Nymox Announces US NDA for Fexapotide for BPH

On February 5, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that the Company will submit a New Drug Application (NDA) for Fexapotide Triflutate for the treatment of BPH in the US (Press release, Nymox, FEB 5, 2018, View Source [SID1234523738]). 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.

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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 View Source

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