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Nymox Pharmaceutical shares were shredded ($NYMX) this morning after the biotech put out word on Sunday that both late-stage studies of their lead drug flopped as a treatment for enlarged prostate. Partnered with Italy's Recordati, the biotech issued a brief statement blaming the failure on an unexpectedly high placebo response. And investors responded in premarket trading Monday by sending shares down 87%, into penny stock territory.
Nymox's deal with Recordati dates back to 2010, when the company agreed to put up a $13 million upfront to gain licensing rights to NX-1207. Over the last four years, Nymox, which is based in New Jersey, has put out a long string of releases claiming upbeat results from mid-stage tests as well as various safety and efficacy hurdles. And after the biotech admitted defeat in Phase III, the company quickly turned its sights to localized prostate cancer after reporting positive results from a Phase II test of NX-1207.
Enlarged prostates are a common issue for men as they age. Nymox had hoped that NX-1207--which is injected--would ease symptoms, which are topped by the need to urinate frequently.
Nymox has had a low profile in recent years, only rarely making its way into the headlines. Its best year was in 2010, when the company boasted of raising cash from investors as well as the Recordati deal. The biotech ended Friday with a market cap of $181 million.
"The two studies failed to meet the pre-specified efficacy endpoints. Drug safety was acceptable," noted CEO Paul Averback in a statement. "Drug efficacy reached levels similar to earlier studies but was not statistically significant in comparison to the placebo control due to a higher placebo response than in earlier NX-1207 studies and in other placebo-controlled BPH studies."
- here's the release