Drug Development

Under the gun, Nymox sparks another rally with a new batch of follow-up BPH data

More than a year ago, Nymox Pharmaceutical managed to whip up a big rally for its battered stock $NYMX after claiming an unexpected turnaround for its lead drug fexapotide for treating an enlarged prostate. A pair of late-stage failures — which shredded its stock — had been overcome with positive data from an extension of the trial, execs said.

The next step, company CEO Paul Averback assured investors, would be to trek to regulators for a discussion about filing for an approval on the drug.

And that was just about the last I heard about it, until today. Now Nymox says that it has even better extension data on hand from patients crossing over from a placebo group. And those regulatory filings?

“The Company expects to file for approvals in the next 1-2 quarters,” Nymox said in a statement today.

Nymox’s stock shot up 34% Wednesday afternoon, but still hasn’t returned to the old highs set just before it announced the late-stage failure in late 2014. After the biotech’s claimed turnaround last year, it shifted its domicile to The Bahamas.

Nymox was the subject of a bitter short attack earlier in the month, which drove its shares into the tank yet again on claims that the company was misleading investors about its drug and its prospects. In a filing with the SEC, the company stated that it had “approximately $374,463 and a working capital deficiency of $1,559,132” at the end of 2015. Then a week ago, the company raised $2.24 million in a private placement. The 21-year-old biotech has burned through more than $118 million.

Investors today were reacting to a new data release which purported to show that there was a steep drop in the need for follow-up surgery for the crossover group who received the drug, compared to other placebo patients who received the standard of care.

“These prospective study results in blinded placebo crossover patients clearly demonstrate that fexapotide reduces the long-term need for surgery by 82-95% compared to approved conventional BPH treatments”, said Averback in a statement. “Fexapotide shows significant efficacy against prostate cancer as a therapeutic, and in addition has been shown to reduce the risk of prostate cancer when fexapotide is used to treat BPH. This is in stark contrast to some conventional BPH treatments in routine clinical use today which on the other hand increase prostate cancer risk, and which have many other well known undesirable side effects.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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