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Flamel Technologies Completes Cross-Border Merger and Becomes Avadel Pharmaceuticals plc
GlobeNewswire•January 3, 2017
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DUBLIN, Ireland, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Flamel Technologies SA, completed its previously announced cross-border merger with and into its wholly-owned Irish subsidiary, Avadel Pharmaceuticals plc (NASDAQ:AVDL) (Avadel), effective January 1, 2017, with Avadel surviving the merger as the public holding company. As a result of the merger, all of Flamel’s outstanding ordinary and American Depository Shares (ADSs) were canceled and exchanged on a one-for-one basis for Avadel ordinary shares and ADSs, respectively. Avadel ADSs will begin trading on the NASDAQ Global Market under trading symbol “AVDL” on January 3, 2017.
Michael Anderson, Avadel’s Chief Executive Officer, remarked, “We are excited to enter 2017 as Avadel. The completion of the cross-border merger from France to Ireland serves as a way to unify our subsidiaries under a shared corporate identity, and provides the company with a new set of corporate governance policies that will allow us greater flexibility as we continue to grow our business and commercialize products.”
Mr. Anderson continued, “Our new name, Avadel, which stands for ‘advanced delivery,’ was born out of our company’s strong history in drug delivery and serves as a constant reminder of a key piece of our company’s growth strategy – to develop differentiated pharmaceutical products utilizing our proprietary and innovative technologies.”
“We are excited to begin 2017 with a new name, an ongoing Phase III trial and a strong financial position,” finished Mr. Anderson.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a specialty pharmaceutical company that seeks to develop differentiated pharmaceutical products that are safe, effective and easy to take through formulation development, by utilizing its proprietary drug delivery technology and in-licensing / acquiring new products; ultimately, helping patients adhere to their prescribed medical treatment and see better results. Avadel currently markets products in the hospital and primary care spaces. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For more information, please visit www.avadel.com
Flamel Technologies Reaches Agreement With FDA on Protocol for Phase III Pivotal Trial of FT218
[Marketwired]
October 6, 2016
LYON, FRANCE--(Marketwired - Oct 6, 2016) - Flamel Technologies ( NASDAQ : FLML ) today announced that its Irish subsidiary, Flamel Ireland Holdings, has reached agreement with the U.S. Food and Drug Administration (FDA) for the design and planned analysis of a Phase III clinical trial of FT218, a once nightly formulation of sodium oxybate utilizing the Company's proprietary drug delivery platform, Micropump®. The agreement was reached through the Special Protocol Assessment (SPA) process.
A SPA is an acknowledgement by FDA that the design and planned analysis of the Company's pivotal clinical trial of FT218 adequately addresses the objectives necessary to support a regulatory submission. The Phase III trial, titled "A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy," recently commenced patient enrollment in Canada, with sites in Europe and the U.S. to be initiated near-term.
Mike Anderson, Chief Executive Officer of Flamel, remarked, "We are thrilled to announce that we have come to a much anticipated agreement with FDA on our SPA for a pivotal study of FT218, Micropump® sodium oxybate. This is a major milestone for the trial, as we move forward with site initiation in Europe and subsequently, the United States. We believe our once nightly formulation of sodium oxybate has the potential to offer significant improvements over the current standard of care, in addition to meaningful improvement in overall quality of life for patients suffering from narcolepsy."
About Sodium Oxybate
Sodium Oxybate is the sodium salt of gamma hydroxybutyrate, an endogenous compound and metabolite of the neurotransmitter gamma-aminobutyric acid (GABA). It has been described as a therapeutic agent with high medical value; in Europe and the United States it is currently approved in a twice nightly formulation indicated for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy at doses up to 9g/night.
Jazz Makes Deal In Xyrem IP Fight With Ranbaxy, Sun, Ohm
By Kevin Penton
Law360, New York (May 13, 2016, 9:52 PM ET) -- Jazz Pharmaceuticals Inc. has agreed to drop its claims against generic-drug makers Ranbaxy, Sun and Ohm in a patent infringement case involving the narcolepsy drug Xyrem after the companies resolved their differences and struck a licensing agreement, the company told a New Jersey federal judge Thursday.
