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News Breaks
March 14, 2014
06:39 EDTBDSI, ENDPBioDelivery Sciences reports Bunavail PDUFA date of June 7
BioDelivery Sciences (BDSI) announced that in 2013, BDSI made important progress in significantly advancing and building its product portfolio in pain and addiction treatment and made meaningful strides in its continuing evolution from a development stage entity to a commercial enterprise. This included significant progress in the development of BDSI's two buprenorphine-containing products, BUNAVAIL for the maintenance treatment of opioid dependence and BEMA Buprenorphine, in partnership with Endo Pharmaceuticals, for the treatment of moderate to severe chronic pain. A New Drug Application, or NDA, for Bunavail was submitted to the FDA in mid-2013 and has a Prescription Drug User Fee Act, or PDUFA, date of June 7. In January, BDSI and Endo (ENDP) announced positive top-line results from the Phase 3 clinical trial of BEMA Buprenorphine in opioid naive patients. A second Phase 3 pivotal study for BEMA Buprenorphine, which is ongoing and being conducted in opioid experienced patients, is expected to report top-line results in mid-2014. In addition to the progress on its two buprenorphine containing products, BDSI expanded its product portfolio in 2013 by in-licensing Clonidine Topical Gel, a proposed treatment for painful diabetic neuropathy. Following a positive end of Phase 2 meeting with FDA in November, BDSI will begin this quarter enrolling patients in the first of two Phase 3 studies
News For BDSI;ENDP From The Last 14 Days
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August 19, 2014
07:34 EDTBDSIBioDelivery Sciences management to meet with William Blair
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August 14, 2014
07:46 EDTENDPEndo valuation attractive, says Goldman
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August 12, 2014
07:11 EDTBDSIBioDelivery Sciences and Endo Pharmaceuticals report on BEMA Buprenorphine NDA
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August 8, 2014
09:00 EDTBDSI, ENDPBioDelivery Sciences still a takeover target, says Janney Capital
Janney Capital continues to believe that BioDelivery Sciences (BDSI) could be a takeover target, noting that it thinks partner Endo International (ENDP) could be a potential buyer if BioDelivery has more positive top-line results and if the market weakens. The firm, which added that it likes BioDelivery Sciences as a stand-alone company as well, maintains its Buy rating and $15 fair value estimate on the stock.
August 7, 2014
17:29 EDTBDSIBioDelivery Sciences sees U.S. launch of Bunavail in late Q3
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17:27 EDTBDSIBioDelivery Sciences reports Q2 EPS (14c), consensus (13c)
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August 6, 2014
07:13 EDTBDSIBioDelivery Sciences updates ongoing Phase 3 trial for Clonidine Topical Gel
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