Key Developments: Acura Pharmaceuticals Inc (ACUR.O)

ACUR.O on Consolidated Issue listed on NASDAQ Capital Market

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Latest Key Developments (Source: Significant Developments)

Acura Pharmaceuticals Inc receives $2.5 million milestone payment from Egalet Corporation
Monday, 12 Oct 2015 06:30am EDT 

Acura Pharmaceuticals Inc:Says receipt of a $2.5 million milestone payment from Egalet Corporation triggered by the first commercial shipments of OXAYDO tablets, a product Egalet licensed from Acura.Says Acura's license agreement with Egalet provides for an additional one-time payment of $12.5 million when annual world-wide net sales of OXAYDO first reach $150 million in a calendar year.Acura will also receive a stepped royalty commencing on the first commercial sale at percentage rates from mid-single digits to double digits based on the level of OXAYDO world-wide net sales in a calendar year.  Full Article

Acura Pharmaceuticals to raise approximately $7.6 mln
Wednesday, 1 Jul 2015 06:15am EDT 

Acura Pharmaceuticals:To raise approximately $7.6 million from institutional healthcare investors.Entered into agreement with institutional investors to sell 9.8 million shares at $0.78 per share, payable at closing.After placement agent fees and estimated offering expenses payable by co, expects to receive net proceeds of about $7.05 million.Intends to use the net proceeds from the offering for general corporate purposes, funding product development and for general and administrative expenses.  Full Article

Acura Pharmaceuticals Inc enters license, development agreement with Bayer Healthcare
Tuesday, 16 Jun 2015 06:15am EDT 

Acura Pharmaceuticals Inc:Partners its methamphetamine resistant Impede(R) technology.Entered license and development agreement with Bayer healthcare to provide worldwide license to acura's impede technology.Says Bayer has the right to negotiate for a worldwide license to the impede technology for additional products.Agreement with Bayer healthcare to jointly develop product utilizing the impede technology for U.S. market.  Full Article

Acura Pharmaceuticals Inc reports successful topline results from Nexafed Extended-Release Clinical Study
Monday, 23 Mar 2015 06:00am EDT 

Acura Pharmaceuticals Inc:Says preliminary topline results from pilot clinical study which demonstrated bioequivalence of one formulation of NEXAFED (pseudoephedrine HCl) extended-release tablets to Sudafed 12-Hour Tablets.Says NEXAFED extended-release tablets utilize Acura's IMPEDE 2.0 enhanced methamphetamine-resistant technology.Acura intends to request pre- IND meeting with US Food and Drug Administration (FDA) to review this data and discuss complete development program.Study was conducted in 12 fasted, healthy subjects and measured the systemic absorption of active ingredient, pseudoephedrine, from a single dose each of two experimental NEXAFED extended-release formulations compared to Sudafed 12-Hour tablets.NEXAFED formulation B met FDA's standards for bioequivalence for maximum plasma concentration (Cmax) and extent of absorption (AUC).NEXAFED formulation A met bioequivalence criteria for extent of absorption but was low for maximum plasma concentration.  Full Article

Acura Pharmaceuticals Inc initiates clinical study of Meth-Resistant Nexafed Extended-Release Formulations
Monday, 16 Feb 2015 06:30am EST 

Acura Pharmaceuticals Inc:Announced the initiation of treatment in a pilot clinical study of two experimental formulations of NEXAFED (pseudoephedrine HCl) extended-release tablets employing Acura's 2 nd generation methamphetamine resistant technology, IMPEDE 2.0.Says the study in fasted, healthy subjects will measure the systemic absorption of the active ingredient, pseudoephedrine, from two experimental NEXAFED extended-release formulations compared to an FDA-approved 12-hour extended-release reference product.Says objective of the study is to characterize the bioavailability profile of the NEXAFED formulations for possible adjustment before pivotal human pharmacokinetic testing is undertaken.  Full Article

Acura Pharmaceuticals Inc submits formal dispute resolution request with FDA regarding Hydrocodone Bitartrate With Acetaminophen Tablets
Monday, 15 Sep 2014 06:00am EDT 

