NYMX - Nymox gets FDA feedback on NDA resubmission for lead asset

• Nymox Pharmaceutical ( NASDAQ: NYMX ), a biotech focused on drugs for the elderly, announced Tuesday that during the recent interactions, the FDA specified what additional information is required to resubmit a marketing application for its lead candidate Fexapotide.
• The company added that it is preparing the requested documentation in anticipation of the resubmission and looks forward to additional regulatory guidance from the FDA.
• In addition, NYMX announced plans to submit regulatory filings for Fexapotide in Q4 to seek European approval for the injection.
• Fexapotide Triflutate, also known as NX-1207, has undergone clinical studies for prostate-linked indications, including a Phase 3 trial for benign prostatic hyperplasia (BPH).
• However, in May, the company said that the FDA rejected to review the company’s marketing application for the drug in BPH.

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