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April 8, 2014
07:04 EDTALKSAlkermes announces phase 3 'positive' results from aripiprazole lauroxil study
Alkermes announced "positive" topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale total scores at week 12, compared to placebo, which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application to the U.S. Food and Drug Administration in 3Q14. In addition to meeting the prespecified primary efficacy endpoint, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression-Improvement scale versus placebo at week 12. Aripiprazole lauroxil was generally well tolerated in the phase 3 study, and the safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache. Alkermes will present data from the phase 3 study at an upcoming medical meeting and submit the results for publication in a peer-reviewed journal.
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March 27, 2015
10:03 EDTALKSOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: AEGON (AEG) downgraded to Neutral from Buy at Goldman... Alkermes (ALKS) downgraded to Neutral from Buy at Citigroup... American Eagle (AEO) downgraded to Sell from Neutral at Goldman... ArcelorMittal (MT) downgraded to Sell from Neutral at Citigroup... Black Diamond (BDE) downgraded to Sell from Hold at Feltl... Diodes (DIOD) downgraded to Outperform from Strong Buy at Raymond James... EMC (EMC) downgraded at Pacific Crest... Epizyme (EPZM) downgraded to Neutral from Buy at Citigroup... FutureFuel (FF) downgraded Neutral at Roth Capital... GameStop (GME) downgraded to Neutral from Buy at B. Riley... MSC Industrial (MSM) downgraded to Neutral from Outperform at RW Baird... Pioneer Energy (PES) downgraded to Hold from Buy at Deutsche Bank... Power Integrations (POWI) downgraded to Market Perform at Raymond James... Precision Drilling (PDS) downgraded to Hold from Buy at Deutsche Bank... SanDisk (SNDK) downgraded to Hold from Buy at Evercore ISI... Semtech (SMTC) downgraded to Outperform from Strong Buy at Raymond James... Swiss Re (SSREY) downgraded to Hold from Buy at Jefferies... Vantiv (VNTV) downgraded at SunTrust... Vivendi (VIVHY) downgraded to Underperform from Outperform at Exane BNP Paribas... WESCO (WCC) downgraded to Neutral from Outperform at RW Baird... World Acceptance (WRLD) downgraded to Underperform from Neutral at Macquarie... Zurich Insurance (ZURVY) downgraded to Neutral from Buy at Goldman.
06:15 EDTALKSAlkermes downgraded to Neutral from Buy at Citigroup
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