|Nymox CEO Paul Averback|
Late last year shares of Nymox ($NYMX) were put into the shredder after the biotech said that both of its late-stage studies for their lead drug for enlarged prostates had flopped. But the biotech rebounded today after the company claimed that an extension of those studies had produced positive results.
The general rule of thumb in biotech is that an unblinded Phase III failure is hard to get around. You can mount a new study or give up. But Hasbrouck Heights, NJ-based Nymox says that it can now go to regulators with their extension study results for fexapotide triflutate (NX-1207), and investors bought in--driving up shares by 125%
After 3.5 years, Nymox asserted, they gathered positive long-term improvements in symptoms of benign prostatic hyperplasia, fewer BPH surgeries and a good safety profile.
"The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories," Nymox said in a statement.
Nymox announced plans to take a look at the post-12-month data back in April. "Additional new blinded protocol data from the same pivotal studies is being prospectively captured in order to assess long-term results in patients up to 5 years after a single injection of NX-1207 2.5 mg vs placebo," said CEO Paul Averback at the time.
There's no word on what the FDA's position will be on "prospectively captured" data like this.
- here's the release