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Thu, Mar. 19, 8:23 AM
- Flamel Technologies (FLML -6.5%) Q4 results: Revenues: $3M (+200.0%); COGS: $1.4M (+999%); R&D Expense: $5.6M (+180.0%); SG&A: $4.1M (-21.2%); Operating Loss: ($33.5M) (-999%); Net Loss: ($31.9M) (-999%); Loss Per Share: ($0.81) (-910.0%).
- FY2014 results: Revenues: $14.8M (+252.4%); COGS: $3.4M (+466.7%); R&D Expense: $17.3M (+8.1%); SG&A: $15.7M (+18.9%); Operating Loss: ($93.9M) (-74.9%); Net Loss: ($88.9M) (-91.2%); Loss Per Share: ($2.46) (-34.4%); Quick Assets: $92.8M (+21.5%).
- 2015 Guidance: Product revenue: $170M - 185M.
Thu, Mar. 19, 8:07 AM| 2 Comments
Thu, Feb. 26, 12:57 PM
Fri, Jan. 16, 5:36 PM
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.
Dec. 15, 2014, 12:36 PM
- Added to the Nasdaq Biotechnology Index, effective Dec. 22: AAVL, AERI, AKBA, ALDR, ALIM, AMPH, ANIP, ASPX, CARA, CGEN, CLDN, CNCE, ENTA, FLML, FMI, FOLD, FPRX, GWPH, HPTX, ICPT, INO, INSM, KITE, KPTI, MGNX, OPHT, PCYC, PETX, POZN, PTX, QLTI, RARE, RCPT, RDUS, RLYP, RTRX, RVNC, SAGE, TBPH, TTPH, VSAR, XLRN, ZFGN, ZSPH.
- Deleted: AMRN, AUXL, CRIS, EXPR, ICEL, ONTX, RIGL, ZGNX.
- Source: Press Release
Dec. 3, 2014, 3:51 PM
- Small cap Flamel Technologies (FLML +7.7%) clears the $16 resistance level on a 3x surge in volume. Shares are up more than 50% since the October 31 low of $11.12. The company recently sold one of its manufacturing sites to a Swedish CDMO.
- Previously: Flamel sells development & manufacturing facility to Swedish firm
FLML vs. ETF Alternatives
Flamel Technologies is aspecialty pharmaceutical company. The Company is engaged indrug delivery and formulation to develop safer and more efficacious pharmaceutical products to address unmet medical needs and reduce overall healthcare costs.
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