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AcelRx Pharmaceuticals Inc (ACRX.OQ)

ACRX.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Acelrx Pharmaceuticals posts Q3 loss of $0.28 per share
Friday, 10 Nov 2017 

Nov 9 (Reuters) - Acelrx Pharmaceuticals Inc :Acelrx pharmaceuticals reports third quarter 2017 financial results.Q3 loss per share $0.28.Q3 revenue $1.5 million.Q3 revenue view $2.2 million -- Thomson Reuters I/B/E/S.Q3 earnings per share view $-0.27 -- Thomson Reuters I/B/E/S.Acelrx pharmaceuticals - $67.9 million of cash and cash equivalents at Sseptember 30, 2017​.  Full Article

AcelRx Pharma receives Complete Response Letter from the FDA for Dsuvia™ NDA
Thursday, 12 Oct 2017 

Oct 12 (Reuters) - Acelrx Pharmaceuticals Inc :AcelRx Pharmaceuticals receives Complete Response Letter from the FDA for Dsuvia™ NDA.AcelRx - ‍CRL states that FDA determined it cannot approve NDA in its present form and provides recommendations needed for resubmission​.AcelRx Pharmaceuticals Inc - ‍confirm plans to move towards resubmission of Dsuvia NDA​.AcelRx Pharmaceuticals Inc - ‍AcelRx ended Q3 with an estimated $67.9 million in cash and we will provide further financial updates on our Q3 earnings call​.AcelRx Pharmaceuticals-will request a meeting with FDA to discuss topics covered in CRL.AcelRx Pharmaceuticals Inc - ‍ received a complete response letter from FDA regarding its new drug application for Dsuvia, 30 MCG​.AcelRx - in CRL, collection of additional data requested on at least 50 patients to assess safety of dsuvia dosed at maximum amount set in proposed labelling​.AcelRx Pharmaceuticals Inc - ‍in CRL, FDA recommended certain changes to directions for use to address use-related errors, including dropped tablets​.  Full Article

Acelrx Pharmaceuticals submits drug application for acute pain treatment
Tuesday, 13 Dec 2016 

Acelrx Pharmaceuticals Inc : Acelrx Pharmaceuticals submits new drug application for ARX-04 for the treatment of moderate-to-severe acute pain .Using NDA for marketing authorization application for ARX-04 to european medicines agency with target submission date in H1 2017.  Full Article

Acelrx Pharma says amended loan and security deal with Hercules Tech II and Hercules Capital Inc
Tuesday, 4 Oct 2016 

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
Friday, 29 Jul 2016 

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 

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
Wednesday, 30 Mar 2016 

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 

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