Key Developments: AcelRx Pharmaceuticals Inc (ACRX.O)

ACRX.O on Consolidated Issue listed on NASDAQ Global Market

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18 Sep 2014
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Latest Key Developments (Source: Significant Developments)

AcelRx Pharmaceuticals Inc receives complete response letter from FDA for new drug application for Zalviso
Friday, 25 Jul 2014 09:59pm EDT 

AcelRx Pharmaceuticals Inc and Grunenthal Group:Says that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company's new drug application (NDA) for Zalviso (sufentanil sublingual tablet system).Says the company is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA.  Full Article

AcelRx and Grunenthal announce submission of european marketing authorization application for ZALVISO
Monday, 7 Jul 2014 03:00am EDT 

AcelRx Pharmaceuticals Inc and Grunenthal Group:Says Grunenthal has submitted a Marketing Authorization Application (MAA) to the European Medicines Authority for ZALVISO for the management of moderate to severe acute pain in adult patients in a medically supervised environment.ZALVISO is a drug-device combination product utilizing the opioid agonist sufentanil formulated in a sublingual tablet formulation and delivered through a pre-programmed, non-invasive delivery device.AcelRx and Grunenthal entered into license and supply agreements for ZALVISOTMin the EU, Australia and certain other countries in Dec. 2013.AcelRx to receive a cash payment of $5 million for the MAA submission.Grunenthal will also make tiered royalty, supply and trademark fee payments in the mid-teens up to the twenty percent range, on net sales of ZALVISO in Grunenthal territory.  Full Article

AcelRx Pharmaceuticals Inc appoints Timothy E. Morris as Chief Financial Officer
Tuesday, 25 Mar 2014 07:30am EDT 

AcelRx Pharmaceuticals Inc:Appointment of Timothy E. Morris as chief financial officer.Jim Welch, who had served as CFO since Oct. 2010, departed company to pursue other business opportunities.  Full Article

AcelRx Pharmaceuticals Inc secures $40 mln credit facility with Hercules Technology Growth Capital
Thursday, 19 Dec 2013 07:30am EST 

AcelRx Pharmaceuticals Inc:Says it has entered into a new amended and restated credit facility with Hercules Technology Growth Capital, Inc.Says the new Hercules credit facility provides for up to $40 mln of new loans.Says it drew the first tranche of $15 mln at the closing of the new credit facility.Says it applied about $8.5 mln of the proceeds to repay its outstanding obligations under the prior credit facility with Hercules.Says the second tranche of up to $10 mln can be drawn, at its option, at any time prior to June 30, 2014.Says the third tranche of up to $15 mln is conditioned upon the approval of Zalviso by the U.S. FDA, and if approved, can be drawn at its option, at any time between Dec. 15, 2014 and Mar.15, 2015.Says it plans to use the proceeds of the remaining tranches to provide additional funding for the commercialization of Zalviso.Says and also as a potential source of funding for clinical trials for other development programs in its pipeline, and for general corporate purposes.  Full Article

AcelRx Pharmaceuticals Inc presents ARX-04 dose-finding phase two study data at Anesthesia Medical Conference
Friday, 13 Dec 2013 07:30am EST 

AcelRx Pharmaceuticals Inc:Says it has presented additional detail from the Phase two dose-finding study of ARX-04, an investigational single-dose sublingual sufentanil NanoTab for moderate-to-severe acute pain, for which topline results were reported in April 2013.Says patients treated with the 30 mcg dose of sufentanil showed a rapid onset of action with a statistically significant beneficial difference in pain relief (p <0.001) and pain intensity (p <0.01) seen at 30 minutes after dosing compared to placebo.Says Dosing averaged every 2.4 hours over the duration of the 12-hour study.Says in addition, patient global assessment of the 30 mcg dose at 12 hours was superior to placebo (p=0.002) with 43.6% vs. 5.0% of the patients responding good or excellent for overall pain control.Says the 20 mcg dose was not significant for either endpoint.Says this study was funded by a grant from the U.S. Army Medical Research and Materiel Command.Says these results are being presented at the 67th Annual PostGraduate Assembly in Anesthesia being held in New York City.  Full Article

AcelRx Pharmaceuticals Inc Submits New Drug Application To FDA For Zalviso
Monday, 30 Sep 2013 07:30am EDT 

