BioDelivery Sciences International, Inc. (BDSI) Stock | FDA Approval Triggers $50 Million Payment

BDSI Logo. (PRNewsFoto/BioDelivery Sciences International, Inc.)

BioDelivery Sciences International, Inc.  (NASDAQ: BDSI)


BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company yesterday announced the FDA approval of BELBUCA. The FDA approval of BELBUCA has triggered a $50 million payment to BDSI from Endo, based on a license and development agreement between the two companies from 2012. BELBUCA is used for patients with chronic pain severe enough to require around the clock long term opioid treatment for which no alternate treatments are adequate. Continued success of BELBUCA may lead to more additional payments for BDSI if future sales milestones are met.  


BioDelivery Sciences International, Inc. CEO Comments

“The FDA approval of BELBUCA is a major milestone for BDSI and a tribute to the exceptional working relationship between the teams at Endo and BDSI.  I want to thank all of our employees at BDSI for achieving our third product approval,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  PR Newswire


BDSI Technical Analysis


BDSI gapped up in price yesterday to $6.08, up from the prior day’s close of $5.28, which is a 15% increase in price based on favorable news. Taking a look at the daily chart, we can see the last time the stock traded above this price level was on October 20th, when it closed at $6.49.  Taking a further look back on the chart, we can see the stock has been trending downwards since March 19th when it closed at $15.22. More recently, the stock has been on a downward swing from October 19th when it traded at $6.82. The price level of $6.80 would be the first resistance level for this spike up in price. The stock has a float of 46.54 million shares and has a short float of 28%. The stock is also trading on heavy volume, over 2.5 times the normal daily volume. The stock did reach pre market highs of $6.70, but it gave back $0.62 at the open, or equivalent to 9%. For trading purposes my entry point would have been $6.10 looking for a run through $6.50. My stop loss would have been $5.90 fearing anything below that and the stock would start to fill in the gap up.


Company Profile

BioDelivery Sciences International, Inc., a specialty pharmaceutical company, engages in the development and commercialization of pharmaceutical products principally in the areas of pain management and addiction. The company provides its products based on its patented BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, bi-layered erodible polymer film for application to the buccal mucosa. It offers ONSOLIS, a fentanyl buccal soluble film to treat breakthrough pain in opioid patients with cancer marketed under the BREAKYL name in Europe and PAINKYL name in Taiwan; BUNAVAIL, a buprenorphine and naloxone buccal film for the treatment of opioid dependence; and BELBUCA for the treatment of chronic pain. The company also develops Clonidine Topical Gel, which is in Phase III clinical trial to treat painful diabetic neuropathy and other indications; and buprenorphine depot injection. It has a licensing and development agreement with Endo Pharmaceuticals, Inc.; Arcion Therapeutics, Inc.; Evonik Corporation; and Meda AB. BioDelivery Sciences International, Inc. was founded in 1997 and is headquartered in Raleigh, North Carolina.  Yahoo Finance