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AcelRx Pharmaceuticals Inc (ACRX.O)

ACRX.O on Consolidated Issue listed on NASDAQ Global Market

2.00USD
20 Oct 2017
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$0.25 (+14.29%)
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Latest Key Developments (Source: Significant Developments)

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 Pharmaceuticals updates on notification from U.S. FDA
Wednesday, 7 Jun 2017 06:34am EDT 

June 7 (Reuters) - Acelrx Pharmaceuticals Inc ::U.S. FDA notified co that it no longer plans to hold an advisory committee meeting in connection with its review of NDA for Dsuvia.Decision does not alter PDUFA goal date for completion of review of NDA, which remains October 12, 2017 - SEC filing.  Full Article

Acelrx Pharmaceuticals files for mixed shelf of up to $150 mln
Monday, 5 Jun 2017 05:16pm EDT 

June 5 (Reuters) - Acelrx Pharmaceuticals Inc ::Acelrx Pharmaceuticals Inc files for mixed shelf of up to $150.0 million - sec filing.  Full Article

Acelrx Pharmaceuticals CFO Timothy Morris resigns
Monday, 5 Jun 2017 06:44am EDT 

June 5 (Reuters) - Acelrx Pharmaceuticals Inc :Acelrx Pharmaceuticals - on June 2, CFO Timothy E. Morris notified co of his resignation from all positions with co effective immediately - SEC filing.Acelrx Pharmaceuticals - ‍Vincent Angotti, co's chief executive officer, has been appointed to act as interim chief financial officer of co​ - SEC filing.  Full Article

AcelRx Pharmaceuticals reports Q1 total revenue $3.1 million
Monday, 8 May 2017 04:01pm EDT 

May 8 (Reuters) - AcelRx Pharmaceuticals Inc :AcelRx Pharmaceuticals reports first quarter 2017 financial results and provides corporate update.Q1 loss per share $0.34.Q1 earnings per share view $-0.27 -- Thomson Reuters I/B/E/S.AcelRx Pharmaceuticals - As of March 31, AcelRx had cash, cash equivalents and investments of $72.3 million, compared to $80.3 million at December 31, 2016.Q1 total revenue $3.1 million versus $3.0 million.  Full Article

AcelRx Pharma says DSUVIA resulted in 3-point reduction in pain intensity within 60 minutes of administration
Thursday, 6 Apr 2017 07:00am EDT 

AcelRx Pharmaceuticals Inc : AcelRx Pharmaceuticals presenting comprehensive DSUVIA clinical trial results at ASRA's annual regional anesthesiology and acute pain medicine meeting . AcelRx Pharma -DSUVIA may have benefit as non-invasive analgesic modality in certain settings requiring short-term treatment of acute moderate-to-severe pain . AcelRx Pharmaceuticals Inc- no statistical separation was observed between active and placebo-controlled groups for dsuvia .AcelRx Pharmaceuticals - in emergency department study, DSUVIA resulted in a 3-point reduction in pain intensity within 60 minutes of administration.  Full Article

AcelRx Pharma shares sink as FDA rejects opioid painkiller

Shares of AcelRx Pharmaceuticals Inc plunged more than 60 percent on Thursday after the U.S. Food and Drug Administration declined to approve its opioid painkiller Dsuvia.