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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.
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August 19, 2014
07:06 EDTACRXGuggenheim to hold a conference
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August 18, 2014
10:57 EDTACRXOptions with decreasing implied volatility
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August 11, 2014
16:05 EDTACRXAcelRx says disappointed on Zalviso CRL, to meet with FDA in September
"We were disappointed with the receipt of a Complete Response Letter for Zalviso and we look forward to meeting with the FDA to clarify the items included in the CRL and to discuss our planned response," stated Richard King, president and CEO of AcelRx. "We have spoken to the FDA and plan to meet with them by the end of September 2014. We anticipate we can refile the Zalviso NDA before the end of 2014, pending the outcome of the meeting with the FDA. We remain 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." The company reiterates and issues financial guidance for the year for total operating expenses to be in the range of $48M-$52M. Estimates cash, cash equivalents and investment balances at December 31 of at least $65M.
16:03 EDTACRXAcelRx reports Q2 EPS (30c), consensus (26c)
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