The Medicines Company (NASDAQ: MDCO) is running for the top this morning, trading on gains of more than 14% premarket. The gains come after the comapny announced positive data from a late-stage clinical trial in the treatment of high cholesterol late last week. Here’s what’s happening:
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MDCO Rockets On Data
News is breaking surrounding a release of data made by The Medicines Company. The data came from a Phase 3 trial of incliran.
Incliran is an investigational, bi-annual treatment that is being assessed as an option to reduce LDL cholesterol in patients with high LDL-C levels. The drug is the first and only cholseterol-lowering therapy in the siRNA class.
In the update, the company said that the drug not only met its primary and secondary endpoints, MDCO announced a positive safety and tolerability profile.
This Is Exciting
At the end of the day, the data is overwhelmingly exciting for MDCO and its investors. First and foremost, the positive data in a pivotal clinical trial means that the company is likely to submit an application for regulatory approval relatively soon. However, the excitement goes further than that.
The siRNA approach is a new, less intensive approach to the treatment of high LDL-C cholesterol. With this approach, only two treatment deliveries are required on an annual basis. Current options that take the antibody approach to the reduction of LDL-C are daily doses. So, the option that will likely make it to regulatory submission relatively soon could grab the interest of consumers VERY quickly.
Moreover, the high cholesterol drugs market is not a small one by any means. In fact, by 2022, the market is expected to grow to be worth more than $22 billion per year. Considering the less frequent dosing, strong efficacy and safety data from the trial, and the fact that for many patients, the current antibody approach doesn’t work, if approved, MDCO has a strong chance of quickly building Inlcliran into a blockbuster revenue generator.
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