Nymox Announces US NDA for Fexapotide for BPH
2018-02-05 · Nymox Corporation · original nymox.com ↗
For Further Information Contact: Erik Danielsen Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.com For Immediate Release: Nymox Announces US NDA for Fexapotide for BPH HASBROUCK HEIGHTS, NJ (February 5, 2018) Nymo x Pharmaceutical Corporation (NASDAQ: NYMX) announced today that the Company will submit a New Dr ug 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 tr ial 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 [email protected] or 800-936-9669. Forward Looking Statements To the extent that statements contained in this press rel ease are not descriptions of historical facts regarding Nymox, they ar e forward-looking statements reflecting t he current beliefs and expectations of mana gement made pursuant to the safe harbor provisions of the Private Secu rities Litigation Reform Act of 1995, including st atements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to tr eat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements invo lve substantial risks and uncert ainties 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 clinic al drug development process, including the r egulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on Fexapot ide, Nymox's commercialization plans and effort s 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 ac tual results to differ from those expressed in these forward-looking statem ents, 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. NEWS RELEASE
The release as fetched from its publisher. nymox.com ↗