Ul­tragenyx nix­es plan to seek quick OK for rare dis­ease drug in Eu­rope

Faced with a push­back from Eu­ro­pean reg­u­la­tors, Ul­tragenyx to­day says that it is jerk­ing its ap­pli­ca­tion for a con­di­tion­al ap­proval of its drug for GNE My­opa­thy.

Ul­tragenyx had hoped to score an ear­ly OK on Phase II da­ta for Aceneu­ram­ic Acid Pro­longed Re­lease (Ace-ER). But reg­u­la­tors shook their heads on that idea. Now the No­va­to, CA-based rare dis­ease spe­cial­ist says it plans to re­group and go at this again with late-stage da­ta in H2 2017.

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