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March 4, 2013
18:03 EDTACRXAcelRx reports primary endpoint achieved in Sufentanil NanoTab PCA phase 3 trial
AcelRx Pharmaceuticals announced top-line data results demonstrating that the first of two pivotal placebo-controlled Phase 3 studies for its investigational sublingual Sufentanil NanoTab PCA System met its primary endpoint. Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups. "These favorable results enable AcelRx to continue moving forward towards submission of a New Drug Application for the Sufentanil NanoTab PCA System in the third quarter of this year. In the weeks ahead, our team will work with the FDA to complete a pre-NDA meeting in support of this goal," said AcelRx CEO Richard King.
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July 27, 2014
13:25 EDTACRXFDA issues Complete Response Letter for AcelRx NDA for Zalviso
AcelRx Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, for the company's new drug application, NDA, for Zalviso, sufentanil sublingual tablet system. The company is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA.The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. We believe some of the requests have been addressed in amendments to the NDA that have been submitted prior to the receipt of the CRL but, as acknowledged by the FDA, have not been reviewed. There is no guarantee that the information previously provided to the FDA will be adequate to address the issues in the CRL. Additional bench testing will be required and human factors testing may be required to address certain items in the CRL. There were no requests to conduct additional human clinical studies. "We believe we can satisfy all of FDA's requests in the CRL and resubmit the NDA by the end of 2014, although we will have more clarity on the process and timing after our conversation with FDA," said Richard King, president and CEO of AcelRx. "We are confident in the Zalviso development program and will work closely with the FDA to address the Agency's concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso."
July 25, 2014
17:58 EDTACRXAcelRx trading halted, pending news
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15:43 EDTACRXAcelRx volatility elevated into July 27 PDUFA date for Zalviso
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09:25 EDTACRXOn The Fly: Pre-market Movers
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05:24 EDTACRXAcelRx confirms July 27 PDUFA date for Zalviso
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July 18, 2014
09:00 EDTACRXAcelRx attractive ahead of Zalviso PDUFA, says Roth Capital
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