La Jolla-based Sophiris Bio Inc. announced Tuesday that its sole drug in development met the main goal of a late-stage study. The results have revived hopes for market approval nearly a year after the company's interim analysis suggested the treatment would fail the study.
Sophiris's (Nasdaq: SPHS) stock, which has traded as low as 42 cents this year, more than doubled after the news and is currently trading at $2.80 per share.
The company said the drug, PRX302, had significantly improved symptoms in men suffering from benign prostatic hyperplasia, or enlarged prostate. The drug was well-tolerated and did not cause any serious health concerns, Sophiris said.
Sophiris has said the treatment has "blockbuster" potential ― meaning annual sales of more than $1 billion.
According to the Urology Care Foundation, enlarged prostate affects about half of men in their 50s and up to 90 percent of men older than 80.
Replicating the latest results for PRX302 in another late-stage study may be enough to apply to the U.S. Food and Drug Administration for marketing approval, the company stated.