Ranbaxy Inc., Sun Pharmaceutical Industries Ltd. and Ohm Laboratories Inc. stipulated as part of the proposed order sent to U.S. District Judge Esther Salas that the abbreviated new drug applications they filed for a proposed generic version of Xyrem was a technical act of infringement of each of the asserted patents in the case and that their manufacturing and sales of the proposed generic would also infringe. The filing did not give details of the agreement.
Other than what the May 9 licensing deal allows, Ranbaxy, Sun and Ohm agreed not to manufacture or to sell the generic drug during the life of the patents, according to the letter.
Counsel for the parties could not be reached for comment on Friday.
Jazz began suing Ranbaxy and other drugmakers in 2013, alleging that their planned generic versions of Xyrem would infringe several of its patents, including those covering the composition of the drug and the method of distributing it. Other defendants include Amneal Pharmaceuticals, Par Pharmaceutical Inc. and Watson Laboratories Inc.
The suits came in response to ANDAs filed by each of the defendants seeking approval to commercially market a generic version of Xyrem before the expiration of various patents held by Jazz concerning the drug, which is used to treat daytime sleepiness and muscle weakness in narcolepsy patients.
The active ingredient in Xyrem is GHB, an intoxicant that the U.S. Drug Enforcement Agency has labeled a date-rape drug. Because of the risk of abuse, Xyrem is only available through one central pharmacy to patients who undergo special training on how to use it.
Several of the generics makers have alleged that the patents are invalid, saying they claim only the abstract idea of controlling access to a prescription drug to guard against potential abuse.
U.S. Magistrate Judge Joseph A. Dickson consolidated five related complaints in January.
Jazz is represented by Charles M. Lizza, William C. Baton and Sarah A. Sullivan of Saul Ewing LLP and Frank C. Calvosa, Brian J. Forsatz and Catherine T. Mattes of Quinn Emmanuel Urquhart & Sullivan LLP.
Ranbaxy, Sun and Ohm are represented by Karen A. Confoy, Christopher R. Kinkade and Kai W. Marshall-Otto of Fox Rothschild LLP and William Zimmerman, Carol Pitzel Cruz, Ben Anger, Karen Cassidy, and Christie Matthaei of Knobbe Martens Olson & Bear LLP.
The case is Jazz Pharmaceuticals Inc. v. Amneal Pharmaceuticals LLC et al., case number 2:13-cv-00391, in the U.S. District Court for the District of New Jersey.
--Additional reporting by Alex Wolf. Editing by Brian Baresch.
All Content © 2003-2016, Portfolio Media, Inc.
At $10 pps MarCap seems far more reasonable v summer highs of mid-$20's.
They have delivered on bringing product to market and partnerships. PDUFA April 30, 2016. Some risk due to the bearish biotech market (obviously), but as a trade I'll take a gamble here.
$10.22 close on Fri
Flamel Ireland Limited Licenses LiquiTime(R) Technology to Perrigo for U.S. Over-the-Counter Market
Related Quotes LYON, FRANCE--(Marketwired - Oct 5, 2015) - Flamel Technologies (NASDAQ: FLML) announced today that the Company's Irish subsidiary, Flamel Ireland Limited, has licensed exclusive U.S. rights to the LiquiTime® drug delivery platform to Perrigo's Irish subsidiary, Elan Pharma International Limited, for the U.S. Over-the-Counter (OTC) drug market. LiquiTime® is Flamel's drug delivery platform for modified, extended and controlled release of liquid oral drugs.
Flamel has entered into a multi-product agreement for extended release liquid OTC products in the U.S. market whereby Flamel will receive an upfront payment of $6.0 million and will be eligible for at least $50 million in approval and launch milestones for a minimum of seven products. In addition, Flamel will receive mid-single digit royalties on net sales. The exclusive license includes Flamel's LiquiTime® Ibuprofen and LiquiTime® Guaifenesin oral suspensions.
