Why Nymox Pharma Shares Sinking to 52-Week Low?

  • Nymox Pharmaceutical Corporation NYMX has received a Refusal to File (RTF) letter from FDA regarding its marketing application for Fexapotide Triflutate.
  • Nymox's position is that clarifications remain to be resolved at a follow-up meeting and that some significant inconsistencies were involved.
  • In March, the company submitted a Fexapotide Triflutate application for benign prostatic hyperplasia (BPH).
  • The letter referred to a new outstanding issue of longer-term safety data and indicated that Nymox needed longer-term safety data.
  • Longer-term full safety data (as long as 6 years after a single low dose non-systemic injection given one time only) was not requested by the FDA in any previous pre-NDA communications.
  • Nymox will continue to seek clarification and report further material information when available.
  • Price Action: NYMX shares are down 67.5% at $0.41 during the market session on the last check Monday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In:
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!