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Here's Why You Should Add Alnylam (ALNY) Stock to Your Portfolio
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Alnylam Pharmaceuticals (ALNY - Free Report) currently has four approved products in its portfolio — Onpattro (patisiran), Givlaari (givosiran), Oxlumo subcutaneous injection (lumasiran) and Amvuttra (vutrisiran).
The company also records royalty revenues for global sales of Leqvio from its partner, Novartis (NVS - Free Report) . Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam. ALNY is entitled to receive tiered royalties on the global sales of Leqvio from NVS. In the last quarter, the company earned collaboration revenues of $14.9 million from Novartis.
Let’s delve deeper to discuss four reasons why adding Alnylam stock to your portfolio may prove beneficial in 2023.
Shares Outperforming the Industry: Shares of Alnylam have outperformed the industry in the past year, witnessing a rise of 39.5% against the industry’s 8.6% fall. Alnylam sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Image Source: Zacks Investment Research
Amvuttra is Experiencing Increasing Prescription Trends: Amvuttra is approved for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, following which, in September 2022, the European Commission granted marketing authorization to Amvuttra for the same indication in adult patients with stage 1 or 2 polyneuropathy. The drug has been witnessing increasing trends in sales as more patients are shifting from Onpattro therapy to the newly approved drug. As a result, Onpattro sales are declining.
Alnylam is also looking to expand the indication for Amvuttra. A HELIOS-B study on vutrisiran is also currently underway for the treatment of patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Top-line results from the study are expected in early 2024.
Approval of Givlaari & Oxlumo: Givlaariwas approved by the FDA to treat acute hepatic porphyria. The drug has been performing well. Oxlumo is approved in the United States and EU for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels (UOx) in pediatric and adult patients. In October 2022, Oxlumo’s label was further expanded to include treatment of PH1 to lower both UOx and plasma oxalate POx levels in pediatric and adult patients.
Our estimate for Alnylam’s revenues suggests a CAGR of 47.8% over the next three years for Onpattro, Amvuttra, Givlaari and Oxlumo.
Broad & Promising Pipeline: Alnylam is evaluating several pipeline candidates.
The company’s partner, Regeneron (REGN - Free Report) , has initiated phase III studies of cemdisiran and pozelimab combination for treating myasthenia gravis and paroxysmal nocturnal hemoglobinuria. Alnylam, in partnership with Regeneron, is also developing ALN-APP for treating early-onset Alzheimer’s disease (AD).
The companies recently reported updated positive interim data from the Part A of the ongoing phase I study on ALN-APP for the treatment of early-onset AD and cerebral amyloid angiopathy. The interim data readout is focused on assessing safety, tolerability and levels of target engagement biomarkers, sAPPα and sAPPβ. ALNY and REGN have named 10 targets in the central nervous system, in addition to ALN-APP, under its 2019 agreement.
Alnylam is also evaluating zilebesiran, an investigational subcutaneous RNAi therapeutic, in a phase II KARDIA-1 study as a monotherapy for the treatment of hypertension. Top-line data from the study is expected soon. A second phase II KARDIA-2 study is also evaluating the safety and efficacy of zilebesiran in patients with the same indication as the KARDIA-1 study. Enrollment in the KARDIA-II study is expected to be completed soon around the end of 2023.
ALN-HBV02 (also known as VIR-2218), in partnership with Vir Biotechnology, is currently being evaluated in a phase II study in combination with VIR-3434 and/or PEG-IFN-α for the treatment of chronic hepatitis B virus infection. Top-line data from the study is expected in the first half of 2024.
Alnylam is also looking to expand the indication for Onpattro, which was initially approved for hATTR amyloidosis in adults. In December 2022, the company filed a supplemental new drug application with the FDA, seeking approval to expand Onpattro’s label for treating cardiomyopathy of ATTR amyloidosis in adults. A decision is expected on Oct 8, 2023. Label expansion of the drug is likely to boost sales.
The successful development and subsequent approval of all these candidates will be a huge boost for the company.
Despite the positives, there are other key players in the heart disease market, like Bridge Bio (BBIO - Free Report) , who can pose serious competition to Alnylam. Bridge Bio recently reported meeting the primary endpoint in its late-stage study of acoramidis in patients with ATTR-CM with statistical significance. The phase III ATTRibute-CM study is evaluating an oral formulation of acoramidis as a next-generation, highly potent stabilizer of transthyretin.
The primary endpoint of the study was determined through a hierarchical analysis. After 30 months, the study showed an 81% survival rate among patients who received acoramidis compared with 74% among those in the placebo group. In addition, there was a significant relative risk reduction of 50% in the frequency of cardiovascular-related hospitalizations.
Bridge Bio plans to submit the new drug application for acoramidis to the FDA by the end of 2023. BBIO also intends to submit regulatory filings in additional markets by 2024.
However, Alnylam’s deep pipeline is expected to provide the company with an edge over its competitors. Developmental milestones from several studies of investigational candidates are coming up by the end of this year or early 2024. Successful results and potential approval in the future are likely to boost the stock.
