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Normally we have a nice blend of health-care events to take notice of each week. This week I'm steering you squarely toward the biotechnology sector, which has two big FDA decisions due, as well as earnings reports from three highly followed biotechs.
Beginning with the FDA decisions, Onyx Pharmaceuticals (UNKNOWN: ONXX.DL ) , which reported much better-than-expected earnings results last week, is slated to receive a decision on Stivarga by Feb. 28. Stivarga, which is being developed with Bayer and is designed to treat gastrointestinal stromal tumors, was approved by the FDA in late September as a secondary treatment for metastatic colorectal cancer. The drug looks to be in line to gain an addition indication given that, in phase 3 trials, it produced a progression-free survival of 4.8 months, as compared with just 0.9 months for the control arm. Onyx has been on a tear lately, and an approval would just be icing on the cake.
On the flipside, Zogenix (NASDAQ: ZGNX ) is expected to go before the firing squad on March 1, for Zohydro ER, its moderate to chronic pain management drug. The all-oral drug, which is safer for the liver since it uses hydrocodone without acetaminophen, excelled in late-stage trials, but was knocked off the ladder by the FDA's panel in December, falling more than 50%. The panel voted 11-2, with one abstention, against recommending Zohydro ER for approval primarily because of its abuse potential. Although the FDA isn't required to follow the recommendation of its panel, I'd be shocked if Zohydro ER was approved on Friday.
In the earnings column, Ariad Pharmaceuticals (NASDAQ: ARIA ) is scheduled to report on Monday. While the current quarter isn't expected to hold any major surprises, investors will be waiting on the edge of their seats for Ariad's 2013 revenue guidance. Iclusig, Ariad's drug developed to treat two rare forms of leukemia, was approved in December, and sales estimates from analysts have been all over the place, considering the black box warning placed on the drug. Keep a close eye on Ariad's 2013 revenue figures, as it'll give us a better idea of how quickly it expects sales to ramp up.
The highly embattled Questcor Pharmaceuticals (UNKNOWN: QCOR.DL ) is up to bat on Tuesday and is expected to deliver sales growth of roughly 89% and EPS of $1, more than double what it reported last year. There's little question Questcor's been raking in profits, given the 19 current indications for its Acthar Gel; however, the company also faces the ongoing overhang of a U.S. government probe into its marketing activities. As we saw with ABIOMED, sometimes these probes end favorably with no penalties assessed; and sometimes they end with a whopper of a penalty, as Johnson & Johnson found out when it paid $2.2 billion in settlements last year. Clearly, Quesctor's bottom-line numbers matter, but I'd almost prefer to hear more about what's going on with the investigation.
Finally, Medivation (NASDAQ: MDVN ) is expected to report its year-end results on Feb. 28. As with Ariad, losses are expected, but investors will be waiting on pins and needles to see what Medivation has to say about sales of advanced prostate cancer drug Xtandi. The drug was approved three months earlier than its PDUFA date -- a rarity, as my Foolish colleague Brian Orelli noted at the time -- so expectations for the drug are high. For the quarter, sales are expected to rise 130% to $34.4 million, but growth could slow to just 21% next year. Look for Medivation to soothe investors' growth concerns with additional info regarding its potential for approval in Europe, or its possible use in earlier stages of prostate cancer treatment within the U.S. in the future.
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