Today’s Top Biotech Stories: Insmed, Exelixis, United Therapeutics, and Alnylam

Insmed, Exelixis, United Therapeutics, and Alnylam could all make biotech headlines this morning. Here’s why.

Mar 26, 2014 at 9:11AM

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 four stocks -- Insmed (NASDAQ:INSM), Exelixis (NASDAQ:EXEL), United Therapeutics (NASDAQ:UTHR), and Alnylam (NASDAQ:ALNY) -- which could all loom large in health care headlines this morning.

Insmed's lung infection drug fails a mid-stage trial
Insmed is down 9% in premarket this morning after reporting that its lung infection drug, Arikayce/Arikace, failed to meet the main goal of a phase 2 trial on patients with nontuberculous mycobacterial lung infections. Insmed does not have any marketed products.

This setback is a devastating blow for Insmed, since Arikayce is the company's only pipeline product. The drug was being tested for three kinds of lung infections. The most advanced indication, pseudomonas aeruginosa lung infections in cystic fibrosis patients, has reached phase 3 trials in Europe and Canada. The third indication, for pseudomonas aeruginosa lung infections in non-cystic fibrosis patients, has completed a phase 2 study.

Piper Jaffray, which reiterated its Overweight rating on the stock, noted that although the study failed to meet its primary endpoint, it met a "much more meaningful and clinically relevant" secondary endpoint of culture conversion.

Exelixis plunges after reporting the completion of an interim analysis
Meanwhile, Exelixis, which just reported the European approval of Cometriq yesterday, is down 30% in premarket this morning. Exelixis announced that an Independent Data Monitoring Committee (IDMC) had notified the company that a planned interim analysis of the COMET-1 phase 3 pivotal trial had been completed, and that the IDMC has recommended that the trial proceed to its final analysis. The company also stated that it continues to anticipate top-line data from the COMET-1 trial later this year.

COMET-1 is Exelixis' closely watched trial testing Cometriq as an advanced prostate cancer treatment, a potentially major indication for the drug.

United Therapeutics' Remodulin is approved in Japan
United Therapeutics just announced that Japan's Ministry of Health, Labor, and Welfare has approved Remodulin, its injected treatment for pulmonary arterial hypertension (PAH).

The drug will be sold in Japan under the brand name Treprost by Mochida Pharmaceutical, which previously signed an exclusive distribution agreement with United Therapeutics. Sales of Remodulin and Tyvaso, an inhaled version of the drug, accounted for 83% of the company's top line in fiscal 2013.

Orenitram, a new oral drug which contains the same active ingredient as Remodulin and Tyvaso, was approved last December and is expected to generate peak sales of $200 million to $300 million -- which could be a big boost for a company which reported $1.1 billion in revenues in 2013.

Sanofi boosts its investment in Alnylam
Last but not least, Sanofi's (NYSE:SNY) Genzyme unit just boosted its investment in Alnylam Pharmaceuticals, which studies RNAi therapeutics. Genzyme, which is focused on rare disease and multiple sclerosis treatments, exercised its right to buy 344,448 unregistered shares of Alnylam common stock.

Based on Alnylam's closing price of $66.88 on March 25, the transaction is valued at approximately $23 million. Genzyme now owns 12% of Alnylam's common stock. The two companies have been partnered since January in the development and commercialization of RNAi therapeutics as genetic medicines. Under that agreement, Genzyme purchased 8.8 million shares of new Alnylam stock for approximately $80 per share.

Alnylam doesn't have any marketed products, but its pipeline of a wide variety of genetically targeted treatments for amyloidosis, hemophilia, hypercholesterolemia, iron overload disorders, hyperlipidemia, and other indications.

Sanofi's investment in Alnylam is significant, since it has a history of investing in promising next generation technologies, such as its partnership with Regeneron in the development of fully human monoclonal antibodies. Sanofi recently considered raising its stake in Regeneron from 16% to 30%. This recent vote of confidence for Alnylam could increase bullish interest in the company, which has already rallied 180% over the past 12 months.


3 stocks that could become your next huge winner
The one sure way to get wealthy is to invest in a groundbreaking company that goes on to dominate a multibillion-dollar industry. Our analysts have done it before with the likes of Amazon and Netflix. And now they think they've done it again with three stock picks that they believe could generate the same type of phenomenal returns. They've revealed these picks in a new free report that you can download instantly by clicking here now.

Leo Sun has no position in any stocks mentioned. The Motley Fool recommends Alnylam Pharmaceuticals and Exelixis. The Motley Fool owns shares of Exelixis. Try any of our Foolish newsletter services free for 30 days. 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.

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.

©1995-2014 The Motley Fool. All rights reserved. | Privacy/Legal Information