Key Developments: ACADIA Pharmaceuticals Inc (ACAD.O)

ACAD.O on Nasdaq

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27 Feb 2015
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Latest Key Developments (Source: Significant Developments)

Faruqi & Faruqi, LLP Launches Investigation Against Acadia Pharmaceuticals Inc For Potential Breaches Of Fiduciary Duties By Board Of Directors
Friday, 10 May 2013 06:45pm EDT 

Juan E. Monteverde, a partner at Faruqi & Faruqi, LLP, a national securities firm headquartered in New York City, is investigating the Board of Directors of ACADIA Pharmaceuticals Inc. for potential breaches of fiduciary duties in connection with their conduct in seeking shareholders' approval for an amendment to the Company's 2010 Equity Incentive Plan. Specifically, in the Proxy Statement filed by the Company with the Securities and Exchange Commission on April 25, 2013, the Board of Directors recommends that ACADIA's shareholders vote to approve an amendment to the Company's 2010 Equity Incentive Plan to increase the aggregate number of shares of common stock authorized for issuance under the plan by 7,500,000 shares. The issuance of the additional shares could have a substantial dilutive effect on the shares of ACADIA common stock.  Full Article

Acadia Pharmaceuticals Inc Announces Expedited Path To NDA Filing For Pimavanserin Following Meeting With FDA
Thursday, 11 Apr 2013 07:00am EDT 

Acadia Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application (NDA) for the treatment of Parkinson's disease psychosis (PDP). As a result, ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month. ACADIA is currently focused on completing the remaining elements of pimavanserin PDP development program that are needed for submission of an NDA. These include customary supportive studies, such as drug-drug interaction studies, and CMC development, such as stability testing of registration batches. Subject to changes that could result from future interactions with the FDA or other developments, ACADIA is currently targeting an NDA submission near the end of 2014.  Full Article

Acadia Pharmaceuticals Inc Announces Presentation of Data from Its Pivotal Phase III Parkinson’s Disease Psychosis Study with Pimavanserin at the American Academy of Neurology Annual Meeting
Wednesday, 20 Mar 2013 10:00pm EDT 

Acadia Pharmaceuticals Inc announced detailed results from its pivotal Phase III -020 Study with pimavanserin in patients with Parkinson`s disease psychosis at the Emerging Science session of the 65th American Academy of Neurology (AAN) Annual Meeting. The analysis of the full data set from the Phase III -020 Study showed robust and consistent efficacy of pimavanserin across a wide array of study measures and confirmed the positive top-line results previously reported. Pimavanserin met the primary endpoint in the -020 Study by demonstrating highly significant antipsychotic efficacy on the 9-item SAPS-PD scale (p=0.001). Pimavanserin also met the key secondary endpoint for motoric tolerability as measured using Parts II and III of the Unified Parkinson`s Disease Rating Scale, or UPDRS. Dr. Cummings presented new data from the -020 Study showing highly significant improvements in all secondary efficacy measures, including the Clinical Global Impression Severity, or CGI-S, scale (p <0.001), the Clinical Global Impression Improvement, or CGI-I, scale (p=0.001), and a CGI-I responder analyses (p=0.002). The CGI-I responder results showed that approximately twice as many subjects in the pimavanserin treatment arm, as compared to placebo, were rated as very much improved or much improved at the conclusion of the study.  Full Article

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