Nymox tanks as FDA rejects NDA for fexapotide

California, USA-based biotech Nymox Pharmaceutical (Nasdaq: NYMX) saw its shares plunge as much as 64% yesterday, after it said it has received a Refusal to File (RTF) letter from the Food and Drug Administration on regarding the company's New Drug Application (NDA) for fexapotide triflutate, its candidate for the treatment of benign hyperplasia (BPH).

Nymox’ position is that clarifications remain to be resolved at a follow-up meeting and that some significant inconsistencies were involved.

The letter referred to a new outstanding issue of longer-term safety data and indicated that Nymox needed to have longer-term safety data in its NDA. Longer-term full safety data (as long as six 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.