MAP Gets FDA Approval, Bayer’s New Cancer Drug: Healthcare Business Recap
In a Wednesday press release, MAP Pharmaceuticals (NASDAQ:MAPP) reported that the FDA has accepted for filing its New Drug Application resubmission for the Lexadex orally inhaled migraine medication for the potential acute treatment of migraine in adults, classifying the resubmission as a complete Class 2 response to the its March 26th action letter. The agency has set a target date of April 15th under the Prescription Drug User Fee Act. Shares gained more than 20 percent on Friday’s short trading day.
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Regorafenib, which is a new drug from Bayer (BAYZF.PK), might significantly broaden the survival prospects of people suffering from gastrointestinal stromal tumors, according to new research published in the United Kingdom’s medical journal, The Lancet, which also reported that survival rates for patients with metastatic bowel cancer were also improved, though not as significantly. This new research comes from two separate trials and it is thought that it should improve the prospects of the drug, which Bayer says is one of its most significant new pipeline products. The drug is also known as Stivarga and currently is jointly promoted by Bayer and Onyx Pharmaceuticals (NASDAQ:ONXX) in the United States.