GO
Loading...

Best and Worst FDA Drug Approval Stocks of 2013

Emmanuel Faure | Stone | Getty Images

Bad news from Europe is in store for Arena Pharmaceuticals. FDA advisory panels will deal harshly with Delcath Systems and Aveo Pharmaceuticals. An early approval filing is in the cards for Sarepta Therapeutics, and Ziopharm Oncology's sarcoma drug emerges as a winner. These are some of the predictions made by investors who submitted entries to TheStreet's latest FDA Drug Approval Contest.

I hesitate to call these picks "consensus," but 113 entries are a decent sample size from which to gauge retail investor sentiment. Accuracy can also be hit and miss. The crowd participating in my previous two FDA approval contests was correct 80 percent and 57 percent of the time, respectively.

I crunched the numbers. Here are your predictions:

Sarepta Therapeutics: 55 percent of investors believe the FDA will grant permission to seek accelerated approval for eteplirsen. Forty-five percent predict no accelerated approval. There isn't much daylight between those two numbers. I've written previously about Wall Street investors leaning more bearish on the accelerated approval decision, so it doesn't surprise me to see a more bullish stance taken by retail investors, even if just a slight one.

Arena Pharmaceuticals: Investors who entered my contest take a dim view of Belviq's approval prospects in Europe. The margin was huge: 76% predict European regulators will reject the weight-loss pill, while only 24% say it will be approved. Areniacs like to shout "Idiot!" (or worse) at anyone who dares to suggest European regulators will be less than sanguine about Belviq's mediocre efficacy and still-unanswered questions about its long-term safety. Surprise, it's the Areniacs who are in the minority.

Titan Pharmaceuticals: Seventy-two percent of respondents predict a recommendation favoring Probuphine's approval by an FDA advisory panel. Twenty-eight percent say the panel will vote against the implantable formulation of buprenorphine.

A.P. Pharma: Approval by the FDA of APF530: 63 percent. Rejection: 37 percent.

Biogen Idec: FDA approval of BG-12: 87 percent. Rejection: 13 percent.

United Therapeutics: FDA approval of oral Remodulin: 60 percent. Rejection: 40 percent. FDA appeared to come down hard on oral Remodulin when the drug was rejected last year, but then regulators granted United Therapeutics a surprisingly short review period after the drug was resubmitted (without new clinical data).

Sucampo Pharmaceuticals: FDA approval of Amitiza: 76 percent. Rejection: 24 percent.

Navidea Biopharmaceuticals: FDA approval of Lymphoseek: 72 percent. Rejection: 28 percent.

Raptor Pharmaceuticals: FDA approval of Procysbi: 81 percent. Rejection: 19 percent.

Aveo Pharmaceuticals: The bears growl again. Fifty-seven percent of respondents expect the FDA advisory panel to vote against Tivopath; 43 percent look for a positive vote. Aveo's argument that Nexavar crossover mucked up Tivopath's survival benefit doesn't appear to be persuasive to investor contestants.

Delcath Systems: Fifty-four percent predict the FDA panel will slap down Melblez; 46 percent say it will be positive. Close again, though leaning bearish. But check this out: 64 percent predict the FDA will ultimately reject Melblez, while 35 percent say it will be approved. Weird. Is it a fluke that more people predict Melblez's FDA rejection than a negative panel? That suggests a group of investors believe FDA will overturn a positive vote by the panel—a relatively rare outcome.

Sure enough, 11 contestants—almost 10 percent of total entrants—predict a positive FDA panel for Melblez followed by an FDA rejection. Very interesting. If you're in this group and happen to read this column, drop me an email and explain your thinking.

Ziopharm Oncology: Another runaway, with 78 percent predicting positive results from the palifosfamide clinical trial versus just 22 percent believing the trial comes up negative. If everyone is so confident in a Ziopharm win, why doesn't the stock trade better going into the results announcement at the end of March?

For anyone interested, my personal picks are in line with consensus with the exception of United Therapeutics, where I predict FDA rejection of oral Remodulin.

I voted yes on Sarepta accelerated approval filing, no on Arena in Europe, a positive Titan panel, FDA approvals for A.P. Pharma, Biogen, Sucampo, Navidea and Raptor. I'm on the fence with Aveo's FDA panel but ultimately predicted a negative vote (just barely, I can see it going the other way, too). I'm definitely negative on Delcath's FDA panel and the ultimate FDA approval decision. Finally, I'm also positive on Ziopharm.

By TheStreet.com's Adam Feuerstein

Additional News: US Treasury Sold $489.9 Million of GM Stock in February

Additional Views: Optimism on Possible Budget Deal Fuels Bulls

___________________________
Disclosures:

At the time of publication, Adam Feuerstein had no positions in the stocks mentioned.

TheStreet does not permit any employees on its editorial staff to individually hold positions in individual stocks, though they are permitted to own stock in TheStreet.

___________________________

Disclaimer