Onyx nailed an FDA approval today for the multiple myeloma drug Kyprolis (carfilzomib), overcoming the naysayers who were skeptical that the agency would hand out an accelerated OK for a new drug on just mid-stage data drawn from a single-arm study.
On Wall Street, the math on any possible biotech M&A deal often plays out along a best-case scenario for drug developers riding a wave of enthusiasm. Now Onyx is riding that wave since it breezed through a panel review of its multiple myeloma drug carfilzomib.
While Onyx unexpectedly found itself facing a friendly group of supporters during its FDA panel session on carfilzomib, Celgene shocked a number of analysts with the news that it is yanking its European application for Revlimid as a treatment for multiple myeloma in newly diagnosed patients after regulators there passed along the word that they would prefer to wait for more "mature" data.
Onyx's risky attempt to win an approval for the multiple myeloma drug carfilzomib on the basis of mid-stage data from a single-arm study cleared a major hurdle yesterday evening when an FDA advisory group gave its drug a unanimous thumbs up.
Ahead of a key advisory committee meeting this week, the FDA posted a staff assessment about the merits of greenlighting Onyx Pharmaceuticals' ($ONXX) closely watched cancer drug carfilzomib for multiple myeloma.
Reuters reported today that Bayer is looking to close a multibillion-euro acquisition deal, quoting sources who say that an announcement could be "imminent."
Thousands of experimental meds are winding their way through various stages of clinical trials today, and the largest category among the contenders is cancer drugs.
Onyx Pharmaceuticals' ($ONXX) financial chief rattled off the reasons why the cancer drug company would make a nice buyout option in an interview with Bloomberg, walking a fine line by declining to
Shares of Onyx ($ONXX) slid 6% this morning on the news that it will have to settle for a standard review of its closely-watched cancer drug carfilzomib after failing to win an accelerated review.
Take your pick. There are a number of Big Pharma outfits that might benefit from scooping up South San Francisco cancer drug developer Onyx Pharmaceuticals ($ONXX), which has reportedly hired a