AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX)
California based drug company, AcelRx, announced today that their drug Zalviso was given a positive opinion by CHMP (Committee for Medicinal Products for Human Use of the European Medicines Agency). Zalviso is alleviates moderate to severe postoperative pain in adult patients. PR Newswire
ACRX Earnings & Outlook
AcelRx’s European licensee, Gruenthal Group, submitted the Marketing Authorization Application (MAA) under the centralized procedure. Gruenthal expects Zalviso to launch in the beginning half of 2016. If this happens, ACRX would be eligible to receive a $15 million milestone. Once Zalviso receives approval after all trial runs, Gruenthal will be responsible for maintaining device regulatory approval in their territory.
AcelRX Pharmaceuticals CEO’s Comments
“We believe that Zalviso represents a significant advancement in the management of acute pain, including the moderate-to-severe acute pain experienced by patients recovering from surgery. With this positive opinion from CHMP, Grunenthal and AcelRx are one step closer to bringing a non-invasive, self-dosing, pain management system to the estimated 15.7 million Europeans who undergo surgeries associated with moderate-to-severe post-operative pain every year,” stated Howie Rosen interim chief executive officer of AcelRx Pharmaceuticals. “We appreciate the collaborative approach of the CHMP and look forward to continued collaboration with EMA to complete the regulatory process.” Yahoo Finance
ACRX gapped up in price to $4.90 up from yesterday’s close of $4.42 which is a 11% increase based on favorable news. Taking a look at the daily chart we can see the gap up in price went thru recent high of $4.75 reached on April 17 and April 23 where it formed a double top. After forming the double top the stock reached lows of $2.96 on May 5th. Going back a little further we can see the stock was at highs of $9.24 on March 4th. As we can see the stock has been very volatile in the past 6 months as pharmaceutical stocks can be very sensitive to news based on their drug trials. The stock has a low float of $24.7 million shares and a high short float of 32.80%, meaning the stock can move up quickly as shorts may be looking to cover their positions. Making this stock a prime candidate for a gap and go strategy. However I would proceed with caution as pharmaceuticals can be very volatile and have tight stops on any position taken.
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, develops and commercializes therapies for the treatment of acute pain. The companys lead product candidate is Zalviso, an investigational, pre-programmed, non-invasive, handheld system that has completed Phase III clinical trials for the treatment of moderate-to-severe acute pain in the hospital setting. The company is also developing ARX-04, a sufentanil single-dose tablet, which has been planned to initiate Phase III clinical trials for the treatment of moderate-to-severe acute pain to be administered by a healthcare professional to a patient in settings of acute pain, such as in the emergency room, hospital floor, ambulatory care facilities, or on the battlefield. In addition, its product candidate pipeline consists of ARX-02, a pain management system that has completed Phase II clinical trials for the treatment of cancer patients who suffer from breakthrough pain; and ARX-03, a single, fixed-dose, and combination drug product, which has been completed Phase II clinical trial designed to provide mild sedation, anxiety reduction, and pain relief for patients undergoing painful procedures in a physicians office. The company was formerly known as SuRx, Inc. and changed its name to AcelRx Pharmaceuticals, Inc. in August 2006. AcelRx Pharmaceuticals, Inc. was founded in 2005 and is headquartered in Redwood City, California. Yahoo Finance