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

Today's top stories in health care and biotech.

Mar 27, 2014 at 9:00AM

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 (NASDAQ:CLVS), Exact Sciences (NASDAQ:EXAS), GlaxoSmithKline (NYSE:GSK) and Mylan (NASDAQ: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.

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4 in 5 Americans Are Ignoring Buffett's Warning

Don't be one of them.

Jun 12, 2015 at 5:01PM

Admitting fear is difficult.

So you can imagine how shocked I was to find out Warren Buffett recently told a select number of investors about the cutting-edge technology that's keeping him awake at night.

This past May, The Motley Fool sent 8 of its best stock analysts to Omaha, Nebraska to attend the Berkshire Hathaway annual shareholder meeting. CEO Warren Buffett and Vice Chairman Charlie Munger fielded questions for nearly 6 hours.
The catch was: Attendees weren't allowed to record any of it. No audio. No video. 

Our team of analysts wrote down every single word Buffett and Munger uttered. Over 16,000 words. But only two words stood out to me as I read the detailed transcript of the event: "Real threat."

That's how Buffett responded when asked about this emerging market that is already expected to be worth more than $2 trillion in the U.S. alone. Google has already put some of its best engineers behind the technology powering this trend. 

The amazing thing is, while Buffett may be nervous, the rest of us can invest in this new industry BEFORE the old money realizes what hit them.

KPMG advises we're "on the cusp of revolutionary change" coming much "sooner than you think."

Even one legendary MIT professor had to recant his position that the technology was "beyond the capability of computer science." (He recently confessed to The Wall Street Journal that he's now a believer and amazed "how quickly this technology caught on.")

Yet according to one J.D. Power and Associates survey, only 1 in 5 Americans are even interested in this technology, much less ready to invest in it. Needless to say, you haven't missed your window of opportunity. 

Think about how many amazing technologies you've watched soar to new heights while you kick yourself thinking, "I knew about that technology before everyone was talking about it, but I just sat on my hands." 

Don't let that happen again. This time, it should be your family telling you, "I can't believe you knew about and invested in that technology so early on."

That's why I hope you take just a few minutes to access the exclusive research our team of analysts has put together on this industry and the one stock positioned to capitalize on this major shift.

Click here to learn about this incredible technology before Buffett stops being scared and starts buying!

David Hanson owns shares of Berkshire Hathaway and American Express. The Motley Fool recommends and owns shares of Berkshire Hathaway, Google, and Coca-Cola.We Fools don't 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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