prog20180322_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) March 22, 2018

 

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 8.01.     Other Events.

 

On March 22, 2018, Progenics Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has extended the Prescription Drug User Fee Act (“PDUFA”) date for its review of the AZEDRA® (iobenguane I 131) new drug application by three months to July 30, 2018. The FDA extended the action date to allow for a full review of the Company’s responses to recent information requests from the FDA.

 

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 announcing three-month extension of PDUFA date for AZEDRA® (iobenguane I 131), dated March 22, 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: March 22, 2018