The Medicines Company MDCO announced detailed data from the pivotal phase III ORION-10 study evaluating its PCSK9 inhibitor candidate inclisiran for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD).
Patients treated with twice-a-year dosing of inclisiran 300 mg achieved 58% low-density lipoprotein cholesterol (LDL-C), lowering with time-adjusted reductions in LDL-C levels of 56%, which was over 18 months of treatment in patients with ASCVD.
Full data from the study were presented at the American Heart Association (AHA) scientific sessions held in Philadelphia.
In September 2019, the company announced positive top-line results from the ORION-10 study wherein inclisiran demonstrated favorable safety profile and was well-tolerated. The study met all the primary and secondary efficacy endpoints. Moreover, safety data from the study showed that no treatment-related liver or renal laboratory abnormalities were observed.
Shares of the Medicines Company have skyrocketed 171.6% so far this year compared with the industry’s increase of 2.5%.
Notably, the Medicines Company is developing inclisiran in partnership with Alnylam Pharmaceuticals ALNY.
The Medicines Company successfully completed three pivotal phase III studies, namely ORION-9, ORION-10 and ORION-11 evaluating inclisiran in patients with heterozygous familial hypercholesterolemia (HeFH) and ASCVD.
In September 2019, the company announced detailed data from the ORION-11 study, which showed that twice-a-year administration of inclisiran achieved a placebo-adjusted 54% reduction in LDL-C levels. The study evaluated inclisiran in patients with ASCVD or ASCVD-risk equivalents and elevated LDL-C following treatment with maximum tolerated dose of statin therapy alone or in combination with Merck’s MRK Zetia.
The company plans to file a new drug application seeking approval of inclisiran in the United States during the fourth quarter of 2019 as well as a marketing authorization application in the EU during the first quarter of 2020.
Zacks Rank & Key Pick
The Medicines Company currently has a Zacks Rank #3 (Hold) stock. A better-ranked stock in the biotech sector is Anika Therapeutics Inc. ANIK, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have been revised 16% upward for 2019 and 19.1% for 2020 over the past 60 days. The stock has surged 78.6% so far this year.
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