The Medicines Company MDCO 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 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.
The Medicines Company Price and Consensus
The Medicines Company Price and Consensus | The Medicines Company Quote
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 and Athersys, Inc. ATHX , 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.
Best Electric Car Stock? You'll Never Guess It.
Zacks Research has released a report that may shock many investors. One stock stands out as the best way to invest in the surge to electric cars. And it's not the one you may think!
Much like petroleum 150 years ago, lithium battery power is set to shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge. With battery prices plummeting and charging stations set to multiply, revenues that were already at $31 billion in 2016 are expected to blast to over $67 billion by the end of 2022. See Zacks Best EV Stock Free >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alnylam Pharmaceuticals, Inc. (ALNY): Free Stock Analysis Report Ligand Pharmaceuticals Incorporated (LGND): Free Stock Analysis Report Athersys, Inc. (ATHX): Free Stock Analysis Report The Medicines Company (MDCO): Free Stock Analysis Report To read this article on Zacks.com click here.