prog20180103_8k.htm

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) December 29, 2017

 

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.)

         

 

    One World Trade Center, New York, New York

10007

(Address of principal executive offices)

(Zip Code)

Registrant's telephone number, including area code         (646) 975-2500

            

 

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):

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

Item 7.01.     Regulation FD Disclosure.

 

On December 29, 2017, Progenics Pharmaceuticals, Inc. (“Progenics” or the “Company”) issued a press release announcing the acceptance of the New Drug Application (“NDA”) for AZEDRA® (iobenguane I 131) by the U.S. Food and Drug Administration (“FDA”). On January 2, 2018, Progenics issued a press release announcing the completion of patient enrollment in the Company’s Phase 3 clinical study of PSMA-targeted imaging agent 1404. A copy of each of the foregoing press releases is furnished as, respectively, Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and each is incorporated in this Item 7.01 by reference.

 

The information in this Item 7.01 and Exhibits 99.1 and 99.2 of this Current Report on Form 8-K is furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 and Exhibits 99.1 and 99.2 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in any such filing.

 

 

Item 9.01.

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

Description

 

99.1

Press Release announcing acceptance of the NDA filing for AZEDRA by the FDA, dated December 29, 2017

99.2

Press Release announcing completion of enrollment in Phase 3 study of 1404, dated January 2, 2018

 

 

 

 

SIGNATURES

 

 

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/ Patrick Fabbio

   

Patrick Fabbio

   

Senior Vice President and Chief Financial Officer

   

(Principal Financial and Accounting Officer)

 

 

 

Date: January 3, 2018