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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 9, 2015
20:11 EDTACRXAcelRx management to meet with Roth Capital
Meeting to be held in San Francisco on October 15 hosted by Roth Capital.
October 8, 2015
07:02 EDTACRXAcelRx provides update on Zalviso
AcelRx provided a regulatory update on Zalviso intended for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has received formal minutes of the telephonic meeting held in early September 2015, with the Division of Anesthesia, Analgesia, and Addiction Products of the FDA. As reflected in the minutes, the Division restated at the meeting a request for clinical data to complement other data AcelRx has developed to assess the overall performance of the Zalviso device. The company is planning to submit a protocol to the Division for a clinical study in post-operative patients designed to evaluate the effectiveness of changes made to enhance product performance. AcelRx expects to be ready to initiate the study in the first quarter of 2016, and likely will await comments on the protocol from the Division. The company will be prepared to work with the FDA to facilitate the timely study initiation.
October 6, 2015
07:01 EDTACRXAcelRx announces initiation of clinical study of ARX-04 in ER patients
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October 5, 2015
09:08 EDTACRXAcelRx price target raised to $10.50 from $8.50 at Roth Capital
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October 1, 2015
06:09 EDTACRXAcelRx to host analyst and investor day
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