FDA grants Priority Review to regorafenib NDA for GIST

Bayer AG (Xetra:BAYN) and partner Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) said FDA accepted for review and granted Priority Review to an NDA for regorafenib to treat metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment. Bayer submitted the NDA in late August; a six-month Priority Review would place the PDUFA date in late February or early March. A specific date was not disclosed. Onyx has co-promotion rights in the U.S. to the dual acting signal transduction (DAST) inhibitor of multiple kinases and is eligible for a 20% royalty on worldwide sales. ...