The Street's FDA Drug Approval Contest: October's FDA Calendar

Image representing TheStreet as depicted in Cr...Image via CrunchBase Here is Ocotber's FDA Calendar. Along with the Calendar I have put my recommendation for each stock. Some you should really be buying, like Alkermes, others you should be shorting, like Arena, Vivus, and Jazz Pharma.

The poll has 3 results:
1. Full Approval
2. Complete Response Letter (aka delayed approval or no approval)
3. No Decision (more time, the FDA has a lot of approvals in such a given short period)

Oct. 1: Hospira's(HSP) Dyloject for acute moderate to severe pain in adults. (CRL)---Big Company so no big deal, still a buy

Oct. 4: Human Genome Sciences'(HGSI) Zalbin for hepatitis C. (CRL--Lupus drug approval set for December so still a buy)

Oct. 11: Alexza Pharmaceuticals'(ALXA) AZ-004 for agitation in patients with schizophrenia or bipolar disorder. (I'm going with No Decision, short this stock, as this is their first FDA decision for the Staccato technology) Slightly leaning toward CRL but I will say No Decision as my final answer.

Oct. 11: Jazz Pharmaceuticals'(JAZZ) JZP-6 for fibromyalgia. (CRL--FDA panel killed this drug, it works but the FDA isn't approving a GHB type drug right now. Short this stock)

Oct. 12: Alkermes'(ALKS) Vivitrol for opioid addiction. (Full Approval--Jim Cramer would say Buy, Buy Buy)

Oct. 16: ISTA Pharmaceutical (ISTA) XiDay is simply aonce daily version of twice daily solution, and avoid generic competition (FDA Approval)

Oct 22: Arena Pharmaceuticals'(ARNA) lorcaserin for obesity. (No way in he##, CRL) I would recommend shorting this stock.

Oct 22: Amylin Pharmaceuticals(AMLN) (Partnered with Alkermes and Eli Lilly) Once weekly Diabetes Shot exenatide or Bydureon---This is a delay from CRL in March so I expect Full Approval this time around.

Oct 28: Vivus'(VVUS) Qnexa for obesity. (Give me a break, CRL) I don't care what data they have come up with, I would recommend Shorting this stock.

Oct 29: Avanir Pharmaceuticals'(AVNR) Zenvia for pseudobulbar affect. (I'm going to go with Full Approval although it's a toss-up)

Forest Labs(FRX) ceftaroline for Community Acquired Pneumonia. I can't find this on the FDA calendar---But I will say Full Approval even though I can't find it.

Oct 30: Biodel's(BIOD) Linjeta for diabetes. (No Decision, short this stock) Again on the fence, possible CRL.

BOSTON (TheStreet) -- The opioid addiction drug from Alkermes(ALKS) is a lock for U.S. approval later this month, as are a new diabetes drug from Amylin Pharmaceuticals(AMLN) and partners and an antibiotic made by Forest Labs(FRX) .

The respective weight-loss drugs from Arena Pharmaceuticals(ARNA) and Vivus(VVUS) , however, stand almost no chance of receiving the backing of U.S. drug regulators.

Those are some of the consensus opinions that stand out from 80 readers (so far) who submitted entries to TheStreet's FDA Drug-Approval Contest. I spent part of my weekend number crunching your predictions and came away with results that I'd say largely encompass broader investor expectations with some exceptions.

Let's start with the consensus favorites: Alkermes tops the list, with 84% of readers predicting full approval for Vivitrol opioid, the company's once-monthly injectable drug to treat opioid addiction. That's an overwhelming consensus but perhaps not surprising given the positive recommendation for Vivitrol's approval from an FDA advisory panel on Sept. 16.

The FDA is expected to make its approval decision known on Oct. 12. If you believe in the efficiency of markets, then Alkermes' stock price already bakes in Vivitrol's approval, although perhaps not the drug's commercial potential.

Readers were equally decisive, albeit in the other direction, about the weight-loss drugs currently under review at the FDA. By margins of 85% and 80%, respectively, readers believe FDA will issue complete response letters to Arena Pharmaceuticals and Vivus.

That readers expect FDA to hold off on approving these obesity drugs isn't surprising given the negative votes from the U.S. advisory panels that reviewed Arena's lorcaserin and Vivus' Qnexa. The beaten-down stock prices of both Arena and Vivus certainly mirror these sentiments already.
I am somewhat surprised, however, by the large margins for which readers believe FDA will reject these weight-loss drugs later this month. The bull-bear debate over Arena's lorcaserin and Vivus' Qnexa raged red-hot this year, so to see such unanimity of opinion now is a change.

From an investment standpoint, it's hard to make money when everyone agrees, so let's take a look at upcoming FDA drug-approval decisions where readers have decidedly mixed views.

Alexza Pharmaceuticals(ALXA) appears to be the "battleground" drug-approval stock in October. Thirty-six percent of readers believe FDA will approve Alexza's AZ-004 (Staccato loxapine) for agitation in patients with schizophrenia or bipolar disorder. The optimists are countered by 41% of readers who say FDA will issue a complete response letter and another 23% who believe FDA won't make a decision at all.

A toss-up result like that suggests some volatility ahead for Alexza shares if or when FDA issues the approval decision on Oct. 11.

Another drug approval decision perhaps too close to call is Avanir Pharmaceuticals(AVNR) and the drug Zenvia for pseudobulbar affect. Forty-one percent of readers expect FDA full approval on Oct. 29; 36% expect an FDA complete response letter; and another 23% say FDA will push the approval decision down the road to a later date.

Other results from number-crunching the predictions gathered as part of TheStreet's FDA Drug-Approval Contest:

69% believe FDA will grant full approval to Forest Labs' (FRX) antibiotic ceftaroline on Oct. 30.

Biodel's(BIOD) fast-acting insulin Linjeta looks like it still has an India data problem, given that 60% of readers say a complete response letter from FDA is on its way.

Likewise, the FDA advisory panel that beat up on Jazz Pharmaceuticals(JAZZ) and its fibromyalgia drug JZP-6 has 73% of readers predicting a complete response letter from FDA on Oct. 11.

Human Genome Sciences(HGSI) previously disclosed that FDA wasn't likely to approve its hepatitis C drug Zalbin on Oct. 4 (that's today), so maybe it's surprising that 24% of readers still say the drug is getting approved. Do these folks know something that the others don't?

It's not too late to submit your own predictions for the FDA drugs approval decisions in October. Entries received after the start of October are eligible for the contest, but you won't get credit for drug-approval decisions already made by the time your entry was received.

Learn more about the FDA Drug Approval Contest and submit your entry here.
--Written by Adam Feuerstein in Boston.
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