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Morning Movers in Biotech: Clovis Oncology, Inc., Exact Sciences Corporation, GlaxoSmithKline PLC, and Mylan, Inc.

By George Budwell – Mar 27, 2014 at 3:00AM

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Today's top stories in health care and biotech.

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

Let's take a look at the top stories in biotech and health care this morning -- keep an eye out for Clovis Oncology (CLVS -8.06%), Exact Sciences (EXAS 0.81%), GlaxoSmithKline (GSK 1.92%) and Mylan (MYL)

Clovis gives update on early stage lung cancer drug
Shares of Clovis Oncology moved higher by 4.9% yesterday in anticipation of the company's clinical update for CO-1686 and are up 7% in premarket this morning. For those new to this story, CO-1686 is an experimental treatment for non-small cell lung cancer, or NSCLC, in patients with initial activating EGFR mutations and the dominant resistance mutation T790M. According to the company's press release, an interim analysis indicated that 64% of patients receiving CO-1686 thus far have shown an objective response and 91% have experienced stable disease. On the safety side, Clovis reported that only one patient has discontinued treatment because of an adverse event. These data are being presented at the 4th European Lung Cancer Conference in Geneva, and Clovis will also host a conference call this morning to discuss the trial. 

What's important to keep in mind is that this is an early stage study, and NSCLC is a particularly difficult disease to treat. So, while this update shows that CO-1686 is making progress, the drug has a long way to go development-wise.

Shares of Exact Sciences halted ahead of Advisory Committee vote
The U.S. Food and Drug Administration's, or FDA, Molecular and Clinical Genetics Panel will meet at 8 a.m. this morning to discuss Exact Sciences' premarket approval application, or PMA, for its stool-based colorectal cancer diagnostic test, Cologuard. Nasdaq halted trading of the company's shares ahead of this meeting.

Although Cologuard is facing the strictest review type, i.e. Class III, the previously released briefing documents suggest that the FDA may believe this cancer diagnostic met its primary objectives in clinical testing. As such, I am optimistic about Cologuard's chances for approval today. Given that Cologuard is projected to see peak sales in the $1 to $2 billion range and Exact Sciences currently has a market cap slightly under a billion, you might want to keep close tabs on this molecular diagnostic company going forward. 

Mylan wins lawsuit against GlaxoSmithKline over antidepressant
Mylan might be in for a good day after announcing that a jury awarded the company $106.7 million in damages from a lawsuit against GlaxoSmithKline over a contract dispute regarding Paroxetine Hydrochloride Extended-release (ER) Tablets--more commonly known as the antidepressant Paxil. Mylan's management stated in a press release that they intend to "seek additional relief to further protect its rights." Shares of both GlaxoSmithKline and Mylan have yet to react to this news in premarket trading. My view is that the amount of this award may not have much impact to either of these multibillion dollar market cap companies, making this win more of a moral victory for Mylan than anything else.

George Budwell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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