FDA posts briefing papers for review of NPS Pharma's Gattex for SBS
The USA Food and Drug Administration has posted briefing materials for the October 16 Gastrointestinal Drugs Advisory Committee meeting to review USA-based NPS Pharmaceuticals’ (Nasdaq: NPSP) 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 (SBS).
NPS saw its shares leap almost 19% to $10.85 in morning trading Friday, after FDA staffers indicated that a very positive overall assessment of Gattex, seeming to back the approval of the drug. The stock is up 65% for the year.
In the briefing papers, the FDA asks that the Committee to:
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