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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 236.4% year to date compared with the industry’s gain of 0.2%. Here we analyze the factors that led to the rally.
Alnylam is a development-stage biopharmaceutical company focused on the development of novel therapeutics based on RNA interference (RNAi), which is being considered a radical technology. This technology is a naturally occurring biological pathway within cells for selectively silencing and regulating the expression of specific genes.
Of late, the company has entered into several collaborations for the development and commercialization of its broad pipeline of RNAi therapeutic candidates across three strategic therapeutic areas (STArs). We are impressed by Alnylam’s strategy of entering into collaborations with other players like Novartis (NVS - Free Report) , Roche (RHHBY - Free Report) , Takeda, Merck and Monsanto for the further development and utilization of its core technology.
Also, Alnylam’s progress on the back of its pipeline candidates this year has been impressive. In fact, Patisiran is one of the most advanced candidates that has progressed successfully so far. The company reported positive data from the phase III APOLLO study on patisiran that met its primary as well as all secondary endpoints. Based on these encouraging results, Alnylam initiated submission of a rolling new drug application (NDA) to the FDA for patisiranand expects to file the first marketing application in the EU in early 2018. The company’s partner Sanofi (SNY - Free Report) expects to make regulatory filings in Japan, Brazil and other countries in the first half of 2018.
Another pipeline candidate of the company, givosiran, is in phase I and is being assessed for the treatment of acute hepatic porphyrias. Recently, the candidate received Breakthrough Therapy designation from the FDA for the same indication.
Another important pipeline candidate is inclisiran (formerly known as PCSK9si or ALN-PCSsc) in phase II ORION studies for hypercholesterolemia. In April 2017, Alnylam and its partner Medicines Company announced that the FDA has approved plans on phase III study design for inclisiran, which is designed to support the submission of a new drug application (NDA). The NDA submission is expected by the end of 2019.
However, in September 2017, Alnylam reported a death event in an open-label extension phase II study on its hemophilia candidate fitusiran. Consequently, the company stopped dosing in all ongoing studies on fitusiran, following the fatal event. However, it will resume dosing after discussion with global regulatory authorities and proper protocol amendments for enhanced patient safety monitoring in place. Alnylam is currently reviewing the risk-benefit profile and developing a risk mitigation strategy for fitusiran.
Successful development and subsequent approval of these candidates are expected to be a huge boost for the company. Specifically, by the end of 2020, Alnylam expects to achieve a company profile with three marketed products, 10 RNAi therapeutic clinical programs including four in late stages of development across its three STArs.
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Why is Alnylam's (ALNY) Stock Up More Than 200% this Year?
Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) have soared 236.4% year to date compared with the industry’s gain of 0.2%. Here we analyze the factors that led to the rally.
Alnylam is a development-stage biopharmaceutical company focused on the development of novel therapeutics based on RNA interference (RNAi), which is being considered a radical technology. This technology is a naturally occurring biological pathway within cells for selectively silencing and regulating the expression of specific genes.
Of late, the company has entered into several collaborations for the development and commercialization of its broad pipeline of RNAi therapeutic candidates across three strategic therapeutic areas (STArs). We are impressed by Alnylam’s strategy of entering into collaborations with other players like Novartis (NVS - Free Report) , Roche (RHHBY - Free Report) , Takeda, Merck and Monsanto for the further development and utilization of its core technology.
Also, Alnylam’s progress on the back of its pipeline candidates this year has been impressive. In fact, Patisiran is one of the most advanced candidates that has progressed successfully so far. The company reported positive data from the phase III APOLLO study on patisiran that met its primary as well as all secondary endpoints. Based on these encouraging results, Alnylam initiated submission of a rolling new drug application (NDA) to the FDA for patisiranand expects to file the first marketing application in the EU in early 2018. The company’s partner Sanofi (SNY - Free Report) expects to make regulatory filings in Japan, Brazil and other countries in the first half of 2018.
Another pipeline candidate of the company, givosiran, is in phase I and is being assessed for the treatment of acute hepatic porphyrias. Recently, the candidate received Breakthrough Therapy designation from the FDA for the same indication.
Another important pipeline candidate is inclisiran (formerly known as PCSK9si or ALN-PCSsc) in phase II ORION studies for hypercholesterolemia. In April 2017, Alnylam and its partner Medicines Company announced that the FDA has approved plans on phase III study design for inclisiran, which is designed to support the submission of a new drug application (NDA). The NDA submission is expected by the end of 2019.
However, in September 2017, Alnylam reported a death event in an open-label extension phase II study on its hemophilia candidate fitusiran. Consequently, the company stopped dosing in all ongoing studies on fitusiran, following the fatal event. However, it will resume dosing after discussion with global regulatory authorities and proper protocol amendments for enhanced patient safety monitoring in place. Alnylam is currently reviewing the risk-benefit profile and developing a risk mitigation strategy for fitusiran.
Successful development and subsequent approval of these candidates are expected to be a huge boost for the company. Specifically, by the end of 2020, Alnylam expects to achieve a company profile with three marketed products, 10 RNAi therapeutic clinical programs including four in late stages of development across its three STArs.
Alnylam carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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