Shares of Medicines Co. (MDCO) shot up by about 10% Monday, before settling down, after the biopharmaceutical company reported positive Phase 3 trial results for its cholesterol-lowering therapy inclisiran.
The stock was up 10.45% to $38.69 at last check Monday.
The Parsippany, N.J.-based company said the results of the trial evaluate the "efficacy, safety, and tolerability" of inclisiran to decrease low-density lipoprotein cholesterol (also known as LDL-C) through twice-yearly dosing. The trial confirmed the safety profile was "at least as favorable" as in earlier studies.
"This is a momentous occasion that further reinforces our confidence in the tremendous potential of inclisiran to fundamentally change the treatment of cardiovascular disease," CEO Mark Timney said in a statement. "I am proud of our clinical development team's commitment to expeditiously advance this first-in-class investigational therapy that could help millions of ASCVD [atherosclerotic cardiovascular disease] patients achieve treatment goals and live longer, healthier lives."
Medicines Co. shares have more than doubled from their 52-week low of $16.69 on Dec. 21. The stock was down about 10% from year ago based on Friday's close.
The company said it plans to release full results at the European Society of Cardiology meeting in Paris on Sept. 2
J.P. Morgan analyst Jessica Fye called the news "encouraging" in a note to clients on Monday.
"We had a chance to catch up with MDCO who reiterated that the 'at least as favorable' language around safety applies to every aspect of the safety profile which we interpret as covering areas that have been of particular focus for investors," said Fye, who has an overweight rating on the stock and $39 price target.
"Overall, we came away from this encouraging top-line release with even stronger conviction in the safety profile of inclisiran and believe this coupled with rational pricing and greatly improved dosing convenience/compliance will lead to a substantial market opportunity. Reiterate Overweight."
Cowen analyst Chris Shibutani described the news as "an important, further incremental de-risking event" for the company and noted the trials are the first of three "pivotal trials" expected to be reported this quarter.
"In terms of safety, we continue to expect LDL-C lowering of approximately 50%, based on previous data and MDCO guidance, and a clean safety profile, given the numerous Independent Data Monitoring Committee reviews that have allowed the Phase 3 pivotal program (ORION-11, ORION-9, and ORION-10 trials) to continue as planned," Shibutani wrote in a note on Monday. He has an outperform rating on the stock and $46 price target.
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