NPS Pharmaceuticals, Inc. Stock Trading Halted Today; FDA Advisory Committee to Review Natpara Biologics License Application
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that NASDAQ has halted trading of the company's common stock. The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) is meeting today to review the company's Biologics License Application (BLA) for Natpara® (rhPTH [1-84]). Natpara is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH) that NPS Pharma has developed for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of PTH.
The Advisory Committee meeting is scheduled for 8:00 a.m. EDT and is scheduled to end at 5:00 p.m EDT. The FDA briefing materials for the meeting can be found at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm386727.htm.
EMDAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders and makes appropriate recommendations to the FDA. The committee's recommendation will be considered by the FDA in its review of the company's BLA for Natpara. The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the Natpara BLA is October 24, 2014.
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