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Alnylam RNAi Drug Gets Accelerated Assessment Grant From EMA

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has granted an accelerated assessment for patisiran.

Patisiran is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis.

So far this year, shares of Alnylam have skyrocketed 244.8% compared with the industry’s gain of 1.5%.

 

 

With the accelerated assessment, Alnylam can expect the review timeline to be reduced from the typical 210 days to 150 once the marketing authorization application (MAA) is filed and validated in the EU. We note that the accelerated assessment was granted partly because of promising results from the APOLLO phase III study, which met its primary as well as all secondary endpoints. The patients who were administered patisiran experienced significant improvement in quality of life compared to placebo. In fact, APOLLO was the largest randomized study ever completed in this disease. The study also demonstrated the first ever positive results for an RNAi therapeutic.

Alnylam intends to file a New Drug Application for patisiran in the United States by the end of 2017, where Fast Track Designation has been granted.

Meanwhile, Alnylam’s partner Sanofi (SNY - Free Report) is preparing for regulatory filings for patisiran in Japan, Brazil and other countries, beginning in the first half of 2018. Once it gets the required regulatory approvals, Alnylam will commercialize patisiran in the United States, Canada and Western Europe with Sanofi commercializing the product in the rest of the world.

Going forward, the potential approval of patisiran is likely to be a huge boost for the people suffering from this often fatal disease. The potential approval should also boost the revenues of the company.

Alnylam Pharmaceuticals, Inc. Price

Zacks Rank & Stocks to Consider

Alnylam carries a Zacks Rank #3 (Hold).Some better-ranked health care stocks in the same space include Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Corcept Therapeutics Incorporated (CORT - Free Report) carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ligand’s earnings per share estimates have moved up $3.68 to $3.70 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 8.22%. The share price of the company has increased 40.5% year to date.

Corcept’searnings per share estimates have moved up from 45 cents to 48 cents for 2017 and from 77 cents to 80 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 14.32%. The share price of the company has increased 144.5% year to date.

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