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Why is Alnylam's (ALNY) Stock Close to 100% this Year?
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Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) soared 99.8% this year so far massively outperforming the 3.1% increase registered by the Zacks classified Biomed/Genetics industry during this period. Here we analyze the factors that led to the rally.
Alnylam Pharmaceuticals Inc. 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.
Alnylam 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 also 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.
Alnylam’s progress with its pipeline candidates this year has been impressive. Patisiran, one of the most advanced candidates, has progressed successfully so far. Alnylam is currently evaluating patisiran in the phase III APOLLO study in familial amyloid polyneuropathy (FAP) patients. Top-line data from the study and additional results are expected in 2017. Alnylam plans to submit regulatory application for patisiran both in the U.S. and the EU by 2017 end, if the data are positive.
Importantly, last month -Ionis Pharmaceuticals (IONS - Free Report) announced positive results from a late stage study on its pipeline candidate inotersen also being evaluated for FAP. However, some safety concerns were observed in the study which sent shares of Ionis crashing down.The investor community believes that this puts Alnylam’s patisarin in a favorable position as the drug has shown better safety profile It is believed that patisarin may capture a greater share of the FAP market if approved and marketed successfully.
Another pipeline candidate of the company, givosiran is in phase I and is being assessed for the treatment of acute hepatic porphyrias. The candidate recently received Breakthrough Therapy designation from the FDA for the same indication. The news also pushed up the shares of the company.
Another important pipeline candidate is inclisiran (formerly known as PCSK9si or ALN-PCSsc) in phase II ORION studies for hypercholesterolemia. Alnylam and its partner Medicines Company announced in Apr 2017 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. The company’s fitusiran is in phase I/II for the treatment of hemophilia and rare bleeding disorders. The company plans to advance fitusiran, givosiran and inclisiran into phase III development stage in 2017, which is quite an aggressive goal.
Successful development and subsequent approval of these candidates will 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.
In mid-May the company announced public offering of 5,000,000 shares of its common stock which further pushed the price of the company.
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Why is Alnylam's (ALNY) Stock Close to 100% this Year?
Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) soared 99.8% this year so far massively outperforming the 3.1% increase registered by the Zacks classified Biomed/Genetics industry during this period. Here we analyze the factors that led to the rally.
Alnylam Pharmaceuticals Inc. 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.
Alnylam 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 also 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.
Alnylam’s progress with its pipeline candidates this year has been impressive. Patisiran, one of the most advanced candidates, has progressed successfully so far. Alnylam is currently evaluating patisiran in the phase III APOLLO study in familial amyloid polyneuropathy (FAP) patients. Top-line data from the study and additional results are expected in 2017. Alnylam plans to submit regulatory application for patisiran both in the U.S. and the EU by 2017 end, if the data are positive.
Importantly, last month -Ionis Pharmaceuticals (IONS - Free Report) announced positive results from a late stage study on its pipeline candidate inotersen also being evaluated for FAP. However, some safety concerns were observed in the study which sent shares of Ionis crashing down.The investor community believes that this puts Alnylam’s patisarin in a favorable position as the drug has shown better safety profile It is believed that patisarin may capture a greater share of the FAP market if approved and marketed successfully.
Another pipeline candidate of the company, givosiran is in phase I and is being assessed for the treatment of acute hepatic porphyrias. The candidate recently received Breakthrough Therapy designation from the FDA for the same indication. The news also pushed up the shares of the company.
Another important pipeline candidate is inclisiran (formerly known as PCSK9si or ALN-PCSsc) in phase II ORION studies for hypercholesterolemia. Alnylam and its partner Medicines Company announced in Apr 2017 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. The company’s fitusiran is in phase I/II for the treatment of hemophilia and rare bleeding disorders. The company plans to advance fitusiran, givosiran and inclisiran into phase III development stage in 2017, which is quite an aggressive goal.
Successful development and subsequent approval of these candidates will 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.
In mid-May the company announced public offering of 5,000,000 shares of its common stock which further pushed the price of the company.
Alnylam carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. Price and Consensus | Alnylam Pharmaceuticals, Inc. Quote
3 Stocks to Ride a 588% Revenue Explosion
At Zacks, we're mostly focused on short-term profit cycles, but the hottest of all technology mega-trends is starting to take hold... By last year, it was already generating $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for those who make the right trades early. See Zacks' Top 3 Stocks to Ride This Space >>