Flamel and Perrigo believe there is a large market opportunity for other OTC extended release liquid drug formulations, including products containing active ingredient combinations for the US cough/cold market, which analysts have estimated at $6.5 billion annually.
"We are very pleased to partner with Perrigo, one of the premier companies in the US Over-the-Counter consumer goods market. Flamel's LiquiTime® platform meets the unmet medical need for patients who are seeking the convenience of extended release liquid OTC medications. In addition, our LiquiTime® drug delivery platform is patent protected through September 2025 in the US and we will have the ability to apply for product-specific patents to extend those periods of patent protection," said Michael S. Anderson, Chief Executive Officer.
"This licensing agreement with Perrigo is another important validation of the quality and differentiation of Flamel's drug delivery platform technology. Moreover, we are pleased to accomplish one of our major commitments to investors in 2015 by putting these products into the hands of a leading OTC consumer products company that may result in an attractive set of milestone and royalty payments to our Company over time.
Neostigmine $0.80 vs $0.08 generic; our hospital dumped these guys. Cant imagine anyone paying that.
$FLML recent news/filings
bullish
quick trade
resistance breakout
## source: finance.yahoo.com
Mon, 06 Apr 2015 22:20:22 GMT ~ Nasdaq stocks posting largest percentage increases
[AP] - A look at the 10 biggest percentage gainers on Nasdaq at the close of trading: Tonix Pharma rose 26.5 percent to $7.40. Trillium Therapeutic rose 16.4 percent to $11.12. Ebix Inc. rose 14.3 percent to ...
read full: http://sg.finance.yahoo.com/news/nasdaq-stocks-posting-largest-percentage-220237991--finance.html
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Thu, 02 Apr 2015 12:36:12 GMT ~ Egalet (EGLT) in Focus: Stock Plunges 11.5% - Tale of the Tape
read full: http://finance.yahoo.com/news/egalet-eglt-focus-stock-plunges-123612484.html
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Wed, 01 Apr 2015 12:37:12 GMT ~ ImmunoGen (IMGN) in Focus: Stock Rises 5.1% in Session - Tale of the Tape
read full: http://finance.yahoo.com/news/immunogen-imgn-focus-stock-rises-123712451.html
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Wed, 01 Apr 2015 12:30:12 GMT ~ Rigel Pharmaceuticals (RIGL) Looks Good: Stock Up 6.6% - Tale of the Tape
read full: http://finance.yahoo.com/news/rigel-pharmaceuticals-rigl-looks-good-123012220.html
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Fri, 27 Mar 2015 12:56:06 GMT ~ Flamel Technologies Announces Positive Results of a First-in-Man Clinical Trial with LiquiTime Guaifenesin
[at noodls] - Flamel Technologies Announces Positive Results of a First-in-Man Clinical Trial with LiquiTime® Guaifenesin Registration Trial in the United States to be Performed in 2016 Lyon, France - March 27, 2015 ...
read full: http://www.noodls.com/view/C9993FE9BB8C94A24A36985ED7C55B3ECBA266AC
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$FLML charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$FLML company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/FLML/company-info
Ticker: $FLML
OTC Market Place: Not Available
CIK code: 0001012477
Company name: Flamel Technologies S.A.
Company website: http://www.flamel-technologies.fr
Incorporated In:
$FLML share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: No Par Value
$FLML extra dd links
Company name: Flamel Technologies S.A.
