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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.
News For FLML From The Last 14 Days
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January 22, 2015
06:55 EDTFLMLFlamel Technologies management to meet with SunTrust
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06:54 EDTFLMLFlamel Technologies management to meet with JMP Securities
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January 16, 2015
08:58 EDTFLMLFlamel Technologies price increase positive, says SunTrust
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January 15, 2015
12:26 EDTFLMLOn The Fly: Midday Wrap
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11:20 EDTFLMLFlamel Technologies announces price increase for Bloxiverz
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09:17 EDTFLMLFlamel Technologies weakness creates buying opportunity, says SunTrust
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08:47 EDTFLMLFlamel Technologies price target lowered to $17 from $22 at Roth Capital
Roth Capital cut its price target on Flamel (FLML) after the FDA approved Fresenius Kabi's (FMS) New Drug Application for neostigmine methylsulfate, a drug which Flamel currently markets as Bloxiverz. Roth expects eostigmine to become a two player market, but adds that price increases by Flamel could mitigate the negative impacts on Flamel's growth. The firm keeps a Buy rating on Flamel.
08:43 EDTFLMLFlamel Technologies pullback an overreaction, says Summer Street
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07:36 EDTFLMLFlamel Technologies sell-off yesterday overdone, says Leerink
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January 14, 2015
16:33 EDTFLMLOn The Fly: Closing Wrap
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14:10 EDTFLMLFlamel Technologies weakness a buying opportunity, says SunTrust
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13:17 EDTFLMLFlamel says evaluating options after Kabi's NDA approval
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12:49 EDTFLMLOn The Fly: Midday Wrap
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12:09 EDTFLMLFlamel Technologies plunges after Jazz gets favorable patent ruling
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