FDA offers Bayer, Onyx fast review for regorafenib

Bayer HealthCare and Onyx Pharmaceuticals ($ONXX) won an inside track at the FDA today for their closely-watched cancer drug regorafenib. The FDA gave the promising treatment priority review status, which should shave four months off the standard 10-month review. That will put the deadline for a marketing decision in late October, though regulators have sometimes been willing to offer approvals even faster than that when they're excited by a new therapy. Both companies have a lot riding on the outcome. Bayer is using the program as an example of its commitment to expand the cancer drug portfolio while Onyx, which owns a hefty slice of the royalties, sees the treatment adding significant value to the company. Report

 

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