ARTICLE | Company News

Isotechnika falls on Luveniq complete response

August 5, 2010 12:29 AM UTC

Isotechnika Pharma Inc. (TSX:ISA) fell C$0.06 (28%) to C$0.16 on Wednesday after partner Lux Biosciences Inc. (Jersey City, N.J.) received a complete response letter from FDA for an NDA for Luveniq voclosporin to treat non-infectious uveitis in the intermediate or posterior segments of the eye. According to Lux, FDA said in the letter that it considers data from only one of the two pivotal trials included in the application as supportive for approval. Lux plans to begin an additional pivotal trial of Luveniq this year. ...