Key Developments: AcelRx Pharmaceuticals Inc (ACRX.O)

ACRX.O on Consolidated Issue listed on NASDAQ Global Market

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23 Apr 2014
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Latest Key Developments (Source: Significant Developments)

AcelRx Pharmaceuticals Inc Presents Top-Line Data From Phase 3 Study Of Sufentanil NanoTab PCA System vs. IV PCA Morphine
Friday, 14 Dec 2012 07:30am EST 

AcelRx Pharmaceuticals Inc announced top-line data from previously announced open-label, active-comparator study of lead product candidate, the Sufentanil NanoTab PCA System. Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p <0.001) to intravenous (IV) patient-controlled analgesia (PCA) with morphine for primary endpoint of Patient Global Assessment (PGA) of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of good or excellent (78.5% vs. 66.1% respectively). The assessment of non-inferiority is based on a lower limit of -15% for the 95% confidence interval (CI) around the difference between these percentages. Because the 95% CI was +3.2% to +21.6% for the 48-hour PGA, a statistical analysis for superiority could be performed, which demonstrated that for this study, the NanoTab System was statistically superior to IV PCA morphine for the PGA endpoint (p=0.009). This statistically superior PGA was also seen at the 24 hour and 72 hour time points. Additionally, the percentage of patients rating the NanoTab System as Excellent was higher than those rating IV PCA morphine as excellent (42.9% vs. 30.6%, p=0.016). Similar percentages of NanoTab System-treated and IV PCA morphine-treated patients dropped out of the study prematurely due to lack of efficacy (7.3% vs. 8.3% respectively) or due to an adverse event (7.9% vs. 11.1% respectively).  Full Article

AcelRx Pharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
Thursday, 6 Dec 2012 10:08pm EST 

AcelRx Pharmaceuticals Inc announced the pricing of its previously announced underwritten public offering of 12,500,000 shares of its common stock, offered at a price of $3.31 per share to the public. The gross proceeds to AcelRx from this offering are expected to be approximately $41.38 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 December 12, 2012, subject to the satisfaction of customary closing conditions. AcelRx has granted the underwriters a 30-day option to purchase up to an aggregate of 1,875,000 additional shares of common stock. Jefferies & Company, Inc. and Cowen and Company, LLC are acting as joint book-running managers for the proposed offering, with Canaccord Genuity Inc. acting as co-lead manager.  Full Article

AcelRx Pharmaceuticals Inc Announces Proposed Public Offering Of Common Stock
Wednesday, 5 Dec 2012 06:00am EST 

AcelRx Pharmaceuticals Inc announced a proposed underwritten public offering of 10,000,000 shares of its common stock pursuant to a registration statement filed with the Securities and Exchange Commission (SEC). AcelRx will grant the underwriters a 30-day option to acquire up an additional 1,500,000 shares to cover over-allotments, if any. All of the shares in the offering are to be sold by AcelRx. Jefferies & Company, Inc. and Cowen and Company, LLC are acting as joint book-running managers for the proposed offering, with Canaccord Genuity Inc. acting as co-lead manager.  Full Article

AcelRx Pharmaceuticals Inc Announces Achievement of the Primary End-Point in Phase 3 Comparative Study Involving the Sufentanil NanoTab PCA System
Wednesday, 14 Nov 2012 07:43pm EST 

AcelRx Pharmaceuticals Inc announced it had met the primary endpoint in the Phase 3 non-inferiority study of the sublingual Sufentanil NanoTab PCA System vs. IV PCA with morphine. The top-line data is expected to be released prior to market opening on November 15, 2012.  Full Article

AcelRx Pharmaceuticals Inc Receives Fourth and Fifth U.S. Patents For Small-Volume Oral Transmucosal Dosage Forms
Wednesday, 29 Aug 2012 07:30am EDT 

AcelRx Pharmaceuticals Inc announced that the U.S. Patent and Trademark Office (USPTO) has recently issued AcelRx Patent Number 8,252,328 entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery," and Patent Number 8,252,329 also entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery." The '328 and '329 patents each make claims to a bioadhesive tablet for oral transmucosal administration of sufentanil. These newly issued patents will provide intellectual property protection for sufentanil NanoTab based products until at least January 5, 2027.  Full Article

AcelRx Pharmaceuticals Inc Receives Two Additional U.S. Patents For Small-Volume Oral Transmucosal Dosage Forms
Wednesday, 1 Aug 2012 07:31am EDT 

AcelRx Pharmaceuticals Inc announced that the U.S. Patent and Trademark Office (USPTO) has recently issued AcelRx Patent Number 8,226,978 entitled "Small Volume Oral Transmucosal Dosage Forms Containing Sufentanil for Treatment of Pain, and Patent Number 8,231,900 entitled Small-Volume Oral Transmucosal Dosage Forms. The '978 patent claims a dosage form for oral transmucosal administration of sufentanil and the '900 patent claims a small-volume solid tablet containing a single dose of sufentanil for oral mucosal administration to a subject.  Full Article

AcelRx Pharmaceuticals Inc Completes Private Placement of $10.0 Million
Monday, 4 Jun 2012 07:30am EDT 

AcelRx Pharmaceuticals Inc announced that it completed its previously announced private placement of common stock and warrants to purchase common stock on June 1, 2012. Gross proceeds from the offering were approximately $10.0 million. Proceeds from the private placement are expected to be used for general corporate and working capital purposes, including the development of the ARX-01 Sufentanil NanoTab PCA System, AcelRx's lead product candidate for the treatment of post-operative pain.  Full Article

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