0000835887-15-000012.txt : 20150302 0000835887-15-000012.hdr.sgml : 20150302 20150302171318 ACCESSION NUMBER: 0000835887-15-000012 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150302 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150302 DATE AS OF CHANGE: 20150302 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PROGENICS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000835887 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133379479 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23143 FILM NUMBER: 15665828 BUSINESS ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 BUSINESS PHONE: 9147892800 MAIL ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 8-K 1 form8_k2mar2014.htm FORM 8-K
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 2, 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))
 


Item 8.01.
Other Events.

Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announced today that long-term follow-up data from its ongoing pivotal Phase 2 Study of AzedraTM in patients with pheochromocytoma and paraganglioma will be presented at the Endocrine Society's 97th Annual Meeting, taking place from March 5-8, 2015 in San Diego, California.
 
 
A copy of Progenics' press release is included in this Report as Exhibit 99.1.
  
Item 9.01.
Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit No.
Description
 
 


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/ ANGELO W. LOVALLO, JR.
   
Angelo W. Lovallo, Jr.
   
Vice President - Finance & Treasurer
   
(Principal Financial and Accounting Officer)

 
 
Date: March 2, 2015


EX-99.1 2 ex99_12mar2014.htm EXHIBIT 99.1
Exhibit 99.1

 
 
 
 
 


Progenics Pharmaceuticals Announces Presentation at ENDO 2015

TARRYTOWN, N.Y., March 2, 2015 – Progenics Pharmaceuticals, Inc., (Nasdaq: PGNX) announced today that long-term follow-up data from its ongoing pivotal Phase 2 Study of AzedraTM in patients with pheochromocytoma and paraganglioma will be presented at the Endocrine Society's 97th Annual Meeting, taking place from March 5-8, 2015 in San Diego, California. 

The details of the oral presentation are included below:

Date and Time: March 7th at 12:45 p.m.
Title: Long Term Follow-up of a Pivotal Phase 2 Study of Ultratrace® Iobenguane I-131 (Azedra) in Patients with Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Session: OR24 - Adrenal Tumors: Clinical Implications of the Recent Molecular and Genetic Findings Bench to Bedside
Location: Room 6B (San Diego Convention Center)

About Azedra

Azedra is a radio-therapeutic with FDA Fast Track status currently being studied in a phase 2 registrational trial under a Special Protocol Assessment with the U.S. Food and Drug Administration using a surrogate marker registrational endpoint. In addition to potentially treating pheochromocytoma and paraganglioma, Azedra may also have utility in treating neuroblastoma and other neuroendocrine diseases.

About Pheochromocytoma and Paragangliomas

Pheochromocytomas and paragangliomas are rare neuroendocrine tumors that arise from cells of the sympathetic nervous system. When pheochromocytomas are located outside the adrenal glands, they are called paragangliomas. Standard treatment options for these tumors include surgery, palliative therapy and symptom management. Malignant and recurrent pheochromocytomas and paragangliomas may result in unresectable disease with a poor prognosis, representing a significant management challenge with very limited treatment options and no approved anti-tumor therapies.


Page 2
About Progenics

Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in later-stage clinical development. Progenics' first-in-class PSMA-targeted technology platform for prostate cancer includes an antibody drug conjugate therapeutic which completed a two-cohort phase 2 clinical trial and a small molecule imaging agent that has also completed a phase 2 trial. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate currently in a phase 2 study under an SPA. Progenics' first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. For additional information, please visit www.progenics.com.       

This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this press release as of its date and does not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise.

Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release. For more information, please visit www.progenics.com. Please follow us on LinkedIn®.

Information on or accessed through our website or social media sites is not included in the company's SEC filings.

(PGNX-F)
 
Contact:  
 
Melissa Downs
 
 
Investor Relations
 
 
(914) 789-2801
 
 
mdowns@progenics.com

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