7 FDA Decisions You Can't Afford to Ignore in Q4

Just because Greece appears dangerously close to falling off a cliff, that doesn't mean biotech companies worldwide stop spending money on research and development. On the contrary, the fourth quarter is shaping up to be an exciting few months for the biotechnology sector, with 12 drugs being weighed for approval by the Food and Drug Administration.

It's simply impossible to determine whether a drug will be approved based solely on clinical trial data, BT those trials can offer insight into the chances a drug has of getting the nod of approval from the FDA. I've highlighted seven companies that interest me the most this quarter, as well as the new drugs they're trying to bring to market.




FDA Decision Date

Bristol-Myers Squibb (NYSE: BMY  ) dapagliflozin Treatment of Type 2 diabetes mellitus 10/28/2011
BioSante Pharmaceuticals (Nasdaq: BPAX  ) , licensed by Teva Pharmaceuticals (Nasdaq: TEVA  ) Bio-T-Gel Treatment of male hypogonadism or low testosterone levels 11/14/2011
Regeneron Pharmaceuticals (Nasdaq: REGN  ) EYLEA Treatment of neovascular age-related macular degeneration 11/18/2011
Transcept Pharmaceuticals (Nasdaq: TSPT  ) Intermezzo Sleep aid for middle-of-the-night awakenings 11/27/2011
Incyte (Nasdaq: INCY  ) Ruxolitinib Treatment for myelofibrosis 12/3/2011
Antares Pharma (AMEX: AIS  ) Anturol Gel Treatment for overactive bladder 12/8/2011

Source: RTT News.Dapagliflozin, developed in collaboration with AstraZeneca, is under review in Europe and the United States, and it's my suspicion that its chances of approval in the U.S. seem pretty good. Bristol-Myers' 24-week phase 3 clinical trial showed a significant mean reduction in those newly diagnosed with Type 2 diabetes. Don't expect a big pop from the stock if approved, but do expect this to add to an already diverse pipeline.

Originally developed by BioSante, Bio-T-Gel is now fully licensed and marketed by Teva, with BioSante scheduled to receive milestone payments from the eventual sale of the drug. The male-testosterone market is a $1.2-billion-a-year industry, so there's definitely the possibility for a pop here, especially on BioSante's side if the drug is approved.

EYLEA had better be everything Regeneron has built the drug to be, because at 12 times book value and with years of losses still looming, it will need EYLEA to be a blockbuster to maintain its $5.8 billion valuation. Recently the company has benefited from news that Roche's competing drug Avastin may have caused adverse side effects on patients in California. Either way, this is one company where owning puts may come in handy.

For a company like Transcept, this FDA decision has make-or-break potential for the stock. I have to admit that I'm still not very bullish on Transcept even if Intermezzo gets approved because of the sheer number of competitors already in the insomnia/sleep-disorder sector. I could very well be wrong, but Somaxon me once, shame on me, Transcept me twice ... you know the rest.

Incyte may offer the most exciting drug of the bunch with Ruxolitinib for the treatment of myelofibrosis. In clinical trials, roughly a third of patients showed a 35% or greater reduction in spleen size, a primary symptom of this blood-borne cancer. I wouldn't go so far as to guarantee an approval, but I think Incyte's drug offers the greatest potential for approval of all the drugs listed in the table and could easily surpass the $1 billion sales mark within a few years.

Finally, we have Antares and its overactive-bladder drug Anturol Gel. With the company having other successful products already on the market and analysts projecting a profit in 2012, I don't see this FDA decision having a huge impact on the stock price either way. Clinical trials did show that Anturol Gel met its efficacy goals, but I'd call the potential approval possibility here no higher than a toss-up.

There you have it, folks -- seven companies you can count on to liven up the biotech space over the course of the next three months. I can't say for certain who will succeed or who might go down in flames, but I can say that it never hurts to buy yourself a little protection (i.e., puts) if you currently own one or more of the names we've discussed here.

Which company on this list are you most anticipating an FDA decision from? Share your thoughts in the comments section below, and consider adding these seven biotechs to your free and personalized watchlist to keep track of the latest news that's sure to move these companies.

Fool contributor Sean Williams has no material interest in any other companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong and on Twitter, where he goes by @TMFUltraLong. The Motley Fool owns, and Motley Fool newsletter services have recommended buying, shares of Teva Pharmaceutical. Try any of our Foolish newsletter services free for 30 days. 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 that cures your ills with transparency.

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