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Why is Alnylam's (ALNY) Stock Up More Than 200% This Year?
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Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) have soared 228.1% year to date, massively outperforming the 2.5% increase registered by the industry. Here we analyze the factors that led to the rally.
Alnylam has been in the news for the past few months based on impressive progress of its pipeline candidates. The company is making fast progress toward its goal of achieving the profile of three marketed products by the end of 2020.
Alnylam completed the rolling submission of a new drug application (NDA) to the FDA for its lead candidate, patisiran last week. Patisiran is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis. In November, this lead candidate was also granted Breakthrough Therapy Designation by the FDA.
Alnylam has also requested a priority review of application for patisiran, which if granted, might result in a six-month review process.
Further, this week the company along with its partner Sanofi (SNY - Free Report) submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for patisiran. The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) also granted an accelerated assessment for this lead candidate. With the accelerated assessment, the company can expect the review timeline to be reduced from the typical 210 days to 150 days once the marketing authorization application is filed and validated in the EU.
The potential approval of patisiran is likely to be a huge boost for Alnylam and will be an important treatment option for the people suffering from this often fatal disease.
This week, Alnylam along with Sanofi also announced that the FDA has lifted clinical hold placed on all ongoing studies of its hemophilia candidate, fitusiran. In September, Alnylam stopped dosing in all ongoing studies of fitusiran, a RNAi therapeutic, following a death event in an open-label extension (OLE) phase II study. The patient was suffering from hemophilia A and died after developing a blood clot inside cerebral venous sinus (thrombotic event).
The company along with partner The Medicine Company is also evaluating inclisiran for hypercholesterolemia and initiated phase III studies for the same. The study is designed to support the submission of a new drug application (NDA), which is expected by the end of 2019. Alnylam also initiated phase III studies for givosiran for the treatment of acute hepatic porphyrias.
Alnylam has entered into several collaborations for the development and commercialization of its broad pipeline of RNAi therapeutic candidates across three STArs. We are impressed with the company’s strategy of entering into collaborations with other players like Ionis, Novartis (NVS - Free Report) , Roche, Takeda, Merck and Monsanto for the further development and utilization of its core technology.
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Image: Bigstock
Why is Alnylam's (ALNY) Stock Up More Than 200% This Year?
Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) have soared 228.1% year to date, massively outperforming the 2.5% increase registered by the industry. Here we analyze the factors that led to the rally.
Alnylam has been in the news for the past few months based on impressive progress of its pipeline candidates. The company is making fast progress toward its goal of achieving the profile of three marketed products by the end of 2020.
Alnylam completed the rolling submission of a new drug application (NDA) to the FDA for its lead candidate, patisiran last week. Patisiran is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis. In November, this lead candidate was also granted Breakthrough Therapy Designation by the FDA.
Alnylam has also requested a priority review of application for patisiran, which if granted, might result in a six-month review process.
Further, this week the company along with its partner Sanofi (SNY - Free Report) submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for patisiran. The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) also granted an accelerated assessment for this lead candidate. With the accelerated assessment, the company can expect the review timeline to be reduced from the typical 210 days to 150 days once the marketing authorization application is filed and validated in the EU.
The potential approval of patisiran is likely to be a huge boost for Alnylam and will be an important treatment option for the people suffering from this often fatal disease.
This week, Alnylam along with Sanofi also announced that the FDA has lifted clinical hold placed on all ongoing studies of its hemophilia candidate, fitusiran. In September, Alnylam stopped dosing in all ongoing studies of fitusiran, a RNAi therapeutic, following a death event in an open-label extension (OLE) phase II study. The patient was suffering from hemophilia A and died after developing a blood clot inside cerebral venous sinus (thrombotic event).
The company along with partner The Medicine Company is also evaluating inclisiran for hypercholesterolemia and initiated phase III studies for the same. The study is designed to support the submission of a new drug application (NDA), which is expected by the end of 2019. Alnylam also initiated phase III studies for givosiran for the treatment of acute hepatic porphyrias.
Alnylam has entered into several collaborations for the development and commercialization of its broad pipeline of RNAi therapeutic candidates across three STArs. We are impressed with the company’s strategy of entering into collaborations with other players like Ionis, Novartis (NVS - Free Report) , Roche, Takeda, Merck and Monsanto for the further development and utilization of its core technology.
Zacks Rank
Alnylam carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>