Nymox Reports Pre-NDA CMC Meeting with the FDA
April 16 2019 - 12:46PM
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) today announced
that it has held its pre-New Drug Application (NDA) Chemistry
Manufacturing and Controls (CMC) meeting with the US Food and Drug
Administration (FDA) regarding its lead product candidate
Fexapotide Triflutate, a novel prostate injectable developed for
the treatment of enlarged prostate (Benign Prostatic Hyperplasia,
BPH). The purpose of the April 15 meeting was to discuss the CMC
data package for Fexapotide, an important regulatory requirement
prior to the NDA submission. Nymox is pleased to report that it
considers the meeting was constructive and positive. The
authorities did not raise any serious or unexpected issues with
regard to Nymox’s CMC data package, which was submitted prior to
the meeting.
Mark Staples, Nymox’s VP of Chemistry,
Manufacturing and Controls, commented: “We are pleased with the
outcome of this important meeting and the feedback we got from the
Agency. We believe that the Chemistry, Manufacturing, and Quality
Control sections of our NDA filing in the U.S. will provide the
technical knowledge base required to fully meet the safety and
performance expectations for a commercial therapeutic product. We
recognize the fundamental importance of the CMC contribution to an
NDA filing and, therefore, consider this meeting an important
milestone in our efforts towards successful filing of the NDA for
Fexapotide for BPH in the U.S. later this year.”
For more information please
contact info@nymox.com or 800-936-9669.
Forward Looking Statements
To the extent that statements contained in this
press release are not descriptions of historical facts regarding
Nymox, they are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995, including statements regarding the need for new options to
treat BPH and prostate cancer, the potential of Fexapotide to treat
BPH and prostate cancer and the estimated timing of further
developments for Fexapotide. Such forward-looking statements
involve substantial risks and uncertainties that could cause our
clinical development program, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the clinical drug development process, including the regulatory
approval process, the timing of Nymox's regulatory filings, Nymox's
substantial dependence on Fexapotide, Nymox's commercialization
plans and efforts and other matters that could affect the
availability or commercial potential of Fexapotide. Nymox
undertakes no obligation to update or revise any forward looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of Nymox in general, see Nymox's current
and future reports filed with the U.S. Securities and Exchange
Commission, including its Annual Report on Form 20-F for the year
ended December 31, 2018, and its Quarterly Reports.
For Further Information Contact:Erik
DanielsenNymox Pharmaceutical
Corporation1-800-93NYMOXwww.nymox.com
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