Nymox Announces US NDA for Fexapotide for BPH
February 05 2018 - 11:15AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today that
the Company will submit a New Drug Application (NDA) for Fexapotide
Triflutate for the treatment of BPH in the US. The Company has
recently had a pre-NDA meeting with FDA. The NDA will be submitted
by the Company later this year. The Company further states again
that there can be no assurances about the timelines or outcomes of
any submission and that no forward looking statements will be made.
The full results of the Company's Phase 3 US
trials were recently published in World Journal of Urology. World
Journal of Urology is the Official Journal of the Urological
Research Society and is also the Official Journal of the
International Society of Urology. The article's lead author was Dr.
Neal Shore, along with 16 co-authors consisting of prominent
clinical trial urologist-investigators from across the US. The peer
review article is entitled "Fexapotide Triflutate: Results of
Long-Term Safety and Efficacy Trials of a Novel Injectable Therapy
for Symptomatic Prostate Enlargement". The article is available at
https://doi.org/10.1007/s00345-018-2185-y.
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, 2016, and its Quarterly Reports.
For Further Information
Contact:Erik DanielsenNymox Pharmaceutical
Corporation1-800-93NYMOXwww.nymox.com
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