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NPS Pharmaceuticals, Inc. (NPSP), a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that the U.S. Food and Drug Administration (FDA) has posted briefing materials for the October 16, 2012 Gastrointestinal Drugs Advisory Committee meeting to review Gattex® (teduglutide). Gattex is a novel, recombinant analog of human glucagon-like peptide 2 (a protein involved in the rehabilitation of the intestinal lining) being developed for the treatment of adults with short bowel syndrome.
The Advisory Committee meeting is scheduled for 8:00 a.m. ET on Tuesday, October 16, 2012. The briefing materials can be found on the FDA website athttp://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm291609.htm. The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the company’s New Drug Application (NDA) for Gattex is December 30, 2012.
The Gastrointestinal Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases and makes appropriate recommendations to the FDA.