Shares of Auxilium Pharmaceuticals (NASDAQ:AUXL) climbed nearly 10% Monday after the specialty drug maker reported positive trial results from an experimental treatment for penile dysfunction.
Peyronie’s disease, commonly known as PD, is a physically and potentially emotionally devastating disorder in men that can result in varying degrees of penile curvature deformity.
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If approved by the U.S. Food and Drug Administration, Xiaflex is expected to be the first and only approved-biologic-therapy for the treatment of PD.
Other common treatments, such as oral, topical and injection therapies, are non-FDA-approved and not based on rigorous scientific data, Auxilium said. As of now, surgery is typically a last resort treatment, as it often carries a large risk of complications, including decreased penile length or erectile dysfunction.
The Malvern, Pa.-based company said the drug, Xiaflex, met statistically significant endpoints in two 52-week studies.
In the first, the drug reported a 37.6% mean reduction in penile curvature deformity and a 44% improvement in disease bother. In the second, deformity reduced by 30.5%, while bother improved by 32.4%.
The drug was generally well-tolerated, with the only adverse events related to pain and swelling at the injection site, Auxilium said.
“We believe that Xiaflex, if approved for the treatment of Peyronie's Disease, has the clinical profile to become a potential breakthrough procedure," Auxilium chief executive, Adrian Adams, said in a statement.
Reflecting Auxilium's view that Xiaflex could be a pipeline drug with “potential applications in multiple therapeutic areas that currently have limited options,” brokerage RBC raised its price target on Auxilium to $28 from $26 on an “outperform” rating.
Shares were up as high as 22% to $23 premarket but have since fallen to $20.39.