Acura Pharmaceuticals Inc:Says it has submitted a formal dispute resolution request with the FDA for Vycavert, its abuse deterrent formulation of hydrocodone and acetaminophen tablets.The dispute pertains to the FDA's determination that nasal snorting abuse of hydrocodone with acetaminophen products lacks relevance.By taking this action, Acura is availing itself of the FDA's established appeal process whereby disagreements with conclusions reached by a reviewing Division within the FDA are reviewed above the Division level.FDA guidance stipulates that the FDA respond within 30 days.  Full Article

Acura Pharmaceuticals Inc provides update on FDA discussions surrounding development of Aversion Hydrocodone With Acetaminophen Tablet
Friday, 15 Aug 2014 06:15am EDT 

Acura Pharmaceuticals Inc:Says preliminary discussions from meeting held with U.S. Food and Drug Administration (FDA) regarding development pathway for Acura's AVERSION hydrocodone with acetaminophen tablet development candidate.Says which is intended to provide abuse-deterrent features to address abuse by nasal snorting and injection.Says in a May letter to Acura, FDA questioned relevance of abuse of hydrocodone with acetaminophen products by nasal snorting after reviewing clinical and epidemiology data submitted by Acura.Says FDA continues to question the relevance of abuse of hydrocodone with acetaminophen products by the intranasal route of administration and suggested additional information may help better inform their decision.Says FDA indicated in discussions that Acura may conduct additional nasal abuse liability study for its AVERSION hydrocodone with acetaminophen product candidate.Says outcomes of which may help inform relevance decision as well as establish reduction in drug liking, which was not statistically significant in an earlier Acura study (Study AP-ADF-301).Says FDA requested further time to deliberate on the issues discussed during the meeting before issuing final meeting minutes.  Full Article

Acura Pharmaceuticals Inc provides update on its abuse deterrent Hydrocodone/Acetaminophen combination drug
Tuesday, 27 May 2014 05:00pm EDT 

Acura Pharmaceuticals Inc:Says US Food and Drug Administration (FDA) advised Company that data from intranasal abuse liability study AP-ADF-301 (Study 301) for AVERSION hydrocodone bitartrate with acetaminophen (hydrocodone/APAP) product candidate are insufficient to support an intranasal abuse deterrence claim.Study 301 failed to achieve a statistically significant reduction in Drug Liking (also known as Emax).Acura previously submitted report to FDA on prevalence of abusing hydrocodone products by intranasal administration and intends to meet with the FDA to discuss the FDA's expectations in this area.  Full Article

Acura Pharmaceuticals Inc announces settlement of patent litigation with Sandoz Inc
Wednesday, 21 May 2014 04:15pm EDT 

Acura Pharmaceuticals Inc:Enters into Settlement Agreement with Sandoz Inc. to settle Acura's patent infringement action pending against Sandoz in the United States District Court for the District of Delaware.In the suit, Acura alleges that generic of Acura's AVERSION oxycodone product, previously marketed by Pfizer Inc. under its brand name OXECTA.For which Sandoz is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA) infringes a U.S. patent owned by Acura.Under Sandoz Settlement Agreement, Sandoz may launch its generic to the AVERSION oxycodone product in the U.S., through the grant of a non-exclusive license from Acura to Sandoz.In certain circumstances, Acura's license to Sandoz would become effective prior to such time.  Full Article

Acura Pharmaceuticals Inc announces settlement of patent litigation with Ranbaxy Inc
Thursday, 8 May 2014 06:30am EDT 

Acura Pharmaceuticals Inc:It has entered into settlement agreement with Ranbaxy Inc.To dismiss, without prejudice, its patent infringement action pending against Ranbaxy in US District Court for District of Delaware.Says suit, Acura alleges that generic of Acura's AVERSION oxycodone product, previously marketed by Pfizer Inc.Settlement agreement provides that Ranbaxy's current product that is subject of its ANDA does not infringe Acura's Orange Book listed patents with FDA.Acura has not provided Ranbaxy with license to Acura's patents and Acura may re-commence patent infringement litigation against Ranbaxy if Ranbaxy changes formulation of its generic to AVERSION oxycodone product.  Full Article

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Exclusive: With luxury Acura makeover, Honda aims for brand survival, China revival

BEIJING As part of a broader makeover, and even the survival, of its stalled luxury Acura brand, Japan's Honda Motor Co will launch a new small crossover sport utility vehicle this year in China to compete with BMW and Audi in the world's biggest car market, two individuals closely involved in the effort said.

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