United States

AcelRx Pharmaceuticals Inc (ACRX.O)

ACRX.O on Consolidated Issue listed on NASDAQ Global Market

22 Aug 2017
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Latest Key Developments (Source: Significant Developments)

Acelrx says U.S. app to market painkiller Dsuvia accepted by FDA
Monday, 27 Feb 2017 07:00am EST 

Acelrx Pharmaceuticals Inc : Acelrx pharmaceuticals' new drug application for dsuvia accepted for filing with pdufa date of october 12, 2017 .Acelrx pharma- fda communicated it plans to hold advisory committee meeting to review dsuvia application, date of meeting is yet to be determined.  Full Article

Acelrx Pharma says amended loan and security deal with Hercules Tech II and Hercules Capital Inc
Monday, 3 Oct 2016 04:53pm EDT 

Acelrx Pharmaceuticals Inc : Among other things, amendment extends interest-only period from October 1, 2016 to April 1, 2017 - SEC filing .On September 30, co amended loan and security deal with Hercules Technology II, L.P. and Hercules Capital, Inc..  Full Article

Acelrx Pharmaceuticals Q2 loss per share $0.24
Thursday, 28 Jul 2016 04:10pm EDT 

Acelrx Pharmaceuticals Inc : Acelrx Pharmaceuticals provides corporate update and reports second quarter and six months 2016 financial results . Q2 loss per share $0.24 .Q2 earnings per share view $-0.22 -- Thomson Reuters I/B/E/S.  Full Article

Acelrx Pharmaceuticals says start date for IAP312 study revised
Friday, 8 Jul 2016 06:15am EDT 

Acelrx Pharmaceuticals Inc: Acelrx Pharmaceuticals Inc says has finalized certain modifications to the Zalviso device and pending receipt of the devices from the manufacturer . Says on July 6, 2016, the start date for the IAP312 study was revised to September 2016 - SEC filing .Start date for study may be delayed if devices received from manufacturer do not pass final quality checks, certain release specifications.  Full Article

AcelRx Pharmaceuticals Inc names Howard B. Rosen as Chief Executive Officer
Tuesday, 29 Mar 2016 04:00pm EDT 

AcelRx Pharmaceuticals Inc:Says appointment of Howard B. Rosen as the Chief Executive Officer of AcelRx, effective April 1, 2016.Says Rosen has served as the interim CEO for AcelRx since April 1, 2015.  Full Article

AcelRx Pharmaceuticals Inc says Zalviso additional clinical study to start in Q1
Thursday, 11 Feb 2016 07:01am EST 

AcelRx Pharmaceuticals Inc:Presents phase 3 results from arx-04 clinical program at jab burn and wound care symposium.In response to NDA Co submitted to FDA seeking approval for zalviso, Acelrx received complete response letter on July 25, 2014.FDA has requested an additional clinical study, which Co is planning to initiate in Q1 2016, to support resubmission of NDA.  Full Article

AcelRx Pharmaceuticals Inc conducts Pre-NDA Meeting with U.S. Food and Drug Administration for ARX-04
Monday, 14 Dec 2015 07:00am EST 

AcelRx Pharmaceuticals Inc:Anticipates the Submission of the ARX-04 New Drug Application in the Second Half of 2016.FDA Agrees to Include a Significant Number of Patients from the Zalviso Studies into the ARX*04 Safety Database.  Full Article

AcelRx Pharmaceuticals reports that the European Commission has granted marketing authorization for zalviso
Tuesday, 22 Sep 2015 08:41am EDT 

AcelRx Pharmaceuticals Inc:Says that the European Commission (EC) has approved Zalviso (15 micrograms sufentanil sublingual tablets) for the management of acute moderate-to-severe post-operative pain in adult patients.Expects the product to be available to Western European patients in the first half of 2016.  Full Article

AcelRx Pharmaceuticals Inc Receives $65 Million from the Partial Sale of Zalviso(tm) European Royalties and Commercial Milestones to PDL BioPharma
Monday, 21 Sep 2015 07:00am EDT 

AcelRx Pharmaceuticals Inc:Announced the monetization of the expected royalty stream from the sales of Zalviso(sufentanil sublingual tablet system) in the European Union by its commercial partner Grunenthal GmbH.Says Gross proceeds from the sale are $65 million from PDL BioPharma.Specifically, PDL will receive 75% of the European royalties under the Grunenthal license as well as 80% of the first four commercial milestones, subject to a capped amount.AcelRx will receive 25% of the royalties, 20% of the first four commercial milestones, 100% of the remaining commercial milestones and all development milestones, including a potential $15 million payment for the approval of the Zalviso MAA.Says The proceeds from the transaction will provide AcelRx with additional operating capital, which will be used for general corporate purposes, including regulatory activities associated with ARX-04 and Zalviso.  Full Article

BRIEF-Acelrx Pharmaceuticals Q2 loss per share $0.29

* Acelrx Pharmaceuticals reports second quarter 2017 financial results and provides corporate update