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Biotech day traders tend to focus on Food and Drug Administration approvals as their binary event of choice because the decisions are usually handed down on or around the company's PDUFA date.
But clinical trial results can have an equally appealing result. Amarin (Nasdaq: AMRN ) is up 600% over the last year after two positive clinical trials for its cholesterol drug AMR101. Investors willing to stay in a stock a little longer -- companies usually narrow down the data release to a quarter or two -- can see substantial gains well ahead of FDA approvals.
Here's a handful of biotechs with upcoming clinical trial results.
Little now, big later
Exelixis (Nasdaq: EXEL ) is expecting phase 3 data for cabozantinib in medullary thyroid cancer shortly. There's little chance that the fairly rare cancer is going to make the drug a blockbuster, but a positive phase 3 trial would be a sign that the drug works.
Cabozantinib blocks the MET and VEGF pathways that are involved in tumor growth in multiple tumor types. In addition to medullary thyroid cancer, cabozantinib is in clinical trials for prostate, ovarian, and other cancers that could easily make the drug a blockbuster.
Four trumps three
The phase 3 trials for Gilead Sciences' (Nasdaq: GILD ) HIV quad pill will be completed in the third quarter of this year, but that doesn't necessarily mean the data will be available by Sept. 30. There's a lot of number crunching that needs to go on after the last patient's viral levels are read, which could push the top-line results into the fourth quarter.
The quad pill is important for Gilead because it owns all four drugs in the cocktail unlike Atripla, which combines two of its drugs with Bristol-Myers Squibb's (NYSE: BMY ) Sustiva. The quad pill only has to work as well as Atripla for it to be a financial success for Gilead. That certainly seems possible if the larger trials are consistent with the phase 2 data.
Final results for Medivation's (Nasdaq: MDVN ) phase 3 trial testing MDV3100 in prostate cancer aren't expected until next year, but the company -- in consultation with its partner Astellas -- have decided to take an interim look at the data. If the drugs effect has already reached statistical significance, the trial will be stopped and called a success, otherwise it'll continue through to the end.
Unlike Gilead's trial, where the company knows when the last patient entered the trial and therefore when the last patient will receive his or her 48-week follow-up, the trial for MDV3100 is events driven. The readout will occur after a certain number of deaths. Medivation says "data from the interim analysis could potentially be available in 2011." That's as close as you're going to get.
Ironically, the longer the data is delayed, the better it may be -- assuming, of course, the delay isn't because the control group is living longer than expected.
Waiting it out
Vical's (Nasdaq: VICL ) investors have been patiently waiting for the phase 3 results for its skin cancer treatment, Allovectin, through five safety analyses. Unlike an interim peek at the data, these safety analyses can't really help the company. The safety monitoring board takes a look at how the patients are faring and will stop the trial if the drug is doing more harm than good. The best investors can hope for is that the board recommends continuing the trial, which it did. Unfortunately, that doesn't give much indication as to whether the trial will be a success.
The trial, which has been going on since January 2007, may finally reach the required number of deaths in the second half of the year and investors can get the answer they've been waiting so long for.
YM BioSciences (AMEX: YMI ) expects to have full data for a phase 2 trial testing nimotuzumab in children with glioma in the third quarter, but investors can get an early look at the data that will be presented at the American Society of Clinical Oncology this week. The abstract, which is already available, says that the overall survival was 81.5% one year after treatment. While there isn't a comparator arm in the trial and the data was only for 12 patients, it sure seems like the drug is doing something.
News at 11
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