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KYTH > SEC Filings for KYTH > Form 8-K on 13-May-2014All Recent SEC Filings

Show all filings for KYTHERA BIOPHARMACEUTICALS INC

Form 8-K for KYTHERA BIOPHARMACEUTICALS INC


13-May-2014

Other Events


Item 8.01 Other Events.

On May 12, 2014, KYTHERA Biopharmaceuticals, Inc. issued a press release announcing that it has submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin. Positive and consistent results from two pivotal Phase III trials - REFINE-1 and REFINE-2 - were reported in late 2013 and provide the basis for the NDA submission. In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and reported significant improvement in the visual and emotional impact of treatment.


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