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News Breaks
July 7, 2014
05:17 EDTACRXAcelRx announces submission of MAA for Zalviso
AcelRx and Grunenthal Group announced that Grunenthal has submitted a Marketing Authorization Application, or MAA, to the European Medicines Authority for Zalviso for the management of moderate to severe acute pain in adult patients in a medically supervised environment. Zalviso is a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device. AcelRx and Grunenthal entered into license and supply agreements for Zalviso in the EU, Australia and certain other countries in December 2013. Under the terms of the license agreement, AcelRx will receive a cash payment of $5M for the MAA submission. AcelRx is eligible to receive an additional $15M milestone payment upon the approval of the MAA. After approval by EMA, AcelRx is eligible to receive approximately $200M in additional milestone payments, based upon successful regulatory and product development efforts and net sales target achievements. Grunenthal will also make tiered royalty, supply and trademark fee payments in the mid-teens up to the twenty percent range, on net sales of Zalviso in the Grunenthal territory.
News For ACRX From The Last 14 Days
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March 20, 2015
15:04 EDTACRXAcelRx to reduce workforce by approximately 36%
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15:02 EDTACRXAcelRx names Howard Rosen as interim CEO
AcelRx Pharmaceuticals (ACRX) announced the appointment of Howard Rosen as interim CEO of AcelRx, effective April 1. Rosen is a technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences (GILD) and ALZA Corporation. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra and several private biopharmaceutical companies.
March 16, 2015
09:22 EDTACRXOn The Fly: Pre-market Movers
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07:01 EDTACRXAcelRx initiates Phase 3 trial for ARX-04
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