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TARRYTOWN, N.Y., June 11, 2014 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that NASDAQ has halted trading of the company's common stock.
The U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee is meeting today and tomorrow, June 11 and 12, to discuss the potential cardiovascular risk associated with products in the class of peripherally-acting opioid receptor antagonists and the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain.
The Advisory Committee meeting is scheduled for 8:00 a.m. Eastern Time today. The briefing materials can be found on the FDA website at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm390304.htm. The Advisory Committee was originally announced in June 2013 in response to the appeal by Progenics' collaboration partner, Salix Pharmaceuticals (Nasdaq:SLXP), of the U.S. Food and Drug Administration's July 2012 Complete Response Letter in respect of Salix's supplemental New Drug Application for Relistor
® subcutaneous injection for treatment of opioid-induced constipation in patients with chronic non-cancer pain. The FDA has stated that it will take action under the appeal within 30 days after receiving input from the Committee.
For more information concerning the Advisory Committee, please see
Item 1 – Business – Relistor in the Company's 2013 Annual Report on Form 10-K and its first quarter 2014 Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission, as well as information disseminated by the FDA and/or available on its website.
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Salix Pharmaceuticals, Ltd. Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness.