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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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November 13, 2014
07:08 EDTACRXAcelRx to present positive efficacy results in Phase 3 trial of Zalviso
AcelRx Pharmaceuticals will present safety and efficacy data from a Phase 3 pivotal trial evaluating the Zalviso sufentanil sublingual tablet system for the treatment of moderate-to-severe acute pain following joint replacement surgery at the American Society of Regional Anesthesia and Pain Medicine 13th Annual Pain Medicine Meeting on November 13th to November 16th in San Francisco. Data from the sublingual sufentanil tablet system development program highlights efficacy across various demographic populations
November 11, 2014
10:20 EDTACRXHigh option volume stocks
High option volume stocks: RLGY TWC LITB SPM ACRX JWN OCR CALL CST ERIC
November 10, 2014
16:16 EDTACRXAcelRx sees FY14 R&D expenses $25M-$27M
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16:15 EDTACRXAcelRx reports Q3 EPS (13c), consensus (22c)
Reports Q3 revenue $4.83M, consensus $4.43M.
07:12 EDTACRXAcelRx receives ISO certification of its quality management system
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