Nymox readies FDA filing for prostate drug
- Nymox, a New Jersey-based company specializing in diseases associated with aging, announced it will be ready to file its late-stage enlarged-prostate drug, fexapotide, in the "next one to two quarters."
- The company's stock surged on the news, adding almost 25% in late-day trading on Thursday to trade near $2.40 per share.
- Trials of fexapotide showed a low incidence of later developing prostate cancer, with only 1.3% of patients developing the disease after seven years of follow-up.
Nymox on Wednesday announced its late-stage prostate enlargement drug is now ready to be filed with the U.S. Food and Drug Administration. The filing will include data from two long-term Phase 3 studies.
Nymox said it has enough cash to handle pre-marketing activities, but will likely need a partner to handle marketing of the drug. "The drug will potentially be partnered for marketing with a larger company if satisfactory terms can be negotiated," the company said in a statement.
"While there are other companies with early stage drug candidates and/or drugs with questionable results and worrisome safety issues such as immunological reactions and common danger signs such as frequent injection related fevers, Nymox has none of these problems and considers there to be no competition for at least the next 5-10 years in this field because of the long times required to catch up to Nymox," the company added.
Although this sounds like a strong pitch to any potential partner, finding someone to help market the drug may not be so easy. The drug missed its goal in two mid-stage trials, failing to show statistically significant results.
Recent allegations from an article on the contributor website Seeking Alpha sent the stock spiraling, causing it to lose more than 40% of its value. The unsubstantiated post suggested the company was misleading investors and that its management was dumping stock.
- Nymox Statement
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