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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.
News For ALKS From The Last 14 Days
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July 31, 2015
07:31 EDTALKSAlkermes reported solid Q2 financial results, says Leerink
Leerink analyst Michael Schmidt says Alkermes reported solid Q2 financial results driven by stronger than expected Vivitrol sales. All pipeline programs remain on track, Schmidt tells investors in a post-earnings research note. He reiterates an Outperform rating on the stock with a $79 price target.
July 30, 2015
13:06 EDTALKSAlkermes remains well positioned after Q2 results, says JPMorgan
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07:12 EDTALKSAlkermes raises FY15 adjusted EPS view to (31c)-(45c) from (37c)-(50c)
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07:10 EDTALKSAlkermes reports Q2 adjusted EPS (9c), consensus (10c)
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July 29, 2015
15:08 EDTALKSNotable companies reporting before tomorrow's open
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13:54 EDTALKSEarnings Watch: Alkermes up around 17% since last earnings report
Alkermes (ALKS) is scheduled to report second quarter earnings before the market open on Thursday, July 30 with a conference call scheduled for 8:30 am ET. Alkermes, an integrated biopharmaceutical company, engages in the research, development, and commercialization of pharmaceutical products to address unmet medical needs of patients in various therapeutic areas. EXPECTATIONS: Analysts are looking for a loss of (10c) per share on revenue of $142.8M, according to First Call. The consensus range for EPS is for a loss of (17c)-(4c) on revenue of $134.5M-$153.28M. LAST QUARTER: Alkermes reported first quarter EPS of 6c, compared to a consensus estimate of a loss of (3c), on revenue of $161.2M against estimates of $146.6M. The company reiterated all of its financial expectations for 2015 that it had previously given on March 9, when it cut its 2015 EPS view to (37c)-(50c) from (27c)-(40c). Q1 revenue from the company's anti-psychotic franchise, including Risperdal were $46.9M, compared to $49.6M for the same period in the prior year. Revenues from Amprya/Famprya were $36.5M, compared to $20.6M for the same period in the prior year. "Our results this quarter reflect strong revenues from our portfolio of key commercial products and focused investment in our promising late-stage pipeline of CNS product candidates that will drive our future growth," commented Alkermes CFO James Frates. Alkermes CEO Richard Pops noted that the company is on the "threshold" of its next growth phase and that Aripiprazole lauroxil, the company's long-acting atypical anti-psychotic for schizophrenia, is moving toward FDA approval and launch later this year. STREET RESEARCH: On June 26, Cowen said the clinical profile for Alkermes' ALKS 3831 continues to look interesting, as the firm's consultants believe data for the drug suggests a profile that would provide a significant benefit over Zyprexa for the treatment of schizophrenia. Cowen reiterated its Outperform rating and $80 price target on Alkermes shares. PRICE ACTION: Alkermes shares are up around 17% since the company's last earnings report on April 30, and are down almost 3% to $67.40 in midday trading ahead of Thursday's earnings release.
July 27, 2015
10:40 EDTALKSLeerink major pharma analyst holds an analyst/industry conference call
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