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Stock Market & Financial Investment News

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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April 11, 2014
12:42 EDTFLMLOn The Fly: Analyst Initiation Summary
ASML (ASML) initiated with a Cautious at ISI Group... Analog Devices (ADI) initiated with a Buy at ISI Group... Applied Materials (AMAT) initiated with a Strong Buy at ISI Group... Aruba Networks (ARUN) initiated with a Buy at SunTrust... Broadcom (BRCM) initiated with a Neutral at ISI Group... CSX (CSX) initiated with an Outperform at Macquarie... Cisco (CSCO) initiated with a Buy at SunTrust... F5 Networks (FFIV) initiated with a Neutral at SunTrust... Genesee & Wyoming (GWR) initiated with a Neutral at Macquarie... Intel (INTC) initiated with a Neutral at ISI Group... Juniper (JNPR) initiated with a Buy at SunTrust... KLA-Tencor (KLAC) initiated with a Neutral at ISI Group... Lam Research (LRCX) initiated with a Strong Buy at ISI Group... Linear Technology (LLTC) initiated with a Cautious at ISI Group... Maxim Integrated (MXIM) initiated with a Neutral at ISI Group... Micron (MU) initiated with a Strong Buy at ISI Group... NVIDIA (NVDA) initiated with a Neutral at ISI Group... NXP Semiconductors (NXPI) initiated with a Strong Buy at ISI Group... Qualcomm (QCOM) initiated with a Strong Buy at ISI Group... Riverbed (RVBD) initiated with a Neutral at SunTrust... SanDisk (SNDK) initiated with a Neutral at ISI Group... Teradyne (TER) initiated with a Buy at ISI Group... Texas Instruments (TXN) initiated with a Neutral at ISI Group... Trulia (TRLA) initiated with a Neutral at Susquehanna... Union Pacific (UNP) initiated with a Neutral at Macquarie... Zillow (Z) initiated with a Positive at Susquehanna... Flamel Technologies (FLML) initiated with a Buy at Roth Capital... Parker Drilling (PKD) initiated with an Accumulate at Tudor Pickering.
08:52 EDTFLMLFlamel Technologies initiated with a Buy at Roth Capital
Target $20.
April 9, 2014
08:21 EDTFLMLFlamel Technologies initiated with a Buy at Summer Street
Target $25.
April 7, 2014
08:17 EDTFLMLFlamel Technologies to host conference call
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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.
April 2, 2014
06:33 EDTFLMLFlamel Technologies management to meet with SunTrust
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