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AcelRx Pharmaceuticals Inc (ACRX.OQ)

ACRX.OQ on NASDAQ Stock Exchange Global Market

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Change (% chg)

$0.58 (+14.57%)
Prev Close
$3.98
Open
$4.80
Day's High
$5.03
Day's Low
$4.51
Volume
2,071,242
Avg. Vol
229,970
52-wk High
$5.03
52-wk Low
$1.58

Latest Key Developments (Source: Significant Developments)

Industry Ventures Secondary VIII Reports 7.30 Pct Passive Stake In Acelrx Pharmaceuticals
Thursday, 31 May 2018 11:19am EDT 

May 31 (Reuters) - AcelRx Pharmaceuticals Inc ::INDUSTRY VENTURES SECONDARY VIII, L.P. REPORTS 7.30 PERCENT PASSIVE STAKE IN ACELRX PHARMACEUTICALS INC AS OF MAY 21, 2018 - SEC FILING.  Full Article

AcelRx Announces FDA Acceptance Of NDA For Dsuvia
Thursday, 24 May 2018 07:00am EDT 

May 24 (Reuters) - AcelRx Pharmaceuticals Inc ::ACELRX PHARMACEUTICALS INC - DSUVIA PDUFA DATE SET FOR NOVEMBER 3, 2018.ACELRX ANNOUNCES FDA ACCEPTANCE OF NDA FOR DSUVIA.ACELRX PHARMACEUTICALS INC - FDA CONSIDERS DSUVIA NDA RESUBMISSION A COMPLETE CLASS 2 RESPONSE TO THEIR OCTOBER 2017 ACTION LETTER.  Full Article

AcelRx Pharmaceuticals Reports Q1 Loss Per Share $0.23
Wednesday, 9 May 2018 04:05pm EDT 

May 9 (Reuters) - AcelRx Pharmaceuticals Inc ::ACELRX PHARMACEUTICALS REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS.Q1 LOSS PER SHARE $0.23.Q1 EARNINGS PER SHARE VIEW $-0.24 -- THOMSON REUTERS I/B/E/S.EXPECTED ACCEPTANCE OF DSUVIA NDA BY FDA IN Q2 2018.POTENTIAL EUROPEAN COMMISSION APPROVAL OF DZUVEO IN Q3 2018.MARCH 31, 2018 CASH AND SHORT-TERM INVESTMENTS BALANCE OF $51.2 MILLION.  Full Article

AcelRx Pharma Q4 Loss Per Share $0.20
Thursday, 8 Mar 2018 04:06pm EST 

March 8 (Reuters) - AcelRx Pharmaceuticals Inc ::ACELRX PHARMACEUTICALS REPORTS FOURTH QUARTER 2017 FINANCIAL RESULTS.Q4 LOSS PER SHARE $0.20.Q4 EARNINGS PER SHARE VIEW $-0.20 -- THOMSON REUTERS I/B/E/S.ANTICIPATED RESUBMISSION OF NDA FOR DSUVIA IN Q2 2018.ANTICIPATED PDUFA DATE FOR DSUVIA IN Q4 2018.EXPECTED FDA ADVISORY COMMITTEE MEETING FOR DSUVIA IN Q3 2018.ANTICIPATES RESUBMISSION OF NDA FOR ZALVISO IN H2 2018.QTRLY TOTAL REVENUE 740,000.  Full Article

Acelrx Pharmaceuticals posts Q3 loss of $0.28 per share
Thursday, 9 Nov 2017 04:01pm EST 

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 06:45am EDT 

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 says co entered into 2nd amendment with Patheon Pharma
Wednesday, 23 Aug 2017 06:32am EDT 

Aug 23 (Reuters) - Acelrx Pharmaceuticals Inc :Acelrx Pharmaceuticals - on August 22, co entered second amendment to manufacturing services deal effective as of august 4, 2017, with Patheon Pharma.Acelrx pharmaceuticals - amendment related to manufacture of Sufentanil Sublingual tablets for use with co's product candidate, DSUVIA - SEC Filing.  Full Article

Acelrx Pharmaceuticals Q2 loss per share $0.29
Tuesday, 1 Aug 2017 07:05am EDT 

Aug 1 (Reuters) - Acelrx Pharmaceuticals Inc :Acelrx Pharmaceuticals reports second quarter 2017 financial results and provides corporate update.Q2 loss per share $0.29.Q2 earnings per share view $-0.28 -- Thomson Reuters I/B/E/S.Qtrly total revenue $2.7 million versus $4.5 million.  Full Article

AcelRx Pharmaceuticals reports successful outcome of Zalviso phase 3 IAP312 study on device functionality
Tuesday, 1 Aug 2017 07:00am EDT 

Aug 1 (Reuters) - Acelrx Pharmaceuticals Inc :Acelrx Pharmaceuticals reports successful outcome of zalviso phase 3 IAP312 study on device functionality.Acelrx Pharmaceuticals- in study, 2.2% of patients experienced zalviso device error, which was statistically less than 5% limit specified in objectives​.Acelrx Pharmaceuticals Inc- ‍none of the device errors resulted in an over-dosing event in study​.Acelrx Pharmaceuticals- ‍Zalviso shown to be well tolerated in study, with nausea, hypotension, vomiting representing most commonly reported adverse events​.Acelrx Pharmaceuticals Inc- ‍a total of 5 patients experienced serious adverse events, but all were considered unrelated to study drug by investigators​.Acelrx Pharmaceuticals - intend to submit results, together with earlier phase 3 studies, as part of resubmission of nda to fda by end of 2017​.  Full Article

Acelrx Pharmaceuticals appoints Raffi Asadorian CFO
Wednesday, 19 Jul 2017 07:00am EDT 

July 19 (Reuters) - Acelrx Pharmaceuticals Inc -:Acelrx Pharmaceuticals appoints Raffi Asadorian as chief financial officer.Acelrx Pharmaceuticals Inc - ‍appointment of Raffi Asadorian as chief financial officer, effective August 16, 2017​.Acelrx Pharmaceuticals Inc - ‍asadorian most recently served as chief financial officer at Amyris​.  Full Article

AcelRx shares surge after FDA staff says opioid safe

AcelRx Pharmaceuticals Inc's shares surged 30 percent on Wednesday after U.S. Food and Administration staff said the company's opioid treatment was safe and effective, bringing it one step closer to a marketing approval.