Medicines Company Shares Reach 2-Year High Amid Positive Inclisiran Data

The Medicines Company MDCO shares have been on a roll. After picking up some momentum Aug 21, the stock rallied strongly Aug. 26 after the company reported top-line results from the ORION-11 study.

The stock continued to rally ahead of the presentation of the detailed results of the study as a late-breaking science session at the European Society of Cardiology 2019 Congress on Monday, Sept. 2 in Paris. 

The presentation apparently didn't disappoint investors, as evidenced by the continued strong upward move by the stock Tuesday. 

Strong Efficacy, Excellent Safety Profile

Medicines Co. said in a Monday press release that results from the first pivotal Phase 3 study of inclisiran, dubbed ORION-11, showed that a twice-yearly dosing with inclisiran sodium 300 mg met all primary and secondary efficacy endpoints.

Inclisiran achieved placebo-adjusted low density lipid-cholesterol, or LDL-C, reductions of more than 54% at day 510 and also demonstrated time-adjusted placebo-adjusted LDL-C reductions of 50% from days 90 through 540.

Medicines Co. said the overall adverse event profiles of the placebo- and inclisiran-treated groups were similar.

Why It's Important

Inclisiran is a small interfering RNA, or siRNA, therapy that has the potential to lower LDL-C by preventing the production of a protein, proprotein convertase subtilisin/kexin type 9, or PCSK9, in the liver.

"The exceptional data from ORION-11 show that inclisiran delivers durable and potent LDL-C reductions through twice-yearly dosing that we believe can address adherence challenges in a way that no other currently used LDL-C lowering medicine can," Medicines Co. CEO Mark Timney said in a statement. 

What's Next

Medicines Co. said it will submit the ORION-11 data to a peer-reviewed medical journal.

It expects to release top-line Phase 3 data readouts for the ORION-9 and ORION-10 studies later in the third quarter in advance of anticipated regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.

Patients who have completed the ORION-9, ORION-10 and ORION-11 Phase 3 studies are enrolling into the ORION-8 study, an open-label, long-term extension study in which they will receive inclisiran for three years to evaluate the efficacy, safety and tolerability of long-term dosing of inclisiran.

Medicines Co. shares were advancing 4.49% to $43.84 at the time of publication Tuesday. 

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