The Medicines Company (MDCO - Free Report) announced that Independent Data Monitoring Committee (IDMC) has recommended that the ongoing phase III ORION studies on its late-stage candidate, inclisiran, will continue as designed and conducted, without any modification.
The latest recommendation from the IDMC comes after the regulatory body’s fourth review of the unblinded safety and efficacy data from the ORION studies on the PCSK9 inhibitor, which Medicines Company thinks to have blockbuster potential.
Inclisiran is being evaluated in ORION studies to treat patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL or “bad cholesterol” levels. Medicines Company and Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) are collaborating for the development of inclisiran.
Share of Medicines Company were up 2.9%, following the announcement of the news on Monday. In fact, the stock has rallied 14% so far this year against the industry’s decline of 1.8%.
At the time of IDMC’s review, almost all patients had either received two doses of inclisiran or placebo, while 648 patients received a third dose.
Medicines Company stated that more than 1,899 patient-years of safety data have been assembled in the ORION phase III program to date. The figure represents a five-fold increase over the total patient exposure registered from the phase I/II studies.
Medicines Company plans to report top-line data from the studies in the second half of 2019.
Notably, both the companies earlier said that they plan to submit regulatory filings for inclisiran in the United States and the EU by the end of 2019. However, in the latest press release, Medicines Company did not provide any update in the timeline for regulatory filings for inclisiran.
Zacks Rank & Stocks to Consider
The Medicines Company currently carries a Zacks Rank #3 (Hold).
Two better-ranked stocks in the same sector are Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Athersys, Inc. (ATHX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings estimates have been revised 28.4% upward for 2018 and 6.5% for 2019 over the past 60 days. The stock has skyrocketed 95.8% so far this year.
Athersys’ loss per share estimates narrowed by 12.5% for 2018 and 4.3% for 2019 in the past 60 days. The stock has gained 16.5% year to date.
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