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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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October 27, 2014
07:23 EDTACRXAmerican College of Surgeons holds a conference
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October 24, 2014
07:56 EDTACRXAcelRx management to meet with BofA/Merrill
Meeting to be held in New York on October 29 hosted by BofA/Merrill.
October 22, 2014
07:19 EDTACRXAcelRx's Zalviso for abdominal pain shows positive Phase 3 results
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October 16, 2014
07:02 EDTACRXAcelRx updates patent portfolio for Zalviso and platform technologies
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