Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of BioDelivery Sciences International (BDSI), a biopharmaceutical company focused on developing therapies designed to treat pain management and oncology supportive care, skyrocketed by as much as 49% after it, and partner Endo Health Solutions (ENDP 16.67%), reported their top-line results from a phase 3 trial of BEMA buprenorphine in opioid-naïve patients with moderate-to-severe chronic pain.
So what: According to the press release, the phase 3 trial met its primary endpoint of a reduction in the daily average pain numerical rating scale scores from baseline in a study involving chronic back pain. There is also an ongoing second phase 3 trial that could have results as early as the second-half of 2014. The positive results also triggered a $10 million milestone payment to BioDelivery Sciences from Endo according to BioDelivery CEO Mark Sirgo.
Now what: Although this is just top-line data, and we don't have the exact figures yet as they relate to NRS-pain score reduction, the simple fact that we're looking at a broad patient trial (462 patients) that met its endpoint is great news for the smaller BioDelivery Sciences. Milestone payments go a long way to fueling future research for a company that will likely burn through about $30 million in fiscal 2014 in total operating expenses, and only had $38.3 million in cash in the bank as of last quarter. However, much of that optimism has been baked into BioDelivery's share price already, leaving little room for more upside barring a flawless second phase 3 trial, FDA approval, and drug launch.
