BioDelivery Sciences (BDSI) shares are plummeting today for almost 60% after the company announced the primary endpoint in its Phase 3 clinical study of a pain drug was not reached:
BioDelivery Sciences BEMA Buprenorphine study for the treatment of moderate to severe pain in a mixed opioid nave and opioid experienced population, the overall pain intensity difference of the drug versus a placebo was not achieved. However, the company said, it believes the totality of the study results favor the drug, including a near statistically significant difference in the opioid experienced patients.
Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, commented:
“We continue to believe that BEMA Buprenorphine has the opportunity to be the first transmucosal product for the treatment of chronic pain to reach the marketplace. Our previously announced market projections for the product of $500 million in annual peak sales should not change based on the delay this outcome creates, and we will continue our ongoing partnering discussions in earnest, including the sharing of these results, which we believe should be viewed positively. We anticipate our partner discussions will also aid us in refining the design for our next study. In summary, we firmly believe that the future of BEMA Buprenorphine for chronic pain, and for our company in general remains bright.”
On the bright side BDSI’s options volume got an increase of 728%. Over 3,000 October $2.50 calls were sold for $0.05 and $0.10 against existing open interest. Ready for the bounce? We do.
BioDelivery Sciences International Inc.
801 Corporate Center Drive
Raleigh, NC 27607
United States – Map
BioDelivery Sciences (“BDSI“®) is a specialty pharmaceutical company with a focus in the areas of pain management and oncology supportive care. BDSI is utilizing its novel and proprietary drug delivery technologies to develop and commercialize, either on their own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.