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February 27, 2013
06:34 EDTAVEOAveo Pharmaceuticals' NDA for tivozanib to be reviewed by FDA on May 2
AVEO and Astellas Pharma Global Development, a U.S. subsidiary of Tokyo-based Astellas Pharma, announced that the FDA's Oncologic Drugs Advisory Committee will review the company's New Drug Application for tivozanib for the treatment of patients with advanced renal cell carcinoma during the morning session of its meeting on May 2. ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer, and makes recommendations to the Commissioner of Food and Drugs. The review of the NDA is expected to be complete by July 28. Tivozanib is an investigational medicine and is not currently approved in any country.
News For AVEO From The Last 14 Days
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May 20, 2015
09:25 EDTAVEOOn The Fly: Pre-market Movers
UP AFTER EARNINGS: American Eagle Outfitters (AEO), up 8.6%... Computer Sciences (CSC), up 4.1%. ALSO HIGHER: Sarepta Therapeutics (SRPT), up 44.5% after announcing plans for rolling eteplirsen NDA... Genocea Biosciences (GNCA), up 22.5% after GEN-003 Phase 2 trial met primary endpoint... IsoRay (ISR), up 31.7% after Cesium-131 reports 96% success in local control and 100% survival in 5 years... AVEO Pharmaceuticals (AVEO), up 15.7% after presenting results of extension study 902 and gets FDA feedback for tivozanib... Pep Boys (PBY), up 12.5% following reports that potential buyer have approached the company about a possible takeover. DOWN AFTER EARNINGS: Etsy (ETSY), down 19.5%... China Distance Education (DL), down 7.7%... Keysight Technologies (KEYS), down 5.7%.... Lowe's (LOW), down 5.2%. ALSO LOWER: Lpath (LPTN), down 75.6% after announcing that it will undergo corporate restructuring... Achillion Pharmaceuticals (ACHN), down 10.1% following collaboration for HCV with Janssen... El Pollo LoCo (LOCO), down 3.5% after 6M share Block Trade priced at $22.25... Cimarex Energy (XEC), down 3.3% after 6M share Spot Secondary priced at $109.00.
07:05 EDTAVEOAveo presents results of extension study 902, gets FDA feedback for tivozanib
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