- 69% believe FDA will grant full approval to Forest Labs' 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 - Get Report) 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?
BOSTON ( TheStreet) --The opioid addiction drug from Alkermes ( ALKS - Get Report) 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 - Get Report), 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: