8-K 1 prog20190619_8k.htm FORM 8-K prog20190619_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): June 20, 2019 

 


 

Progenics Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-23143

 

13-3379479

(State or other jurisdiction
of incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

One World Trade Center, 47th Floor, New York, New York 10007

 (Address of Principal Executive Offices)                     (Zip Code)

 

 

 

 

 

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

 

Not Applicable

(Former name or former address, if changed since last report)


 

Securities registered pursuant to Section 12(b) of the Act:

 

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:

 

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))

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0013

PGNX

The Nasdaq Global Select Market

 

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 June 20, 2019, Progenics Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that, following a Type B meeting with the U.S. Food and Drug Administration, the Company plans to conduct a basket study that will evaluate AZEDRA in patients with unresectable or metastatic neuroendocrine tumors (NETs) who are MIBG avid, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and other NETs, with a dosing regimen that potentially enables outpatient administration. The basket study is expected to enroll approximately 120 patients at sites in the U.S. and the Company plans to initiate the study by the end of 2019. A copy of the foregoing press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated in this Item 7.01 by reference.

 

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01             Financial Statements and Exhibits

 

(d)         Exhibits.

 

     

Exhibit

No.

 

Description

   

99.1

 

Press Release announcing plans to initiate a basket trial to support an expanded label for AZEDRA® (iobenguane I 131), dated June 20, 2019

 

 

 

 

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

   

Executive Vice President and Chief Financial Officer

   

(Principal Financial and Accounting Officer)

 

 

Date: June 20, 2019