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Bayer Aktienges Ads (BAYRY.PK) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) report that they have submitted a New Drug Application to the FDA for their oral multi-kinase inhibitor regorafenib for the treatment of gastrointestinal tumors in patients whose disease has progressed with prior treatment. Both firms will jointly market the drug in the United States, and Onyx will receive a royalty on any future worldwide net sales.
Linzess, which was developed by Forest Laboratories, Inc. (NYSE:FRX) and Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults, has been approved by the FDA. The med is a capsule which is taken once a day on an empty stomach, and at least 30 minutes before the first meal of the day. Meanwhile, shares of Synergy Pharmaceuticals, Inc. (NASDAQ:SGYP) moved upon the news of Linzess’approval, as the company’s own medication Plecanatide shares the same origins and mechanism of action as Linzess; results from recently-closed Phase IIb/III trials on Synergy’s drug should be out by the end of December.
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