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February 19, 2013
07:34 EDTACRXAcelRx says Phase 3 trials continue to progress
AcelRx Pharmaceuticals announced continuing progress on its two remaining Phase 3 trials of the Sufentanil NanoTab PCA System being studied in post-operative pain. The first of those studies in patients after major abdominal surgery completed the last patient earlier this quarter, and is expected to provide data later this quarter. The second study, in patients after major orthopedic surgery, continues to enroll patients, with the last patient expected to enroll around the end of the first quarter of 2013, and data expected in the second quarter.  A New Drug Application submission for the NanoTab System remains on track for the third quarter of 2013.  In addition, a Phase 2 clinical trial with ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, has completed dosing and results from this study are expected to be available in the second quarter of 2013, the company said.
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October 1, 2015
06:09 EDTACRXAcelRx to host analyst and investor day
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September 21, 2015
07:02 EDTACRXPDL BioPharma acquires a portion of AcelRx's expected sales for $65M
PDL BioPharma (PDLI) announced that it has acquired a portion of the royalties on expected sales of AcelRx Pharmaceuticals (ACRX) Zalviso in the European Union, Switzerland and Australia by its commercial partner, Grunenthal. Under the terms of the agreement, PDL has provided AcelRx with gross proceeds of $65M, and in exchange, PDL will receive 75% of the royalties AcelRx receives from Grunenthal as well as 80% of the first four commercial milestones subject to a capped amount. Zalviso is a combination drug and device product which, using a patient controlled dispenser, delivers a sub-lingual formulation of sufentanil, an opioid with a high therapeutic index. It is being evaluated for the treatment of moderate to severe post-operative pain in the hospital setting and could be used in lieu of intravenous patient-controlled analgesia. Zalviso has been submitted for product approval in the European Union and has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. Pending approval, Grunenthal expects to launch Zalviso beginning in the first half of 2016, and PDL expects to begin receiving royalties shortly thereafter.

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