Company website: http://www.flamel-technologies.fr
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/FLML/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/FLML/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=FLML+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=FLML+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=FLML+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/FLML/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/FLML/news - http://finance.yahoo.com/q/h?s=FLML+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/FLML/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/FLML/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/FLML/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/FLML/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/FLML/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/FLML/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/FLML/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/FLML/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=FLML+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/FLML
DTCC (dtcc.com): http://search2.dtcc.com/?q=Flamel+Technologies+S.A.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Flamel+Technologies+S.A.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Flamel+Technologies+S.A.&x=0&y=0
WHOIS (domaintools.com): http://whois.domaintools.com/http://www.flamel-technologies.fr
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.flamel-technologies.fr#
Corporate website internet archive (archive.org): http://web.archive.org/web/*/http://www.flamel-technologies.fr
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/FLML/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/FLML
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/FLML/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/FLML/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/FLML/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001012477&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/FLML/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/FLML/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/FLML/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/FLML/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=FLML&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=FLML
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/FLML/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=FLML+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=FLML+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=FLML
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=FLML
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=FLML+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/FLML/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=FLML+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/FLML.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=FLML
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/FLML/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/FLML/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/FLML/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/FLML/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/FLML
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/FLML
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/FLML:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=FLML
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=FLML
$FLML DD Notes ~ http://www.ddnotesmaker.com/FLML
No one here but us chickens...
and that's just the way I like it!
:)
I've been reading up on this one...
here's another tidbit to add to what you've posted
"Deerfield’s stake in French-based Flamel Technologies S.A. (ADR) (NASDAQ:FLML) remained unchanged over the quarter at 5.26 million shares worth $90.08 million. The stock of the biopharmaceutical company gained 20% in the last quarter of 2014, but since the beginning of the year it fell by 9%. During the fourth quarter, Flamel Technologies S.A. (ADR) (NASDAQ:FLML) has attracted more interest from investors as the number of funds holding the stock increased to 27 which held around $284.33 million worth of the company’s stock, versus 18 funds holding $223.26 million of stock in the previous quarter. Broadfin Capital is also a shareholder of Flamel Technologies S.A. (ADR) (NASDAQ:FLML), disclosing ownership of 5.15 million shares in its last 13F filing."
Read more at http://www.insidermonkey.com/blog/auspex-pharmaceuticals-inc-aspx-horizon-pharma-plc-hznp-deerfield-management-keeps-betting-on-pharmaceuticals-and-biotech-339694/2/#oJBldKX7rU7oEuov.99
Flamel Technologies Announces Positive Results of a Second Clinical Trial With Micropump(R) Sodium Oxybate
Results Confirm Elimination of the "Middle-of-the-Night Dose" Achieved in Previous Study Meeting With FDA Will Be Requested in the First Quarter of 2015
LYON, FRANCE--(Marketwired - Dec 19, 2014) - Flamel Technologies (NASDAQ: FLML) today announced that its second clinical study in healthy volunteers using its proprietary Micropump® technology applied to sodium oxybate has achieved the objective of one single dose before bedtime for patients suffering from narcolepsy, confirming the results of a previous, first-in-man, study. The current dosing regimen for the standard of care, Xyrem® (sodium oxybate), 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.
The trial was designed as a 2-arm study with 12 patients in each arm evaluating two different formulations of Micropump® sodium oxybate at a nightly dose of 4.5g, 6g and 7.5g. Each subject consumed a standard meal two hours prior to dosing. Subjects were instructed to maintain a consistent meal time and dosing schedule throughout the study. One subject dropped out of the study prior to the completion of the 7.5g dosing portion for reasons unrelated to drug. The data for both formulations at the 4.5g and 6g doses were consistent with the data seen in the previous study which showed:
Onset of action similar to Xyrem
Cmax lower than Xyrem
Mean blood concentration (ug/ml) at hours 7 and 8 similar to Xyrem
The data at the 7.5g dose for both formulations were consistent with expectations given the data generated at the lower doses. While both formulations were successful, Flamel has chosen to move forward with the optimal formulation.
To date, Micropump® sodium oxybate has been tested in 40 healthy subjects across three doses among three different formulations with no safety or tolerability issues.
Flamel plans to meet with the U.S. Food and Drug Administration (FDA) before the middle of 2015. Based on current expectations, the Company plans to begin registration studies prior to the end of 2015.
Flamel's Micropump technology is protected by intellectual property through at least 2025 in the United States. Micropump is a proven drug delivery platform for the oral delivery of small molecules.
