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Alnylam (ALNY) Gets FDA Nod for First-Ever RNAi Therapeutic
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the FDA has approved Onpattro (patisiran) lipid complex injection- a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication.
The FDA approval of Onpattro was based on the results from the APOLLO study that met its primary as well as all secondary endpoints.The results showed that Onpattro improved polyneuropathy and other symptoms compared to placebo. APOLLO was the largest randomized study ever completed in this disease. The study also demonstrated the first-ever positive results for an RNAi therapeutic.
hATTR amyloidosis is a rare, inherited, rapidly progressive and life-threatening disease and the approval of Onpattro marks the arrival of a first-of-its kind treatment option for a rare and devastating condition with limited treatment options. The approval also represents an entirely new approach to treating patients with polyneuropathy in hATTR amyloidosis.
Alnylam submitted a rolling new drug application (NDA) to the FDA in November 2017. Onpattrowas reviewed by the FDA under Priority Review and had previously been granted Breakthrough Therapy and Orphan Drug Designations. On Jul 27, patisiran received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy under accelerated assessment by the European Medicines Agency.
Onpattro is the first approved drug in the portfolio of Alnylam and thus will be a huge boost for the company and the drug will be an important treatment option for the people suffering from this often fatal disease.
So far this year, shares of Alnylam declined 27% compared with the industry’s fall of 5.3%.
Alnylam had a partnership with Sanofi (SNY - Free Report) for Onpattro. However, the agreement was amended in January 2018 and per the amended agreement, Alnylam will fund all development and commercialization costs for Onpattro. Sanofi intends to substantially complete the transition of its Onpattro activities in regions outside the United States, Canada, and Western Europe, consistent with the original scope of its license rights to Onpattro.
Alnylam is also developing other candidate. The company along with its partner The Medicine Company is evaluating inclisiran in phase III ORION studies for hypercholesterolemia. The company is also conducting fitusiran's ATLAS phase III study for the treatment of patients with hemophilia A or B with and without inhibitors. The company expects phase III readouts for fitusiran and inclisiran in 2019, leading to potential approvals in 2020.
Gilead’s earnings per share estimates have increased from $6.12 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 7.2% so far this year.
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Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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Alnylam (ALNY) Gets FDA Nod for First-Ever RNAi Therapeutic
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the FDA has approved Onpattro (patisiran) lipid complex injection- a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication.
The FDA approval of Onpattro was based on the results from the APOLLO study that met its primary as well as all secondary endpoints.The results showed that Onpattro improved polyneuropathy and other symptoms compared to placebo. APOLLO was the largest randomized study ever completed in this disease. The study also demonstrated the first-ever positive results for an RNAi therapeutic.
hATTR amyloidosis is a rare, inherited, rapidly progressive and life-threatening disease and the approval of Onpattro marks the arrival of a first-of-its kind treatment option for a rare and devastating condition with limited treatment options. The approval also represents an entirely new approach to treating patients with polyneuropathy in hATTR amyloidosis.
Alnylam submitted a rolling new drug application (NDA) to the FDA in November 2017. Onpattrowas reviewed by the FDA under Priority Review and had previously been granted Breakthrough Therapy and Orphan Drug Designations. On Jul 27, patisiran received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy under accelerated assessment by the European Medicines Agency.
Onpattro is the first approved drug in the portfolio of Alnylam and thus will be a huge boost for the company and the drug will be an important treatment option for the people suffering from this often fatal disease.
So far this year, shares of Alnylam declined 27% compared with the industry’s fall of 5.3%.
Alnylam had a partnership with Sanofi (SNY - Free Report) for Onpattro. However, the agreement was amended in January 2018 and per the amended agreement, Alnylam will fund all development and commercialization costs for Onpattro. Sanofi intends to substantially complete the transition of its Onpattro activities in regions outside the United States, Canada, and Western Europe, consistent with the original scope of its license rights to Onpattro.
Alnylam is also developing other candidate. The company along with its partner The Medicine Company is evaluating inclisiran in phase III ORION studies for hypercholesterolemia. The company is also conducting fitusiran's ATLAS phase III study for the treatment of patients with hemophilia A or B with and without inhibitors. The company expects phase III readouts for fitusiran and inclisiran in 2019, leading to potential approvals in 2020.
Alnylam Pharmaceuticals, Inc. Price
Alnylam Pharmaceuticals, Inc. Price | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Alnylam has a Zacks Rank #3 (Hold).
A better-ranked stock from the same space worth considering is Gilead Sciences Inc. (GILD - Free Report) carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.12 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 7.2% so far this year.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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