5 Biotechs With Upcoming Clinical Trial Results

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

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
(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.

Sneak peek
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
'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.

Early results
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
If you'd like to follow the Fool's take as the companies release their data, click below to add them to your watchlist.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Exelixis. Motley Fool newsletter services have recommended buying shares of Exelixis and Gilead Sciences. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Read/Post Comments (1) | Recommend This Article (2)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Add your comment.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 1501428, ~/Articles/ArticleHandler.aspx, 10/22/2016 3:16:21 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated 6 hours ago Sponsored by:
DOW 18,145.71 -16.64 -0.09%
S&P 500 2,141.16 -0.18 -0.01%
NASD 5,257.40 15.57 0.30%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

10/21/2016 4:00 PM
AMRN $3.20 Up +0.04 +1.27%
Amarin CAPS Rating: ****
BMY $50.02 Down -0.34 -0.68%
Bristol-Myers Squi… CAPS Rating: ****
EXEL $11.56 Down -0.18 -1.53%
Exelixis CAPS Rating: ****
GILD $74.29 Down -0.02 -0.03%
Gilead Sciences CAPS Rating: *****
MDVN $0.00 Down +0.00 +0.00%
Medivation CAPS Rating: ****
VICL $2.91 Down +0.00 +0.00%
Vical CAPS Rating: ***
YMI.DL2 $0.00 Down +0.00 +0.00%
YM BioSciences, In… CAPS Rating: ****