Narcolepsy is a sleep disorder involving irregular patterns in Rapid Eye Movement (REM) sleep and significant disruptions of the normal sleep/wake cycle. People with narcolepsy experience excessive daytime sleepiness, sleep attacks, cataplexy, sleep paralysis, hallucinations and disrupted nighttime sleep.
Xyrem® is sold in the United States by Jazz Pharmaceuticals plc, in Canada by Valeant Canada Limited (via license from Jazz) and in twenty-two EU countries and Mexico by UCB Pharma Limited (via license from Jazz).
About Flamel Technologies - Flamel Technologies SA's (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The Company markets Bloxiverz® (neostigmine methylsulfate) and Vazculep™ (phenylephrine hydrochloride) in the US and licenses the Micropump-based microparticles technology to Recipharm AB for application to the manufacturing under FDA-audited GMP guidelines of Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its pipeline includes chemical and biological drugs formulated with its Micropump® (and its applications to the development of liquid formulations LiquiTime® and of abuse-deterrent formulations Trigger Lock™) and Medusa™ proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and Dublin, Ireland. Additional information may be found at www.flamel.com.
$JAZZ $FLML Canaccord Provides Input Into Jazz’s Patent Fight Against Flamel On Xyrem http://www.smarteranalyst.com/2014/10/03/canaccord-provides-input-jazzs-patent-fight-flamel-xyrem/
$FLML Roth Capital Recommends Purchase Flamel Shares Ahead Of Improving Fundamentals http://www.smarteranalyst.com/2014/08/20/roth-capital-recommends-purchase-flamel-shares-ahead-of-improving-fundamentals/
Flamel Technologies S.A. [$FLML] due diligence
bullish
$FLML
DD Notes ~ http://www.ddnotesmaker.com/FLML
##### recent news/filings ~ source: finance.yahoo.com
Thu, 03 Jul 2014 21:15:55 GMT ~ Nasdaq stocks posting largest percentage increases
read full: http://sg.finance.yahoo.com/news/nasdaq-stocks-posting-largest-percentage-220237991--finance.html
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Thu, 03 Jul 2014 05:10:32 GMT ~ Flamel Technologies Announces Results of 2014 Annual Meeting
[at noodls] - LYON, FRANCE--(Marketwired - Jul 2, 2014) - Flamel Technologies S.A. (NASDAQ: FLML) today announced voting results from the Company's annual ordinary and extraordinary meeting held on June 24, 2014. Approximately ...
read full: http://www.noodls.com/view/659974D931B1FAC0194E7FC8DBD47BBB3A1206C1
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Wed, 02 Jul 2014 20:00:00 GMT ~ Flamel Technologies Announces Results of 2014 Annual Meeting
[Marketwired] - Flamel Technologies S.A. today announced voting results from the Company's annual ordinary and extraordinary meeting held on June 24, 2014. Approximately 97 percent of outstanding shares were represented ...
read full: http://finance.yahoo.com/news/flamel-technologies-announces-results-2014-200000088.html
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Mon, 30 Jun 2014 13:17:29 GMT ~ Monday’s Top Biotech Stories: MannKind, Dicerna, Flamel, and Merck
read full: http://www.fool.com/investing/general/2014/06/30/mondays-top-biotech-stories-mannkind-dicerna-flame.aspx?source=eogyholnk0000001
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Mon, 30 Jun 2014 11:00:00 GMT ~ Flamel Technologies Announces FDA Approval of VAZCULEP
[Marketwired] - Flamel Technologies today announced that the U.S. Food and Drug Administration has approved the company's New Drug Application for VAZCULEP™ . VAZCULEP Injection is an alpha-1 adrenergic receptor agonist ...
read full: http://finance.yahoo.com/news/flamel-technologies-announces-fda-approval-110000667.html
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##### chart ~ source: stockcharts.com
##### company info ~ source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/FLML/company-info
Ticker: $FLML
OTC Market Place: Not Available
CIK code: 0001012477
Company name: Flamel Technologies S.A.
