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PGNX > SEC Filings for PGNX > Form 8-K on 11-Jun-2014All Recent SEC Filings

Show all filings for PROGENICS PHARMACEUTICALS INC

Form 8-K for PROGENICS PHARMACEUTICALS INC


11-Jun-2014

Other Events, Financial Statements and Exhibits


Item 8.01. Other Events.

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, commencing at 8:00 a.m. Eastern Time today, 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 was originally announced in June 2013 in response to the appeal by Progenics' collaboration partner, Salix Pharmaceuticals (NASDAQ:SLXP), of the FDA 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.

Briefing materials can be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm390304.htm.

A copy of the company's press release is included in this Report as Exhibit 99.1.



Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.1 Press release dated June 11, 2014.


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