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The Medicines Co LDL-Lowering Drug Positive in Phase II
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The Medicines Company announced positive top-line results from a Day 180 interim analysis of the ongoing ORION-1 phase II study on its pipeline candidate, Inclisiran (formerly PCSK9si), for the treatment of hypercholesterolemia.
The Medicines Company is developing Inclisiran under a collaboration agreement with Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) , which was inked in early 2013. The Medicines Company is solely responsible for the development and commercialization of the candidate.
The Medicines Company’s three-month share price movement shows that the stock has outperformed the Zacks classified Medical - Biomedical and Genetics industry. Specifically, the company lost 1.7%, while the industry lost 3.7%.
ORION-1 is a placebo-controlled, double-blinded, randomized, dose-finding phase II study. It compares and evaluates the effect of various doses of single or multiple subcutaneous injections of Inclisiran. The study was conducted in a total of 501 patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (hypercholesterolemia).
Interim data demonstrated that Inclisiran led to a significant and durable reduction of LDL (low-density lipoprotein) cholesterol up to Day 210. Inclisiran was well tolerated throughout the study, with infrequent and mild or moderate injection site reactions. Data from the study will be presented at the annual meeting of the American College of Cardiology, scheduled to be held in Mar 2017.
The company expects to move Inclisiran into phase III development (OROPN-4 study) after discussions with regulatory authorities.
Meanwhile, the company announced the initiation of ORION-2 for evaluating the efficacy, safety and tolerability of Inclisiran in patients with homozygous familial hypercholesterolemia (HoFH). Moreover, the company commenced enrollment of ORION-1 patients in the phase II ORION-3 extension study, which will evaluate the efficacy, safety and tolerability of long-term dosing of Inclisiran.
Note that, apart from Inclisiran, The Medicines Company has several interesting pipeline candidates targeting key focus areas. Three of these candidates – MDCO-216 (atherosclerotic plaque burden), ABP-700 (general anesthesia for surgical care) and Carbavance (treatment of hospitalized patients with serious gram-negative bacterial infections) – have blockbuster potential.
The Medicines Company currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector include Orexigen Therapeutics, Inc. and Arbutus Biopharma Corporation (ABUS - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Orexigen’s loss estimates widened from $8.93 to $8.17 for 2016 and from $5.19 to $2.17 for 2017 over the last 60 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 0.66%. Its share price increased 12.7% in the past three months.
Arbutus Biopharma’s loss estimates widened from $1.76 to $1.71 for 2016 and from $1.53 to $1.52 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 59.31%.
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The Medicines Co LDL-Lowering Drug Positive in Phase II
The Medicines Company announced positive top-line results from a Day 180 interim analysis of the ongoing ORION-1 phase II study on its pipeline candidate, Inclisiran (formerly PCSK9si), for the treatment of hypercholesterolemia.
The Medicines Company is developing Inclisiran under a collaboration agreement with Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) , which was inked in early 2013. The Medicines Company is solely responsible for the development and commercialization of the candidate.
The Medicines Company’s three-month share price movement shows that the stock has outperformed the Zacks classified Medical - Biomedical and Genetics industry. Specifically, the company lost 1.7%, while the industry lost 3.7%.
ORION-1 is a placebo-controlled, double-blinded, randomized, dose-finding phase II study. It compares and evaluates the effect of various doses of single or multiple subcutaneous injections of Inclisiran. The study was conducted in a total of 501 patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (hypercholesterolemia).
Interim data demonstrated that Inclisiran led to a significant and durable reduction of LDL (low-density lipoprotein) cholesterol up to Day 210. Inclisiran was well tolerated throughout the study, with infrequent and mild or moderate injection site reactions. Data from the study will be presented at the annual meeting of the American College of Cardiology, scheduled to be held in Mar 2017.
The company expects to move Inclisiran into phase III development (OROPN-4 study) after discussions with regulatory authorities.
Meanwhile, the company announced the initiation of ORION-2 for evaluating the efficacy, safety and tolerability of Inclisiran in patients with homozygous familial hypercholesterolemia (HoFH). Moreover, the company commenced enrollment of ORION-1 patients in the phase II ORION-3 extension study, which will evaluate the efficacy, safety and tolerability of long-term dosing of Inclisiran.
Note that, apart from Inclisiran, The Medicines Company has several interesting pipeline candidates targeting key focus areas. Three of these candidates – MDCO-216 (atherosclerotic plaque burden), ABP-700 (general anesthesia for surgical care) and Carbavance (treatment of hospitalized patients with serious gram-negative bacterial infections) – have blockbuster potential.
The Medicines Company Price
The Medicines Company Price | The Medicines Company Quote
Zacks Rank & Other Key Picks
The Medicines Company currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector include Orexigen Therapeutics, Inc. and Arbutus Biopharma Corporation (ABUS - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Orexigen’s loss estimates widened from $8.93 to $8.17 for 2016 and from $5.19 to $2.17 for 2017 over the last 60 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 0.66%. Its share price increased 12.7% in the past three months.
Arbutus Biopharma’s loss estimates widened from $1.76 to $1.71 for 2016 and from $1.53 to $1.52 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 59.31%.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>