- 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.
For further details see:
Nymox gets FDA feedback on NDA resubmission for lead asset