We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Alnylam/Sanofi Submit MAA in Europe for RNAi Candidate
Read MoreHide Full Article
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) and partner Sanofi (SNY - Free Report) , announced that they have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lead candidate patisiran. The candidate is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment adults with hereditary ATTR (hATTR) amyloidosis with polyneuropathy.
So far this year, shares of Alnylam have skyrocketed 227.8% compared with the industry’s gain of 3%.
In November, Alnylam announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) granted an accelerated assessment for patisiran. With the accelerated assessment, the company can expect the review timeline to be reduced from the typical 210 days to 150 days once the marketing authorization application (MAA) is filed and validated in the EU.
In December, the company also completed the rolling submission of a New Drug Application (NDA) to the FDA for patisiran. The NDA filing is based on promising results from the APOLLO phase III study that 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.
Meanwhile, Sanofi is preparing to start regulatory filings for patisiran in Japan, Brazil and other countries 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 and will be an important treatment option for the people suffering from this often fatal disease.
Recently, both Alnylam and Sanofi announced that the FDA has lifted clinical hold placed on all ongoing studies of its hemophilia candidate fitusiran. In September, Alnylam stopped dosing in all ongoing studies of fitusiran, a RNA interference (RNAi) therapeutic, following a death event in an open-label extension (OLE) phase II study. The patient was suffering from hemophilia A and died after developing a blood clot inside cerebral venous sinus (thrombotic event).
Alnylam carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space include Sucampo Pharmaceuticals and Corcept Therapeutics Incorporated (CORT - Free Report) . While Sucampo sports a ZacksRank #1 (Strong Buy), Corcept holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have moved up from 31 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 20.3% year to date.
Corcept’s earnings per share estimates have moved up from 78 cents to 88 cents 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 14.32%. The share price of the company has increased 162.4% year to date.
Zacks Editor-in-Chief Goes "All In" on This Stock
Full disclosure, Kevin Matras now has more of his own money in one particular stock than in any other. He believes in its short-term profit potential and also in its prospects to more than double by 2019. Today he reveals and explains his surprising move in a new Special Report.
Image: Bigstock
Alnylam/Sanofi Submit MAA in Europe for RNAi Candidate
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) and partner Sanofi (SNY - Free Report) , announced that they have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lead candidate patisiran. The candidate is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment adults with hereditary ATTR (hATTR) amyloidosis with polyneuropathy.
So far this year, shares of Alnylam have skyrocketed 227.8% compared with the industry’s gain of 3%.
In November, Alnylam announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) granted an accelerated assessment for patisiran. With the accelerated assessment, the company can expect the review timeline to be reduced from the typical 210 days to 150 days once the marketing authorization application (MAA) is filed and validated in the EU.
In December, the company also completed the rolling submission of a New Drug Application (NDA) to the FDA for patisiran. The NDA filing is based on promising results from the APOLLO phase III study that 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.
Meanwhile, Sanofi is preparing to start regulatory filings for patisiran in Japan, Brazil and other countries 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 and will be an important treatment option for the people suffering from this often fatal disease.
Recently, both Alnylam and Sanofi announced that the FDA has lifted clinical hold placed on all ongoing studies of its hemophilia candidate fitusiran. In September, Alnylam stopped dosing in all ongoing studies of fitusiran, a RNA interference (RNAi) therapeutic, following a death event in an open-label extension (OLE) phase II study. The patient was suffering from hemophilia A and died after developing a blood clot inside cerebral venous sinus (thrombotic event).
Alnylam Pharmaceuticals, Inc. Price
Alnylam Pharmaceuticals, Inc. Price | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Alnylam carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space include Sucampo Pharmaceuticals and Corcept Therapeutics Incorporated (CORT - Free Report) . While Sucampo sports a ZacksRank #1 (Strong Buy), Corcept holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have moved up from 31 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 20.3% year to date.
Corcept’s earnings per share estimates have moved up from 78 cents to 88 cents 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 14.32%. The share price of the company has increased 162.4% year to date.
Zacks Editor-in-Chief Goes "All In" on This Stock
Full disclosure, Kevin Matras now has more of his own money in one particular stock than in any other. He believes in its short-term profit potential and also in its prospects to more than double by 2019. Today he reveals and explains his surprising move in a new Special Report.
Download it free >>