Results from a Phase 3 clinical trial, ORION-9, evaluating the effect of The Medicines Company's (MDCO +2.3%) inclisiran on reducing "bad" cholesterol (LDL-C) in patients with familial hypercholesterolemia (FH), an inherited condition characterized by abnormally high levels of cholesterol in the blood, showed a treatment benefit. The data were presented at the American Heart Association Scientific Sessions in Philadelphia.
The study met the primary endpoints of percent change in LDL-C from baseline to day 510 (50% reduction) versus placebo and time-averaged percent change (45% reduction) in LDL-C after day 90 up to day 510 versus control. Both values were statistically significant.
No new safety signals were observed.
The results will be submitted for presentation in a peer-reviewed medical journal. The company expects to file a U.S. marketing application this quarter and one in Europe next quarter.
The company will host a conference call today at 12 noon ET to discuss the results from ORION-9 and ORION-10.
In other news, there are also rumblings this morning that Novartis (NYSE:NVS) may be circling.
As always, use protective stops and trade with caution.
Good luck to all!
Congrats to all who participated!