Company Update (NASDAQ:BDSI): Why BioDelivery Sciences International, Inc. Shares Are on the Ropes Today

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) and Endo International (NASDAQ:ENDP) announced this morning that Clonidine Topical Gel failed to meet its primary endpoint in a Phase 2b in painful diabetic neuropathy and that development will be discontinued.

BioDelivery shares reacted to the news, falling 8% in early trading Tuesday.

“We clearly indicated when we embarked on this study that following the changes we made to the protocol based on previous work, that the results would support a definitive decision,” said Dr. Mark A. Sirgo, President and Chief Executive Officer.  “We can comfortably say that the changes made to the protocol design provided us with a reliable and unambiguous data set that demonstrated that Clonidine Topical Gel, at this strength and in this delivery form, is not effective for the treatment of painful diabetic neuropathy.  As such, we have no further plans for development at this time, and the $16 million that was to be directed to this program for 2017 will now allow us to extend our cash runway into fourth quarter of next year.”

Dr. Sirgo continued, “We will focus our R&D efforts on two important and exciting programs for our buprenorphine 30-day injection product in development – opioid dependence and chronic pain.  Both are areas complimentary to BELBUCA and BUNAVAIL, where buprenorphine efficacy has previously been established with other products, and BDSI has considerable clinical expertise and regulatory experience with FDA.”

On the ratings front, Biodelivery has been the subject of a number of recent research reports. In a report issued on December 9, Cantor analyst Chiara Russo reiterated a Hold rating on BDSI, with a price target of $3.00, which represents a potential upside of 50% from where the stock is currently trading. Separately, on December 8, FBR’s Edward White reiterated a Buy rating on the stock and has a price target of $8.00.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chiara Russo and Edward White have a yearly average return of 0.5% and a loss of 10.2% respectively. Russo has a success rate of 49% and is ranked #2159 out of 4269 analysts, while White has a success rate of 21% and is ranked #4145.

Sentiment on the street is mostly bullish on BDSI stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock.

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that engages in the leveraging of novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties. It is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. 


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