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Nymox Announces US NDA for Fexapotide for BPH

HASBROUCK HEIGHTS, N.J., Feb. 05, 2018 (GLOBE NEWSWIRE) -- 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

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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 Danielsen
Nymox Pharmaceutical Corporation