NPS jumps on positive Gattex briefing documents

NPS Pharmaceuticals Inc. (NASDAQ:NPSP) jumped $1.73 (19%) to $10.86 on Friday after FDA reviewers said they are in "general agreement" with the company's analysis that Gattex teduglutide is an effective treatment for short bowel syndrome (SBS). The reviewers did identify three serious safety risks -- gastrointestinal obstructions; biliary and pancreatic disorders; and acceleration of neoplastic and enhancement of colon polyp growth -- but concluded that the concerns were not sufficient to restrict access to the product. Reviewers endorsed NPS's proposed REMS that would require prospective Gattex patients to be cancer-free for five years. The comments came in briefing documents released ahead of Tuesday's FDA's Gastrointestinal Drugs Advisory Committee meeting to discuss an NDA for the analog of glucagon-like peptide-2 (GLP-2). The PDUFA date is Dec. 30.

The reviewers agreed with NPS's analysis that Gattex significantly reduced the proportion of patients achieving a 20% or greater reduction in weekly parenteral nutrition volume from baseline to weeks 20 and 24, the primary endpoint, vs. placebo in Phase III testing. According to the documents, the committee will discuss at Tuesday's meeting whether this endpoint is clinically meaningful, but the reviewers noted that EMA's CHMP had already "concluded that reduction in parenteral fluid requirements was clinically meaningful." ...