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AcelRx Pharmaceuticals Inc (ACRX.OQ)

ACRX.OQ on NASDAQ Stock Exchange Global Market

2.33USD
25 Apr 2018
Change (% chg)

$-0.03 (-1.06%)
Prev Close
$2.35
Open
$2.40
Day's High
$2.40
Day's Low
$2.33
Volume
20,115
Avg. Vol
51,341
52-wk High
$5.75
52-wk Low
$1.58

Latest Key Developments (Source: Significant Developments)

Acelrx Pharmaceuticals posts Q3 loss of $0.28 per share
Thursday, 9 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
Monday, 3 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
Thursday, 28 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

BRIEF-Acelrx Announces Completion Of The Human Factors Study For Dsuvia And Confirms Plans To Resubmit NDA

* ACELRX ANNOUNCES COMPLETION OF THE HUMAN FACTORS STUDY FOR DSUVIA AND CONFIRMS PLANS TO RESUBMIT NDA IN Q2 2018 Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)