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What: Shares of Onyx Pharmaceuticals (NAS: ONXX) are rocketing higher again, by as much as 16%, after receiving approval from the Food and Drug Administration for its blood cancer drug, Kyprolis, and following a late-stage drug failure from Bristol-Myers Squibb (NYS: BMY) .
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 (NAS: LGND) which supplies the key ingredient in Kyprolis, captisol, and is Onyx's royalty partner. Celgene (NAS: CELG) , on the other hand, is going in the opposite direction, although it really shouldn't be. Celgene's Revlimid and Takeda Pharmaceuticals' Velcade are the go-to initial treatments for relapsed and refractory multiple myeloma; Onyx's Kyprolis is merely the back-up in case those treatments aren't tolerated or are ineffective with patients.
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.
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Editor's Note: The Motley Fool has updated this article to reflect more accurately the patient population approved for Kyprolis.
The article Why Onyx Pharmaceuticals Shares Turned Into Gold originally appeared on Fool.com.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. Try any of our Foolish newsletter services free for 30 days. We Fools don't 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.
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