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Stock Market & Financial Investment News

News Breaks
May 30, 2014
09:06 EDTBDSIBioDelivery Sciences June volatility elevated into PDUFA date for Bunavail
BioDelivery Sciences June call option implied volatility is at 109, July is at 101, September is at 99, December is at 90; its 26-week average of 72 according to Track Data suggesting large near term price movement into a PDUFA date for Bunavail on June 6.
News For BDSI From The Last 14 Days
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August 13, 2015
09:20 EDTBDSIOn The Fly: Pre-market Movers
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07:07 EDTBDSIBioDelivery Sciences' new Onsolis formulation approved by FDA
BioDelivery Sciences announced the approval by the FDA of a Supplemental New Drug Application for a new formulation of Onsolis CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. The new formulation was submitted to address previously announced appearance-related changes. Early this year, BDSI entered into an assignment and revenue sharing agreement with its partner for Onsolis, Meda Pharmaceuticals, to return the marketing authorization back to BDSI and the right to seek marketing authorizations for Onsolis in the U.S., Canada and Mexico. Meda retains the rights to Onsolis outside the U.S., where it is marketed in the E.U. as Breakyl. Onsolis is separately licensed by BDSI in Taiwan and South Korea.

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