Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) Files An 8-K Other EventsItem 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.
PROGENICS PHARMACEUTICALS INC ExhibitEX-99.1 2 ex_108689.htm EXHIBIT 99.1 ex_108689.htm Exhibit 99.1 Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) New York,…To view the full exhibit click here
About Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX)
Progenics Pharmaceuticals, Inc. is engaged in developing medicines and other products for targeting and treating cancer. The Company’s products in development include therapeutic agents designed to target cancer and imaging agents, which focuses on enabling clinicians and patients to accurately visualize and manage their diseases. The Company’s EXINI Bone BSI is an analytical tool that employs an artificial intelligence-based approach to apply techniques of statistical analysis and pattern recognition to quantify the information produced by bone scintigraphy (bone scan) images used to view cancer present in the skeleton. The EXINI Bone BSI tool reads bone scans and produces an automated Bone Scan Index quantification. The Company’s clinical-stage products include AZEDRA, 1404 (trofolastat), PyL ([18F] DCFPyL), 1095 and PSMA ADC. The Company’s partnered products include Relistor-Subcutaneous injection, Relistor-Oral Tablets and PRO 140.