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Stock Market & Financial Investment News

News Breaks
June 2, 2014
16:18 EDTACRXAcelRx Chief Commercial Officer David Chung resigns
AcelRx Pharmaceuticals announced that David Chung has resigned as Chief Commercial Officer in order to assume the role of CEO of a medical device company. Richard King, the company's President and CEO, will assume the duties and responsibilities of the Chief Commercial Officer, and will lead the continued build-out of the commercial organization and launch preparation for Zalviso until a suitable replacement is found. The Company has begun a search for Mr. Chung's replacement.
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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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