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AcelRx Pharmaceuticals, Inc. Message Board

  • minnesotafarmcountry minnesotafarmcountry Aug 12, 2013 4:15 PM Flag

    Earnings

    With the successful completion of our Zalviso™ clinical program that includes data from all three Phase 3 studies, each of which met its primary endpoint, we are preparing to submit our New Drug Application (NDA), by the end of the third quarter," stated Richard King, president and CEO of AcelRx. "We were pleased with the financing completed last month in which we raised almost $48 million in net proceeds. This additional cash provides the resources to fund operations at least through the end of 2014 including commercial preparation activities for, and the potential launch of, Zalviso in the United States

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    • I would expect the NDA timing statement will help drive this PPS up over the next few days. We are getting closer and closer to an approval. Do you know how long it takes for the NDA review?

      • 2 Replies to titusmabon
      • Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is "sufficiently complete to permit a substantive review". If the NDA is found to be insufficiently complete (and reasons for this can vary from a simple administrative mistake in the application to a requirement to reconduct much of the testing), then the FDA rejects the application with the issue of a Refuse to File letter which is sent to the applicant explaining where the application has failed to meet requirements.[5]

        Assuming that everything is found to be acceptable, the FDA will decide if the NDA will get a standard or accelerated review and communicate the acceptance of the application and their review choice in another communication known as the 74-day letter.[6] A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months

      • typically pdufa is around 6 months after nda

    • Here we go!!!

      Sentiment: Strong Buy

      • 2 Replies to neurodragon007
      • Where? Appears to be non event , down a penny ah

      • Second Quarter Financial Results

        Net loss for the second quarter of 2013 was $17.4 million, or $0.47 per share, compared with a net loss of $7.2 million, or $0.35 per share for the second quarter of 2012. Adjusted net loss for the second quarter of 2013 was $8.1 million, or $0.22 per share and excludes the $9.3 million non-cash expense resulting from the liability accounting related to warrants issued in connection with the PIPE financing completed in June 2012. There was no such expense recorded in the second quarter of 2012.

        During the second quarters of 2013 and 2012, AcelRx recognized revenue of $407,000 and $224,000, respectively, as reimbursement for work completed under a research grant from the U.S. Army Medical Research and Materiel Command (USAMRMC), for development of ARX-04, a sufentanil NanoTab product candidate for the treatment of moderate-to-severe acute pain in a range of ambulatory environments.

        Research and development (R&D) expenses for the quarter ended June 30, 2013 totaled $6.1 million, compared with $5.4 million for the quarter ended June 30, 2012. Phase 3 clinical costs for Zalviso, AcelRx's lead product candidate designed to improve the management of moderate-to-severe acute pain in patients in the hospital setting, were very similar in the quarters ending June 30, 2013 and 2012. The increase over the quarter ended June 30, 2012 was primarily due to personnel related costs, including stock compensation expenses. R&D expenses in the preceding quarter ended March 31, 2013 were $9.3 million, and the decrease to $6.1 million in R&D expenses in the quarter ended June 30, 2013 reflects lower Zalviso Phase 3 costs as we completed the Phase 3 clinical program.

        General and administrative expenses were $2.1 million for the second quarter of 2013, compared with $1.8 million for the second quarter of 2012, due primarily to an increase in market research activities.

        Other income and expense includes the $9.3 million non-cash charge in the second quarter of 2013 resulting from the liability accounting related to the warrants issued in connection with the PIPE financing completed in June 2012. The primary determinant of this charge was an increase in share price during the second quarter of 2013 and its resulting impact on the Black-Scholes valuation of these warrants.

        For the six months ended June 30, 2013, AcelRx reported a net loss of $30.2 million, or $0.81 per share, compared with a net loss of $14.3 million, or $0.71 per share for the same period in 2012. Adjusted net loss for the six months ended June 30, 2013 was $19.2 million, or $0.52 per share. Adjusted net loss excludes the $11.0 million non-cash expense resulting from the liability accounting related to the warrants issued in connection with the PIPE financing completed in June 2012.

        R&D expenses for the six months ended June 30, 2013 totaled $15.4 million, compared with $10.2 million for the six months ended June 30, 2012. The increase over the six months ended June 30, 2012 was primarily due to expenses associated with Phase 3 clinical studies of Zalviso. General and administrative expenses were $4.3 million for the six months of 2013, compared with $3.9 million for the six months ended June 30, 2012 due primarily to an increase in stock based compensation.

        As of June 30, 2013, AcelRx had cash, cash equivalents and investments of $36.8 million, compared to $59.8 million at December 31, 2012 and $48.2 million at March 31, 2013. In July 2013, we raised approximately $47.9 million in net proceeds through the issuance of 4.37 million shares of common stock in an underwritten public offering.

 
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