Company website: http://www.flamel-technologies.fr
Incorporated In:
##### extra dd links
Edgar filings: http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001012477&owner=exclude&count=40
Latest filings: http://www.otcmarkets.com/stock/FLML/filings
Latest financials: http://www.otcmarkets.com/stock/FLML/financials
Latest news: http://www.otcmarkets.com/stock/FLML/news - http://finance.yahoo.com/q/h?s=FLML+Headlines
Major holdings: http://data.cnbc.com/quotes/FLML/tab/8.1
Insider transactions (1): http://finance.yahoo.com/q/it?s=FLML+Insider+Transactions
Insider transactions (2): http://www.secform4.com/insider-trading/FLML.htm
Insider transactions (3): http://www.insidercow.com/history/company.jsp?company=FLML
RegSho: http://www.regsho.com/tools/symbol_stats.php?sym=FLML&search=search
DTCC: http://search2.dtcc.com/?q=Flamel+Technologies+S.A.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information: http://www.spoke.com/search?utf8=%E2%9C%93&q=Flamel+Technologies+S.A.
Corporation WIKI: http://www.corporationwiki.com/search/results?term=Flamel+Technologies+S.A.&x=0&y=0
WHOIS: http://whois.domaintools.com/http://www.flamel-technologies.fr
Alexa: http://www.alexa.com/siteinfo/http://www.flamel-technologies.fr#
Corporate website internet archive: http://web.archive.org/web/*/http://www.flamel-technologies.fr
Short Sales: http://www.otcmarkets.com/stock/FLML/short-sales
Insider Disclosure: http://www.otcmarkets.com/stock/FLML/insider-transactions
Research Reports: http://www.otcmarkets.com/stock/FLML/research
Historical Prices: http://finance.yahoo.com/q/hp?s=FLML+Historical+Prices
Basic Tech. Analysis: http://finance.yahoo.com/q/ta?s=FLML+Basic+Tech.+Analysis
Company Profile: http://finance.yahoo.com/q/pr?s=FLML+Profile
Key Statistics: http://finance.yahoo.com/q/ks?s=FLML+Key+Statistics
Industry: http://finance.yahoo.com/q/in?s=FLML+Industry
Insider Roster: http://finance.yahoo.com/q/ir?s=FLML+Insider+Roster
Income Statement: http://finance.yahoo.com/q/is?s=FLML
Balance Sheet: http://finance.yahoo.com/q/bs?s=FLML
Cash Flow: http://finance.yahoo.com/q/cf?s=FLML+Cash+Flow&annual
Market Watch: http://www.marketwatch.com/investing/stock/FLML
Bloomberg: http://www.bloomberg.com/quote/FLML:US
Morningstar: http://quotes.morningstar.com/stock/s?t=FLML
Bussinessweek: http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=FLML
Barchart: http://www.barchart.com/quotes/stocks/FLML
OTC Short Report: http://otcshortreport.com/index.php?index=FLML
Investopedia: http://www.investopedia.com/markets/stocks/FLML/?wa=0
http://www.pennystocktweets.com/stocks/profile/FLML
##### last known share structure ~ source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: No Par Value
##### business description ~ source: otcmarkets.com
DD Notes ~ http://www.ddnotesmaker.com/FLML
fi2
Very strange. POZN gets a CRL for the same exact reason. I'm not a holder of either but I've been in bios for a little over a year and haven't seen this. Strange. The reasoning seems odd. Maybe it's just me
Hey thanks for that tip, $$eeker, good fellow there.
Here's a site for tracking FDA events.
http://www.biopharmcatalyst.com/
...first post here
(sorry if this has been discussed before)
I still have a subscription to the Agora newsletters,from a few years ago when I was stupid, its expiring soon, not sure if my stupidity is though....anyway, they have a newsletter that is starting to track the calendar dates for FDA announcements....here was the day for FLML....but I see there isn't alot of excitement about this company here.
anyway, I guess this is a company that is trying to make the dangerous and deadly side effects of pharmaceuticals a little more user friendly. That's a nice idea.
