Alnylam Pharmaceuticals, Inc. ( ALNY Quick Quote ALNY - Free Report) have rallied 67.4% in the past three months against the industry’s decrease of 1.5%. Image Source: Zacks Investment Research
The company is making good progress with its portfolio of marketed drugs, Onpattro (patisiran), Givlaari (givosiran), Oxlumo (lumasiran) and the newly approved Amvuttra (vutrisiran).
Alnylam's lead drug, Onpattro, is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. Earlier this month, ALNY announced that the phase III APOLLO-B study evaluating patisiran for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, met its primary endpoint of change from baseline in the 6-Minute Walk Test versus placebo at 12 months. Shares of the company surged following the announcement of the news.
Successful label expansion of Onpattro will help the drug treat a broader patient population which is likely to boost sales in the days ahead.
Givlaari was approved for the treatment of acute hepatic porphyria in the United States in November 2019 and in Europe in March 2020.
Oxlumo injection for subcutaneous use was approved in November 2020 for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
In March 2022, FDA accepted the supplemental new drug application or sNDA for Oxlumo (lumasiran) for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1. A decision from the regulatory body is expected on Oct 6, 2022.
All these drugs have witnessed a strong uptake so far.
In June 2022, the FDA
approved Alnylam’s RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hATTR amyloidosis.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Amvuttra, for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy in July.
Meanwhile, in December 2021, Alnylam’s partner,
Novartis ( NVS Quick Quote NVS - Free Report) received FDA approval for Leqvio (inclisiran) to reduce low-density lipoprotein cholesterol (LDL-C) with two doses a year. Leqvio has also been approved by the European Commission to treat hypercholesterolemia.
Alnylam is entitled to receive tiered royalties on the global sales of Leqvio from NVS.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam.
This apart, Alnylam has a robust portfolio of pipeline candidates which are being developed in various clinical studies for treating various indications.
Though Alnylam is making steady progress with its portfolio of marketed drugs, stiff competition in the target market remains a constant threat. Several other companies are also developing RNAi-based therapeutics. This can induce acute competition for Alnylam in the days ahead. Any regulatory or developmental setbacks will also hurt the stock in the future.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include
Achilles Therapeutics plc ( ACHL Quick Quote ACHL - Free Report) and Atara Biotherapeutics, Inc. ( ATRA Quick Quote ATRA - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.