We issued an updated research report on Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) on May 23, 2017.
Alnylam’s shares are up 86.5% year to date, comparing favorably with an increase of 0.2% witnessed by the Zacks classified Medical - Biomedical and Genetics industry.
Alnylam Pharmaceuticals Inc. is a development-stage biopharmaceutical company focused on the development of novel therapeutics based on RNA interference (RNAi). The company’s RNAi technology has allowed it to ink collaborations with leading pharmaceutical and life sciences companies like Novartis (NVS - Free Report) , Roche (RHHBY - Free Report) , Monsanto and Sanofi (SNY - Free Report) . These deals not only provide it with funds but also take its RNAi technology outside the core focus area.
Alnylam’s progress with its pipeline candidates 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 ATTR-PN patients. Top-line data from the study are expected in mid 2017 and additional results in late 2017. Alnylam plans to submit regulatory application for patisiran both in the U.S. and the EU by 2017 end.
The company is also evaluating several other candidates. Interesting ones include ALN-CC5 (phase I/II; complement-mediated diseases), fitusiran (phase I/II; hemophilia and rare bleeding disorders) and givosiran (phase I – acute hepatic porphyrias). Moreover, the company is evaluating inclisiran in partnership with The Medicines Company in phase II ORION studies for hypercholesterolemia. The company is also assessing ALN-HBV (phase I/II – HBV infection). Successful development and subsequent approval of these candidates will be a huge boost for the company.
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.
Importantly, Alnylam plans to move three candidates- fitusiran, givosiran and inclisiran to phase III development this year, Alnylam. Alnylam announced last month 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) by the end of 2019.
Alnylam expects to achieve the profile of three marketed products by the end of 2020.
However, although Alnylam has a broad and promising pipeline, these candidates still have a long way to go before hitting the market. Currently, the company depends heavily on its late-stage candidate – patisiran for growth. With so much depending on the successful development and approval of the candidate, any kind of development or regulatory setback could pull down the stock significantly.
Alnylam currently holds a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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