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News Breaks
April 7, 2014
07:36 EDTFLMLFlamel announces positive results of FIM clinical trial with Micropump
Flamel Technologies announced that its First-in-Man, or FIM, clinical study in healthy volunteers using its proprietary Micropump technology applied to sodium oxybate has identified formulations that demonstrate the potential to eliminate the second nighttime dose for patients suffering from narcolepsy achieved the objective of one single dose before bedtime for patients suffering from narcolepsy, eliminating the need for a second dose. The current dosing regimen for the standard of care, Xyrem, in the United States is two equal, divided doses: the first dose at bedtime and the second dose 2.5 to 4 hours later. The elimination of the second dose for narcolepsy patients would not only provide more convenience, but may improve the benefit sodium oxybate provides as there will be no disruption to nighttime sleep. The potential for additional benefits, including improved safety, will be studied.
News For FLML From The Last 14 Days
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March 27, 2015
08:40 EDTFLMLFlamel announces positive results of LiquiTime guaifenesin clinical trial
Flamel announced the results of a First-in-Man, or FIM, clinical study in healthy volunteers using its proprietary LiquiTime drug delivery platform applied to guaifenesin, a broadly used expectorant. LiquiTime is designed to provide a controlled, extended release of oral liquids principally for pediatric and geriatric patients. The company conducted a 16-subject four-way crossover pharmacokinetic study in healthy volunteers evaluating three different BID formulations of LiquiTime guaifenesin against immediate release guaifenesin tablets dosed every 4 hours. The trial was intended to provide sufficient data for the Company to choose the best prototype to move forward into a pivotal study. While none of the prototype formulations in this relatively small pilot study exactly satisfied all of the criteria necessary for proving bioequivalence of AUC to the immediate release guaifenesin tablets under FDA requirements, the results clearly met the intention of the study. The chosen formulation will be optimized and scaled up over the coming months and Flamel plans to perform a pivotal study in 2016. There were no safety issues raised during the study. LiquiTime is protected by the company's intellectual property through late 2025 in the United States and through early 2023 in Europe.
March 20, 2015
07:21 EDTFLMLFlamel price target raised to $27 from $21 at Leerink
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March 19, 2015
14:36 EDTFLMLFlamel price target raised to $21 from $17 at Roth Capital
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08:10 EDTFLMLFlamel backs FY15 revenue guidance of $170M-$185M, consensus $189.58M
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08:08 EDTFLMLFlamel reports Q4 EPS (69c), may not compare to consensus (17c)
Reports Q4 revenue $2.97M vs. $968,000 last year.

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