Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131)
March 22 2018 - 4:15PM
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company
developing innovative medicines and imaging analysis technology for
targeting and treating cancer, announced today that the
Company has received notification from the U.S. Food and Drug
Administration (FDA) that the Agency will extend its review of the
New Drug Application (NDA) for AZEDRA® (iobenguane I 131) by three
months to July 30, 2018.
The extension is the result of the submission of
additional Chemistry, Manufacturing, and Controls (CMC) information
by Progenics, which required additional time for FDA review. The
standard three-month extension is not related to the efficacy or
safety data of AZEDRA.
“We remain confident in our NDA submission and
are committed to bringing AZEDRA forward as an option for patients
with malignant pheo and para,” said Mark Baker, Chief
Executive Officer of Progenics. “We look forward to continuing our
dialogue with the Agency as we prepare for a potential approval of
AZEDRA.”
About Progenics
Progenics develops innovative medicines and
other technologies to target and treat cancer. Progenics' pipeline
includes: 1) therapeutic agents designed to precisely target cancer
(AZEDRA®, 1095, and PSMA TTC), 2) PSMA-targeted imaging agents for
prostate cancer (1404 and PyL™), and 3) imaging analysis
technology. Progenics' first commercial product, RELISTOR®
(methylnaltrexone bromide) for opioid-induced constipation, is
partnered with Valeant Pharmaceuticals International, Inc.
This press release may contain projections and
other "forward-looking statements" regarding future events.
Statements contained in this communication that refer to Progenics'
estimated or anticipated future results or other non-historical
facts are forward-looking statements that reflect Progenics'
current perspective of existing trends and information as of the
date of this communication. Forward looking statements generally
will be accompanied by words such as "anticipate," "believe,"
"plan," "could," "should," "estimate," "expect," "forecast,"
"outlook," "guidance," "intend," "may," "might," "will,"
"possible," "potential," "predict," "project," or other similar
words, phrases or expressions. 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
unpredictability of results of clinical trials and other
development activities and collaborations; the unpredictability of
the duration and results of regulatory review of New Drug
Applications (NDA) and Investigational NDAs, including our NDA for
AZEDRA; market acceptance for approved products; possible product
safety or efficacy concerns, general business, financial,
regulatory 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,
including those risk factors included in its Annual Report on
Form 10-K for the annual period ended December 31, 2017.
Progenics is providing the information in this press release as of
its date and, except as expressly required by law, Progenics
disclaims any intent or obligation to update or revise any
forward-looking statements, 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. Information on or
accessed through our website or social media sites is not included
in the company's SEC filings.
(PGNX-F)
Contact:Melissa DownsInvestor
Relations(646) 975-2533mdowns@progenics.com
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