UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) October 1, 2013
Progenics Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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000-23143
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13-3379479
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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777 Old Saw Mill River Road, Tarrytown, New York
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10591
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(Address of principal executive offices)
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(Zip Code)
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Registrant's telephone number, including area code (914) 789-2800
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) and Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) have announced that the U.S. Food and Drug Administration will convene on March 10-11, 2014 the Advisory Committee reported by the companies earlier this year to consider Salix's Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for opioid-induced constipation in patients with chronic pain. The date and agenda for the Advisory Committee will not be definitive until publication in the Federal Register.
A copy of the companies' press release is included in this Report as Exhibit 99.1.
Progenics is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics' first-in-class PSMA targeted technology platform includes an antibody-drug conjugate therapeutic and a small molecule targeted imaging agent, both in Phase 2 clinical trials. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is AzedraTM, an ultra-orphan radiotherapy candidate also in phase 2 under an SPA. Progenics' first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. Ono Pharmaceutical Co. is developing Relistor in Japan. For additional information, please visit www.progenics.com.
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Item 9.01.
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Financial Statements and Exhibits.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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PROGENICS PHARMACEUTICALS, INC.
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By:
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/s/ ANGELO W. LOVALLO, JR.
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Angelo W. Lovallo, Jr.
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Vice President, Finance & Treasurer
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(Principal Financial and Accounting Officer)
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Date: October 2, 2013