AcelRx Pharmaceuticals, Inc announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zalviso (sufentanil sublingual microtablet system). Zalviso is a patient-activated, non-invasive analgesic system, which delivers 15 mcg sufentanil per dose as needed for pain control, subject to a 20 minute lockout period between doses. The proposed indication for Zalviso is the management of moderate-to-severe acute pain in adult patients in the hospital setting. The NDA submission is based primarily on data from a Phase 3 registration program that included two double-blind randomized placebo-controlled clinical trials, one conducted in patients following abdominal surgery, the other in patients following joint replacement surgery.  Full Article

AcelRx Pharmaceuticals Inc Announces Pricing of Public Offering of Common Stock
Thursday, 18 Jul 2013 09:24am EDT 

AcelRx Pharmaceuticals Inc announced the pricing of its previously announced underwritten public offering of 3.8 million shares of its common stock, offered at a price of $11.65 per share to the public. The gross proceeds to AcelRx from this offering are expected to be approximately $44.27 million, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by AcelRx. All of the shares in the offering are to be sold by AcelRx. The offering is expected to close on or about July 23, 2013, subject to the satisfaction of customary closing conditions. AcelRx has granted the underwriters a 30-day option to purchase up to an aggregate of 570,000 additional shares of common stock offered in the public offering. Jefferies LLC and Piper Jaffray & Co. acted as joint book-running managers for the offering, and Guggenheim Securities acted as co-manager for the offering.  Full Article

AcelRx Pharmaceuticals Inc Announces Proposed Public Offering Of Common Stock
Wednesday, 17 Jul 2013 04:01pm EDT 

AcelRx Pharmaceuticals Inc announced that it intends to offer and sell shares of its common stock in an underwritten public offering. The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares to be sold in the proposed offering are to be sold by AcelRx. Jefferies LLC and Piper Jaffray & Co. are acting as joint book-running managers for the offering, and Guggenheim Securities is acting as co-manager for the offering.  Full Article

AcelRx Pharmaceuticals Inc Announces Top-Line Data Demonstrate Primary Endpoint Achieved In Final Pivotal Phase 3 Study Of Sufentanil Nanotab PCA System For Management Of Post-Operative Pain
Tuesday, 21 May 2013 07:30am EDT 

AcelRx Pharmaceuticals Inc announced top-line data demonstrating that in a placebo-controlled Phase 3 study of its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System (NanoTab System), the primary efficacy endpoint was achieved. The study evaluated control of pain intensity compared to baseline during the 48-hour study period immediately following major orthopedic surgery, specifically knee or hip replacement, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (i.e. SPID-48). Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (+76.1 vs -11.5, p <0.001). Secondary endpoint data showed that SPID at 24 hours and 72 hours was also significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p <0.001 in each case). Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups for the majority of adverse events. Utilizing a randomized, double-blind, placebo-controlled design, this pivotal Phase 3 study enrolled 426 adult patients at 34 U.S. sites for treatment of moderate=to-severe acute pain immediately following major orthopedic surgery. Seven patients did not receive study drug, resulting in 419 patients being included in the intent-to-treat (ITT) population.  Full Article

AcelRx Pharmaceuticals Inc Announces That Top-line Data Show Primary Endpoint Achieved in Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Post-Operative Pain
Monday, 4 Mar 2013 06:00pm EST 

AcelRx Pharmaceuticals Inc announced top-line data results demonstrating that the first of two pivotal placebo-controlled Phase 3 studies for its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint. Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups. The primary endpoint evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery. Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (p=0.001). Secondary endpoint data also showed that 24 hours and 72 hours after first dose, SPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p=0.004 respectively). Utilizing a randomized, double-blind, placebo-controlled design, this pivotal Phase 3 study enrolled 178 adult patients at 13 U.S. sites for the treatment of acute post-operative pain immediately following major abdominal surgery. Patients were treated for post-operative pain for a minimum of 48 hours, and up to 72 hours.  Full Article

AcelRx stock plunges after FDA rejects pain drug device

- Shares of AcelRx Pharmaceuticals Inc plunged almost 40 percent after the U.S. Food and Drug Administration rejected its pain treatment late on Friday.

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