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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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August 1, 2014
10:00 EDTFLMLOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Arista Networks (ANET) initiated with a Neutral at Citigroup... Casella Waste (CWST) initiated with a Hold at Stifel... CymaBay Therapeutics (CBAY) initiated with an Outperform at Cowen... Finish Line (FINL) initiated with a Buy at Jefferies... Flamel Technologies (FLML) initiated with an Outperform at Leerink... PTC Therapeutics (PTCT) initiated with an Outperform at Oppenheimer... Paramount Gold & Silver (PZG) initiated with a Buy at Noble Financial... Progressive Waste (BIN) initiated with a Hold at Stifel... Prosensa (RNA) initiated with an Outperform at Oppenheimer... Sangamo (SGMO) initiated with an Overweight at JPMorgan... Sarepta (SRPT) initiated with an Outperform at Oppenheimer... Sucampo (SCMP) initiated with a Buy at Roth Capital.
07:02 EDTFLMLFlamel Technologies initiated with an Outperform at Leerink
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July 29, 2014
07:07 EDTFLMLFlamel Technologies reports Q2 adjusted EPS (13c), consensus (9c)
Reports Q2 revenue $8.1M, consensus $9.77M.

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