half of 2025. It also expects to initiate a phase II study on mivelsiran for AD in the second half of 2025. Additionally, Alnylam initiated dosing in a separate phase II study of the candidate for CAA last year.
Alnylam is also collaborating with Roche (RHHBY - Free Report) to co-develop and co-commercialize zilebesiran to treat hypertension. ALNY has already reported encouraging results from two phase II studies, KARDIA-1 and KARDIA-2, that reaffirmed the effectiveness of zilebesiran and its potential to be a best-in-disease treatment providing transformational benefit in patients with hypertension at high cardiovascular risk.
Alnylam/Roche has also initiated the phase II KARDIA-3 study to evaluate the efficacy of zilebesiran when added to two or more hypertension medications in people with uncontrolled hypertension who are at high cardiovascular risk. Data readout is expected in the second half of 2025. Alnylam and Roche also plan to initiate a phase III cardiovascular outcomes study on zilebesiran in the second half of 2025.
The successful development and commercialization of all these candidates will be a huge boost for the company.
Image: Bigstock
Alnylam Rallies 62% in a Year: Can the Stock Maintain This Momentum?
Alnylam Pharmaceuticals (ALNY - Free Report) focuses on developing novel therapeutics based on RNAi technology. The company’s pipeline of experimental RNAi therapeutics is focused across three strategic therapeutic areas — genetic medicines, cardio-metabolic disease and hepatic infectious disease. Alnylam’s marketed portfolio of drugs comprises Amvuttra (vutrisiran), Givlaari (givosiran), Oxlumo (lumasiran) and Onpattro (patisiran).
In the past year, shares of ALNY have surged 62% against the industry’s 7.9% decline. The significant stock price rally has been driven by increasing sales of its marketed drugs, along with encouraging pipeline progress.
Image Source: Zacks Investment Research
Let’s delve deeper to discuss the factors that can fuel further growth of Alnylam stock in 2025.
ALNY’s Portfolio of Marketed Drugs Boosts Revenues
Amvuttra, Alnylam’s lead drug, is approved in the United States and EU for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The drug’s sales contribute significantly to ALNY’s top line. Amvuttra generated sales worth $970.5 million in 2024, up 74% on a year-over-year basis. The encouraging uptake of the drug is driven by new patients starting treatment as well as patient switches from Onpattro. Notably, Onpattro is approved in the United States and EU to treat hATTR amyloidosis in adults.
In 2019, the FDA approved Givlaari for acute hepatic porphyria. In 2020, the FDA approved Oxlumo injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 to lower urinary and plasma oxalate levels in pediatric and adult patients. The combined sales of these two drugs generated $422.9 million for ALNY in 2024, up 29% year over year.
Alnylam also markets a fifth drug, Leqvio (inclisiran), in collaboration with Novartis (NVS - Free Report) to treat hypercholesterolemia in the EU. In the United States, it is approved to reduce low-density lipoprotein cholesterol with two doses per year. Per the agreement, Alnylam has granted Novartis exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for treating hypercholesterolemia and other diseases, including Leqvio. The FDA has approved Leqvio for earlier use in high-risk patients alongside diet and statins. As of January 2025, Leqvio is approved in more than 100 countries, with ongoing late-stage studies for further label expansion.
ALNY’s Pipeline Development Programs Hold Potential
Besides its marketed drug portfolio, Alnylam also has an impressive clinical-stage pipeline. The company is working to expand Amvuttra’s label. In November 2024, the FDA accepted Alnylam’s supplemental new drug application (sNDA) seeking the label expansion of Amvuttra for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on March 23, 2025. Approvals in Japan and the EU are also expected in 2025.
Subject to approval, Alnylam believes that vutrisiran has the potential to become the new standard of care for the treatment of ATTR-CM. This will expand the eligible patient population for the drug, driving substantial growth for the company in the future.
Alnylam and its partner, Regeneron (REGN - Free Report) , are developing cemdisiran in combination with pozelimab in different phase III studies for myasthenia gravis and geographic atrophy and as a monotherapy in a separate phase III study for paroxysmal nocturnal hemoglobinuria. Per the modified agreement with Regeneron, signed in June 2024, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as a monotherapy and in combination with anti-C5 antibodies for complement-mediated indications.
Alnylam, in partnership with Regeneron, was developing another candidate, mivelsiran (formerly ALN-APP), for treating early-onset Alzheimer’s disease (AD) and cerebral amyloid angiopathy (CAA). However, Alnylam gained full global development and commercialization rights to mivelsiran in all indications, as Regeneron opted out of further co-development and co-commercialization of mivelsiran. The company expects to report interim data from part B of the phase I study of mivelsiran for AD in the second half of 2025. It also expects to initiate a phase II study on mivelsiran for AD in the second half of 2025. Additionally, Alnylam initiated dosing in a separate phase II study of the candidate for CAA last year.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
Alnylam is also collaborating with Roche (RHHBY - Free Report) to co-develop and co-commercialize zilebesiran to treat hypertension. ALNY has already reported encouraging results from two phase II studies, KARDIA-1 and KARDIA-2, that reaffirmed the effectiveness of zilebesiran and its potential to be a best-in-disease treatment providing transformational benefit in patients with hypertension at high cardiovascular risk.
Alnylam/Roche has also initiated the phase II KARDIA-3 study to evaluate the efficacy of zilebesiran when added to two or more hypertension medications in people with uncontrolled hypertension who are at high cardiovascular risk. Data readout is expected in the second half of 2025. Alnylam and Roche also plan to initiate a phase III cardiovascular outcomes study on zilebesiran in the second half of 2025.
The successful development and commercialization of all these candidates will be a huge boost for the company.
ALNY’s Zacks Rank
Alnylam currently carries a Zacks Rank 3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.