Image: Bigstock
Here's Why You Should Add Alnylam (ALNY) Stock to Your Portfolio
Alnylam Pharmaceuticals (ALNY - Free Report) currently has four approved products in its portfolio — Onpattro (patisiran), Givlaari (givosiran), Oxlumo subcutaneous injection (lumasiran) and Amvuttra (vutrisiran).
The company also records royalty revenues for global sales of Leqvio from its partner, Novartis (NVS - Free Report) . Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam. ALNY is entitled to receive tiered royalties on the global sales of Leqvio from NVS. In the last quarter, the company earned collaboration revenues of $14.9 million from Novartis.
Let’s delve deeper to discuss four reasons why adding Alnylam stock to your portfolio may prove beneficial in 2023.
Shares Outperforming the Industry: Shares of Alnylam have outperformed the industry in the past year, witnessing a rise of 39.5% against the industry’s 8.6% fall. Alnylam sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Image Source: Zacks Investment Research
Amvuttra is Experiencing Increasing Prescription Trends: Amvuttra is approved for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, following which, in September 2022, the European Commission granted marketing authorization to Amvuttra for the same indication in adult patients with stage 1 or 2 polyneuropathy. The drug has been witnessing increasing trends in sales as more patients are shifting from Onpattro therapy to the newly approved drug. As a result, Onpattro sales are declining.
Alnylam is also looking to expand the indication for Amvuttra. A HELIOS-B study on vutrisiran is also currently underway for the treatment of patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Top-line results from the study are expected in early 2024.
Approval of Givlaari & Oxlumo: Givlaariwas approved by the FDA to treat acute hepatic porphyria. The drug has been performing well. Oxlumo is approved in the United States and EU for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels (UOx) in pediatric and adult patients. In October 2022, Oxlumo’s label was further expanded to include treatment of PH1 to lower both UOx and plasma oxalate POx levels in pediatric and adult patients.
Our estimate for Alnylam’s revenues suggests a CAGR of 47.8% over the next three years for Onpattro, Amvuttra, Givlaari and Oxlumo.
Broad & Promising Pipeline: Alnylam is evaluating several pipeline candidates.
The company’s partner, Regeneron (REGN - Free Report) , has initiated phase III studies of cemdisiran and pozelimab combination for treating myasthenia gravis and paroxysmal nocturnal hemoglobinuria. Alnylam, in partnership with Regeneron, is also developing ALN-APP for treating early-onset Alzheimer’s disease (AD).
The companies recently reported updated positive interim data from the Part A of the ongoing phase I study on ALN-APP for the treatment of early-onset AD and cerebral amyloid angiopathy. The interim data readout is focused on assessing safety, tolerability and levels of target engagement biomarkers, sAPPα and sAPPβ. ALNY and REGN have named 10 targets in the central nervous system, in addition to ALN-APP, under its 2019 agreement.
Alnylam is also evaluating zilebesiran, an investigational subcutaneous RNAi therapeutic, in a phase II KARDIA-1 study as a monotherapy for the treatment of hypertension. Top-line data from the study is expected soon. A second phase II KARDIA-2 study is also evaluating the safety and efficacy of zilebesiran in patients with the same indication as the KARDIA-1 study. Enrollment in the KARDIA-II study is expected to be completed soon around the end of 2023.
ALN-HBV02 (also known as VIR-2218), in partnership with Vir Biotechnology, is currently being evaluated in a phase II study in combination with VIR-3434 and/or PEG-IFN-α for the treatment of chronic hepatitis B virus infection. Top-line data from the study is expected in the first half of 2024.
Alnylam is also looking to expand the indication for Onpattro, which was initially approved for hATTR amyloidosis in adults. In December 2022, the company filed a supplemental new drug application with the FDA, seeking approval to expand Onpattro’s label for treating cardiomyopathy of ATTR amyloidosis in adults. A decision is expected on Oct 8, 2023. Label expansion of the drug is likely to boost sales.
The successful development and subsequent approval of all these candidates will be a huge boost for the company.
Despite the positives, there are other key players in the heart disease market, like Bridge Bio (BBIO - Free Report) , who can pose serious competition to Alnylam. Bridge Bio recently reported meeting the primary endpoint in its late-stage study of acoramidis in patients with ATTR-CM with statistical significance. The phase III ATTRibute-CM study is evaluating an oral formulation of acoramidis as a next-generation, highly potent stabilizer of transthyretin.
The primary endpoint of the study was determined through a hierarchical analysis. After 30 months, the study showed an 81% survival rate among patients who received acoramidis compared with 74% among those in the placebo group. In addition, there was a significant relative risk reduction of 50% in the frequency of cardiovascular-related hospitalizations.
Bridge Bio plans to submit the new drug application for acoramidis to the FDA by the end of 2023. BBIO also intends to submit regulatory filings in additional markets by 2024.
However, Alnylam’s deep pipeline is expected to provide the company with an edge over its competitors. Developmental milestones from several studies of investigational candidates are coming up by the end of this year or early 2024. Successful results and potential approval in the future are likely to boost the stock.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote