The Medicines Company (NASDAQ: MDCO) is heading up in the market this morning, and for good reason. The comapny announced positive clinical data, exciting investors whoa re pushing the stock for early gains of more than 7%. Here’s what’s happening:
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MDCO Stock Pops On Clinical Data
In a press release issued early this morning, The Medicines Company provided results from the first pivotal Phase 3 clinical study of inclisirin. In the study, the company was assessing the efficacy, safety, and tolerability of the treatment in the decrease of LDL-cholesteron through twice-yearly dosing.
In the release, MDCO said that the study, known as ORION-11 met all primary and secondary endpoints. Moreover, efficacy was consistent with the positive findings from the Phase 1 and 2 studies of the drug.
The company also said that the treatment proved to be well tolerated and maintained a similar safety profile to that seen in the Phase 1 and Phase 2 studies.
On Monday, September 2, the company will be presenting detailed data from the study during a late-breaking science session at the European Society of Cardiology’s ESC Congress 2019.
In a statement, Mark Timney, CEO at MDCO, had the following to offer:
This is a momentous occasion that further reinforces our confidence in the tremendous potential of inclisiran to fundamentally change the treatment of cardiovascular disease. 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 patients achieve treatment goals and live longer, healthier lives.
The above statement was followed up by Peter Wijingaard, Ph.D., Chief Development Officer at MDCO. Here’s what he had to say:
The Medicines Company thanks the many patients, investigators and their colleagues at the clinical trial sites for their participation in ORION-11. We look forward to presenting detailed study results during the ESC Congress 2019 and also submitting data for publication in a peer-reviewed journal.
Why This News Is Significant
At the end of the day, positive clinical data is just about always a great thing for biotechnology companies. However, the benefit of today’s release goes far beyond positive data.
The trial the data came from is a Pivotal Phase 3 trial. These are the clinical trials that, if positive, lead to New Drug Applications submitted to the FDA and other regulatory submissions around the world.
The Medicines Company’s plans with regard to submissions was outlined in the release. In fact, the company said that the sequential release of Topline Phase 3 readouts for two other studies are expected to come later in the quarter, setting the stage for strong catalysts ahead.
Moreover, MDCO said that it expects to start regulatory submissions in the United States by the fourth quarter of this year and in Europe by the first quarter of next year. So, the drug may receive market approval relatively soon.
This would be substantial. After all, the market for these drugs is expected to grow to be worth more than $22 billion annually in the coming years. That’s a massive indication that represents serious potential for this biotech with just a $3.4 billion market cap.
All in all, today’s news sets the stage for a potential blockbuster treatment to move into regulatory submissions and likely approval!
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