Good luck to investors and traders.
that's about all I got.
was just wanting to see what the price action looked like today. kind of a small firecracker I guess.
For what its worth...Agora does like Durata. and they are following this trading plan to watch for the pop on May 26 for DRTX.
Bought early this morning. And sold at around $12.50 also.
Too much I don't know. And I am not fond of FDA days where the price goes up on no news.
Sold what few I had at 12.50 today
I don't know...do you own a few shares?
Wondering what the details of the Submission are
Thanks for checking me.
I was thinking it was wednesday
I think 4/28 is the catalyst
I'm thinking of taking one sometime next week
I took a small position today at 11.85
Anyone interested in this stock still?
Well once we break $7 the larger institutional buyers can step in. There are only 24.5 million shares outstanding, which if the institutional buyers jump in it could really move.
If the company can back the 25+ million in sales that they think they can this one should .....
Do you think 6+ is possible?
Nothing new on the Web Site. Last Press Release was on May 23'rd?
nice close!! Just what I was lookin' for.
I bet the meeting starts at 3:30 so we will not hear anything until after close.
Do we know what time the meeting is?
PDUFA - May 31, 2013 - Conservative estimates are approximately 25 - 35 million revenue!!!
Press release from CEO from last month!!!
"First, as we mentioned on prior calls, our first NDA submission for a new hospital based product is at the FDA, and we continue to feel that we have brought our best resources in clinical and regulatory affairs to bear in the preparation of the submission. The FDA’s PDUFA target action date for our NDA is May 31, 2013.
We’re actively preparing for product launch, while we await the FDA’s action. We expect to have the product available to providers and patients as quickly as possible after an approval. If the product is approved on time, we expect the product to generate meaningful sales in 2013, and to have a positive impact on our financial results by the end of the year. The product is targeted for the hospital setting, and it could contribute from $25 million to $35 million in peak annual revenues for Flamel."
LOAD UP THE TRUCK!!!
I bet we will see some movement after likely approval on the 31st. JMO.
8:48AM Flamel Technologies Medusa-formulated interferon-alpha demonstrates favorable antiviral activity and safety in a Phase 2 clinical study (FLML) 4.09 : Co announced that its Medusa-formulated interferon-alpha ("IFN a-2b XL") was featured in a lecture and an oral presentation on June 25 at the 14th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD) held June 22-25, 2012 in Shanghai, China. The abstracts are entitled "Aggregate report on safety and efficacy of a new sustained release IFN (IFN XL) as compared to standard of care" and "Medusa formulated Interferon-alpha-2b Shows a Favorable Efficacy / Tolerability Profile vs. PEGylated IFN-alpha-2b in Hepatitis C Patients in the Phase 2 Study ANRS HC23 COAT-IFN." The abstracts presented by Professor Christian Trepo of H?pital de la Croix Rousse, Lyon, France, and Roger Kravtzoff, Preclinical and Clinical Director at Flamel Technologies, demonstrated a favorable antiviral activity and safety profile as compared with ViraferonPeg (marketed in the U.S. as PegIntron).
What was the cause of the drop?? Finacials were not great but I didn't think terible. It had such a sweet chart
curious what happens next, also on extended pipeline
ADR Report: Shares End Up As Financials Trade Higher
Flamel Technologies S.A. ADS Each Representing One Ordinary Share (MM) (NASDAQ:FLML)
http://ih.advfn.com/p.php?pid=nmona&article=51645878
Offsetting the gains of financial firms was Flamel Technologies SA (FLML), which agreed to take over specialty drug maker Eclat Pharmaceuticals in a debt-and-warrant deal and named Eclat's chief executive to replace its own CEO. Shares of Flamel tumbled 23% to $5.93.
Flamel Technologies Announces Acquisition of Eclat Pharmaceuticals Mike Anderson appointed Flamel's Chief Executive Officer; Steve Willard resigns as CEO but will remain on Board of Directors
http://www.cnbc.com/id/46739836
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