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News Breaks
October 18, 2012
08:33 EDTFLMLFlamel announces FDA acceptance of NDA for undisclosed hospital-based product
Flamel Technologies SA announced that the U.S. FDA has accepted the company's New Drug Application, or NDA, for an undisclosed hospital-based product. Flamel has received a Prescription Drug User Fee Act, or PDUFA, date, the target date for the FDA to complete its review of the NDA, of May 31, 2013. For competitive reasons, the Company has decided not to identify the product at this time, but intends to provide additional information at a later date. Flamel believes that the product could have a significant impact on the company's revenue generation and favorably impact its progression to profitability. If approved by the FDA, the product is expected to generate approximately $25M-$35M or more in peak annual revenues, subject to the company being able to market and price the product successfully, of which there can be no assurance.
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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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