Shares of Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) soared by more than 50% after the company and its partner Sanofi (SNY - Free Report) announced that a pivotal phase III study on its pipeline candidate patisiran met its primary as well as all secondary endpoints.
Alnylam’s shares have outperformed the industry year to date. The stock has been up 204.1% compared with the industry's gain of 16.4% in the same time frame.
Patisiran is an investigational RNAi therapeutic which has been developed to treat patients with hereditary ATTR amyloidosis with polyneuropathy. The phase III APOLLO study demonstrated that at 18 months, the mean change from baseline in the modified neuropathy impairment score (mNIS+7) - the primary endpoint was significantly lower in the patisiran arm as compared with placebo.
Additionally, the study met its key secondary endpoint of improvement in quality of life. The patients who were administered patisiran experienced significant improvement in quality of life compared to placebo. The study also met all its other five secondary endpoints.
APOLLO was the largest randomized study ever completed in this disease. The study also demonstrated the first ever positive results for an RNAi therapeutic. According to Alnylam, hATTR amyloidosis represents a major unmet medical need and affects about 50,000 people worldwide. Thus the potential approval of patisiran will be a huge boost for the people suffering from this often fatal disease.
Based on these encouraging results, Alnylam expects to file its first New Drug Application (NDA) in late 2017 and the first marketing application in the EU in early 2018. Sanofi expects to make regulatory filings in Japan, Brazil and other countries in the first half of 2018. Alnylam also said it would commercialize patisiran in the United States, Canada and Western Europe, while Sanofi would commercialize it in the rest of the world.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #5 (Strong Sell). Better-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion Pharmaceuticals’ earnings per share estimates have moved up from $5.32 to $5.60 for 2017 and from $6.56 to $7.05 for 2018 over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 11.12%. The share price of the company has increased 16.9% year to date.
Regeneron’s earnings per share estimates have increased from $12.84 to $14.99 for 2017 and from $15.32 to $16.64 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 19.3% year to date.
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