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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 1, 2014
07:46 EDTENDPEndo price target raised to $84 from $75 at Stifel
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July 29, 2014
10:05 EDTENDPEndo shares remain overvalued, says Cantor
Cantor Fitzgerald raised its priced target for Endo shares to $52 from $37 ahead of the company's Q2 results, but says the stock remains overvalued. The firm keeps a Sell rating on the name.
July 23, 2014
10:02 EDTENDPOn The Fly: Analyst Initiation Summary
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08:10 EDTENDPDeutsche Bank hosts an analyst Specialty Pharma/Industry conference call
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July 22, 2014
16:09 EDTENDPEndo initiated with a Buy at Deutsche Bank
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