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What: Shares of Onyx Pharmaceuticals
So what: The FDA approved Kyprolis for patients with multiple myeloma who have failed at least two prior therapies, and exhibited disease progression 60 days or less from that last treatment. Under the accelerated approval program, Onyx will still need to submit further clinical data supporting the efficacy of the drug. The big news here is that despite the heart, lung, and liver concerns raised previously, the FDA decided to side with the unanimous recommendation of its panel and approve Kyprolis, which eliminated or partially reduced the targeted cancer in 23% of patients tested.
The other news is related to Bristol-Myers' advanced liver cancer pill, brivanib, which failed in a second late-stage trial, according to the company. According to Bristol-Myers, patients using Onyx's Nexavar lived longer.
Now what: This is one story that has big implications for numerous companies involved. Obviously Onyx is a big winner, but another unsung hero here is Ligand Pharmaceuticals
Overall, Onyx looks well on its way to being a blockbuster biotech. Even after a huge run and with a market value of $5 billion, I haven't thrown the idea of it being scooped up by a larger pharmaceutical company out the window just yet.
Craving more input? Start by adding Onyx Pharmaceuticals to your free and personalized Watchlist so you can keep up on the latest news with the company.
Editor's Note: The Motley Fool has updated this article to reflect more accurately the patient population approved for Kyprolis.
Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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