Sophiris Bio, Inc. (SPHS) Stock | Positive Phase 3 Study Results


Sophiris Bio, Inc. (NASDAQ: SPHS)


Sophiris Bio, Inc. (SPHS), a clinical stage biopharmaceutical company yesterday announced its phase 3 study of PRX302 has met its primary endpoints. PRX302 is used for the treatment of urinary tract symptoms, and enlarged prostate. The study showed statistically significant improvement compared to the control group.


Sophiris Bio, Inc. CEO Comments

“The combination of the efficacy and safety profile makes PRX302 a particularly compelling potential option for men suffering from BPH and may help men avoid more invasive, surgical procedures,” said Randall Woods, President and CEO of Sophiris. “PRX302 is the only single-administration investigational treatment for BPH that has demonstrated a statistically significant improvement in symptoms of BPH, is well-tolerated, and has a favorable safety profile. The results of the study demonstrate clear biological activity of PRX302 and increase our confidence in the mechanism of action.”  PR Newswire

Chief Operating Officer Comments :

“A 7.60 point improvement in IPSS total score over 12 months indicates that patients are experiencing a significant relief of their BPH symptoms and improvement in their quality of life following a single treatment with PRX302,” said Dr. Allison Hulme, chief operating officer and head of research and development at Sophiris Bio. “Oral medications such as alpha blockers and 5-alpha reductase inhibitors typically demonstrate a 3-6 point improvement in IPSS total score. We believe that a statistically significant improvement in IPSS, if replicated in a second Phase 3 trial, may be sufficient for registration with the FDA.”  PR Newswire


SPHS Technical Analysis


SPHS gapped up in price yesterday to $3.28, up from the prior day’s close of $0.86, which is a 281% increase on the favorable news. Taking a look at the daily chart, we can see the last time SPHS traded above this price level was on September 11th, 2014, when it closed at $3.30.  Examining the daily chart we can see the previous 52 week high was $3.12 which was reached on December 2nd, 2014. Most stocks tend to pop through the 52 week highs so I will be looking to go long and try to catch the move. SPHS has a low float of 14.19 million shares and traded  over 61 times the normal daily trading volume. Both of these factors make SPHS a great candidate for the gap and go strategy. SPHS did reach pre market highs of $4.29, but gave back $1.01 at the open, or equivalent to 24%. For trading purposes, my entry point would have been $3.35 looking for a run up to $4. My stop loss would have been $3.20, fearing anything below that and the stock would start to fill in the gap up.


Company Profile

Sophiris Bio, Inc., a clinical-stage biopharmaceutical company, focuses on the development of products for the treatment of urological diseases. The company’s primary product candidate is PRX302, which is in Phase III clinical trial for treatment for the symptoms of benign prostatic hyperplasia (BPH), as well as for the treatment of localized low to intermediate risk prostate cancer. It has a strategic relationship with Kissei Pharmaceutical Co., Ltd. for the development and commercialization of PRX302 and other products for the treatment of the symptoms of BPH, prostate cancer, prostatitis, or other diseases of the prostate; and license agreement with UVIC Industry Partnerships Inc. and The Johns Hopkins University with respect to the use of PRX302 for the development of therapeutics for the symptoms of BPH, prostate cancer, and other non-cancer diseases and conditions of the prostate. The company was formerly known as Protox Therapeutics Inc. and changed its name to Sophiris Bio, Inc. in April 2012. Sophiris Bio, Inc. was founded in 2002 and is based in La Jolla, California.  Yahoo Finance