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) April 24, 2015
Progenics Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | | 000-23143 | | 13-3379479 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
| | | | | |
| 777 Old Saw Mill River Road, Tarrytown, New York | | 10591 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant's telephone number, including area code (914) 789-2800 |
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 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a new indication for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for the treatment of opioid-induced constipation (OIC) when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older. Additionally, the Committee has recommended a one-year extension of data/marketing protection for RELISTOR, to 11 years from the date of approval, citing the fact that RELISTOR offers a major contribution to patient care in comparison to existing therapies.
A copy of the companies' joint press release is included in this Report as Exhibit 99.1.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
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.
| | PROGENICS PHARMACEUTICALS, INC. |
| | By: | /s/ ANGELO W. LOVALLO, JR. |
| | | Angelo W. Lovallo, Jr. |
| | | Vice President - Finance & Treasurer |
| | | (Principal Financial and Accounting Officer) |
Date: April 24, 2015
