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June 18, 2014
07:03 EDTALKSAlkermes presents aripiprazole lauroxil phase 3 data
Alkermes announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil at the American Society of Clinical Psychopharmacology Annual Meeting. In the pivotal study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. This is the first demonstration of the efficacy of a range of doses of a long-acting injectable form of aripiprazole in a randomized clinical trial. The company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration in 3Q14. Aripiprazole lauroxil was generally well tolerated in the study, and the observed 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.
News For ALKS From The Last 14 Days
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September 22, 2015
08:00 EDTALKSJefferies sees buying opportunities in select biotech names
Analysts at Jefferies say their Washington D.C. consultants indicate the recent political rhetoric around drug pricing is unlikely to result in any substantive future policy changes that would impact biotech sector fundamentals. As such, they recommend using yesterday's selloff to buy select companies including Celgene (CELG), BioMarin (BMRN) and Alkermes (ALKS). Pricing concerns are nothing new, and will likely continue to be a headwind for the sector, the analysts tell investors in a research note. Hillary Clinton's proposal to combat drug pricing is likely to include "some combination of old and tried policies that have been out there for a few years," they write. The analysts also like shares of AMAG Pharmaceuticals (AMAG), Alder Biopharmaceuticals (ALDR) and Cempra (CEMP). The Jefferies Biotechnology research team is led by Brian Abrahams, Eun Yang and Biren Amin.
September 21, 2015
13:17 EDTALKSRBC reminds biotech investors that Republicans still control Congress
RBC Capital analyst Michael Yee notes that biotech indices are under pressure after Hillary Clinton tweeted about an upcoming plan to fight specialty drug pricing. The news follows a Wall Street Journal story about a private company dramatically increasing the price of their drug and another confirmed progressive multifocal leukoencephalopathy case for Biogen (BIIB), Yee tells investors in an intraday research note. Next year's election is likely to turn up the noise around drug pricing, creating headline risk for the biotech space, the analyst cautions. However, he reminds investors that Republicans control Congress, making it unlikely that "anything material" will get signed into law. Biotech names moving lower in today's trading include Biogen, AbbVie (ABBV), Gilead (GILD), Alkermes (ALKS), BioMarin (BMRN), Amicus (FOLD) and PTC Therapeutics (PTCT).

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