If you're a gambler looking for a little 'action' from the stock market, than you may want to take a look at Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX). Just do it quickly, 'cause the roulette wheel is about to stop and the ball's going to drop somewhere. The due-date is Thursday, February 28th, or sooner. That's the day we hear from the FDA about whether or not the company's drug Stiverga has been approved by the FDA, though it's possible the administration could announce a decision sooner.
Working in favor of ONXX and Stiverga is the fact that the drug - a treatment for gastrointestinal stromal tumors - was granted a priority view. This type of FDA review is shortened in order to expedite the approval because the drug in question is seen as filling a high-need area, and time is of the essence. That doesn't inherently guarantee an approval, but it does suggest the Food and Drug Administration recognizes there's something of a hole that needs to be plugged as soon as possible.
Something else working in Stiverga's favor (and by default, in favor of Onyx Pharmaceuticals shareholders)...it's already been approved metastatic colorectal cancer for patients who have already exhausted the use of other forms of testaments. Though that doesn't speak to the efficacy of the drug as a treatment for GIST, it does speak to the safety profile of the drug.
That being said, Onyx Pharmaceuticals' phase 3 trials DO speak to the drug's efficacy. And, there's something to it. For the nearly 200 patients who were administered the treatment, the average tumor progression (of growth) was delayed 3.9 months. It may not seem like a lot, but in drug terms - when being compared to other drugs trying to do the same thing - that's a pretty significant improvement.
If approved, Bayer and Onyx will co-market the drug, and Bayer will carry it alone in other markets. ONXX will receive a royalty of 20% of sales. Some say the drug could generate as much as $1.3 billion in sales, which means this is treatment that could mean $300 million or more to Onyx Pharmaceutical's top line.