NYMX - NYMOX down 46% on Refuse to File letter from FDA for fexapotide for enlarged prostate

Shares of NYMOX Pharmaceutical (NASDAQ:NYMX) have plummeted 46% after the company received a Refuse to File letter from the U.S. FDA for its New Drug Application for fexapotide triflutate for benign prostate hyperplasia. The letter said that the company needs longer-term safety data. NYMOX (NYMX) noted that longer-term safety data -- as long as six years after a single dose -- was not mentioned by the agency in any prior communication before submission of the NDA. NYMOX (NYMX) said it included safety data from two to three years after the single injection as part of its NDA package and there were no indications of any long-term safety concerns in its pivotal trial. The company added that "clarifications remain to be resolved at a follow-up meeting and that some significant inconsistencies were involved."

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NYMOX down 46% on Refuse to File letter from FDA for fexapotide for enlarged prostate