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Flamel Technologies S.A. (FLML)

  • Thu, Feb. 26, 12:57 PM
  • Fri, Jan. 16, 5:36 PM
    | 1 Comment
  • Wed, Jan. 14, 1:46 PM
    • In a letter to shareholders, Flamel Technologies (FLML -47.5%) says that it is "in discussions" with regulatory and legal counsel to devise a plan to minimize the encroachment of a new competitor to its lead product Bloxiverz.
    • The FDA just approved Fresenius Kabi's New Drug Application (NDA) for its version of neostigmine methylsulfate.
  • Wed, Jan. 14, 12:43 PM
  • Wed, Jan. 14, 11:51 AM
    • Flamel Technologies (FLML -25%) drops on a 6x surge in volume in apparent response a favorable ruling from the USPTO for Jazz Pharmaceuticals (JAZZ +3.1%) and against the petitions from Par Pharmaceuticals, Roxane Labs and Amneal Pharmaceuticals. The decision reaffirmed the validity of four patents related to Xyrem (#'s 7,895,059, 8,457,988, 7,668,730, 8,589,182).
    • In October, Canaccord Genuity analyst John Newman published a research report reiterating his Buy recommendation on Jazz Pharmaceuticals (JAZZ +3.8%) with a $163 price target based on his view that Flamel's NDA for its once-daily version of Xyrem (sodium oxybate), to be filed under the 505(NYSE:B)(2) paragraph IV pathway, will reference Jazz's orange book-listed patents. This will trigger a lawsuit and and an automatic 30-month stay of approval.
    • The delay will give Jazz more time to develop its once-daily version, JZP-386, which should enter Phase 2 this year.
  • Dec. 19, 2014, 1:13 PM
    • Thinly-traded small cap Flamel Technologies (FLML +12%) heads north in response to its announcement that it achieved its objective of a single before-bedtime dose of sodium oxybate using its proprietary Micropump technology. A single dose option for sufferers of narcolepsy would eliminate a second dose 2.5 to 4 hours later that is necessary with the current standard of care, Jazz Pharmaceuticals' (JAZZ -0.9%) Xyrem (sodium oxybate). This would be more convenient and would eliminate the disruption in sleep.
    • Flamel plans to meet with the FDA before mid-2015 to clarify a regulatory path.
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  • Dec. 3, 2014, 3:51 PM
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  • Nov. 13, 2014, 12:48 PM
  • Jun. 20, 2014, 1:16 PM
    • Shares of Flamel Technologies (FLML +15.7%) pop on a 5x surge in volume representing a tidy 450% gain from the December 2012 low of $2.85. The fuel for the uptrend is the expectation that the FDA will issue a ruling that will favor Flamel's Bloxiverz (neostigmine methysulfate injection).
    • Neostigmine was first synthesized in 1931, making it eligible for grandfathering when the FDA was established. No company had an approved NDA for the product until Flamel's in July 2013. The regulator typically removes unapproved products within one year after it clears an NDA. Bloxiverz will enjoy a period of exclusivity as a result. Approximately 5M vials of neostigmine are sold in the U.S. each year.
  • Jun. 20, 2014, 12:45 PM
    | 1 Comment
  • Apr. 29, 2014, 12:46 PM
    | 1 Comment
  • Sep. 11, 2013, 11:03 AM
    • Shares of Flamel Technologies (FLML +3.1%) pop after the FDA accepts the company's second NDA.
    • A PDUFA date is set for April 28, 2014.
    • Further analysis here is impeded by the following: "For competitive reasons, the company has decided not to identify the product at this time." (PR)
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  • Jun. 6, 2013, 2:01 PM
    Flamel Technologies (FLML +1.5%) bucks a weak tape today after saying it's signed a multi-year development partnership agreement with an undisclosed, large international pharmaceutical company. The development work, which will be done in Flamel's Bordeaux facility in France, is expected to generate revenue of over $4M over the next several years, and could be expanded.
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  • Mar. 22, 2013, 11:49 AM
    Flamel Technologies (FLML +3.2%) says that a U.S. District Court has dismissed a class action suit against the company, and its former CEO. The initial class action, filed in 2007, alleged that the company made false claims about Coreg CR, a medication commonly used to treat conditions related to the heart and blood vessels. In dismissing the case, the judge stated that there was no substantive fact, and no reasonable jury could possibly find in the lead plaintiff's favor.
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  • Feb. 26, 2013, 12:45 PM
    Midday top 10 gainers: MNOV +54%. RNIN +45%. CWH +31%. SLCA +22%. ALC +22%. NOAH +16%. GMXR +14%. PRPH +13%. EMITF +13%. FLML +12%.
    Midday top 10 losers: FSGI -25%. HSII -20%. VRTB -19%. VSI -18%. TWI -16%. SSP -13%. ENMD -12%. VVUS -12%. VIPS -10%. CHMT -10%.
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  • Jan. 11, 2013, 12:45 PM
    Midday top 10 gainers: UPIP +31%. KGJI +20%. INFY +17%. DNDN +15%. REDF +14%. FLML +14%. BBY +12%. SIFY +11%. ICAD +10%. BCRX +10%.
    Midday top 10 Losers: NEWL -29%. ARQL -15%. YOD -15%. PDEX -12%. BV -11%. RGLS -10%. FARO -9%. CENX -9%. MY -9%. STXS -9%.
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Company Description
Flamel Technologies is a biopharmaceutical company mainly engaged in the development of two unique polymer-based drug delivery technologies for the improvement of medical applications.
Sector: Healthcare
Country: France