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News Breaks
November 14, 2012
19:49 EDTACRXAcelRX met primary endpoint in Phase 3 trial
AcelRx Pharmaceuticals announced it had met the primary endpoint in the Phase 3 non-inferiority study of the sublingual Sufentanil NanoTab PCA System vs. IV PCA with morphine. The top-line data is expected to be released prior to market opening on November 15. AcelRx management will host an conference call at 8:00 a.m. EST to discuss the Phase 3 top-line results.
News For ACRX From The Last 14 Days
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July 24, 2015
08:34 EDTACRXAcelRx's Zalviso recommended for marketing authorization by Europe's CHMP
AcelRx Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, has adopted a positive opinion for Zalviso. The opinion, while not binding, recommends marketing authorization for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. Zalviso is an investigational drug-device combination product designed to deliver a sublingual formulation of sufentanil 15 mcg via a proprietary pre-programmed, non-invasive, patient-controlled device. The positive opinion by the CHMP will next be reviewed by the European Commission for central marketing authorization in the European Union. If approved, Grunenthal expects to launch Zalviso beginning in 1H16. In addition, AcelRx would be eligible to receive a $15M milestone payment from AcelRx's licensee in Europe, Grunenthal, upon approval. AcelRx had previously received CE Mark approval of the Zalviso device and ISO certification of its quality management system issued by the British Standards Institution.

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