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June 12, 2014
10:55 EDTETRMEnteroMedics may have shot for panel backing if FDA benign, TheStreet says
The FDA's review of EnteroMedics' VBLOC implantable medical device for weight loss will likely be publicly available tomorrow morning if the agency "follows historical form," according to TheStreet's Adam Feuerstein. The author believes the company "just might have a decent shot at a positive panel vote" if the review is "relatively benign," but added that if the agency "slams" VBLOC, EnteroMedics will be in "a heap of trouble" at the panel meeting next Tuesday, June 17. Reference Link
News For ETRM From The Last 14 Days
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August 28, 2014
08:55 EDTETRMOn The Fly: Pre-market Movers
HIGHER: Digital Ally (DGLY), up 16% after announcing order from Michigan State Police for over $1.1M... EnteroMedics (ETRM), up 12.4% after reporting three-year data from Maestro RC system... Repros (RPRX), up 0.8% after Androxal achieves superiority in both co-primary endpoints in a study... Synthetic Biologics (SYN), up 2.7% after Pfizer (PFE) was granted FDA Fast Track designation for its investigational Clostridium difficile vaccine candidate. Synthetic Biologics announced earlier this week that SYN-004, the company's lead anti-infective product candidate for the prevention of the effects of C. difficile, will be presented in October... Signet (SIG), up 3.9% after Q2 revenue tops consensus. DOWN AFTER EARNINGS: Abercrombie & Fitch (ANF), down 5.7%... Guess (GES), down 8.3%... Frontline (FRO), down 7%. ALSO LOWER: Williams-Sonoma (WSM), down 10.9% after downgraded at Morgan Stanley following the company's Q2 earnings report... GT Advanced (GTAT), down 2% after downgraded at Raymond James... Sungy Mobile (GOMO), down 20.1% following earnings report, CFO resignation, downgrade of stock at Oppenheimer... Genesco (GCO), down 7.7% after cutting fiscal year forecast.
07:09 EDTETRMEnteroMedics reports three-year data from Maestro RC system
EnteroMedics announced that three year diabetes, hypertension and weight loss data from the company's DM2 ENABLE Study of VBLOC vagal blocking therapy delivered via the Maestro Rechargeable System continue to demonstrate both medically meaningful weight loss as well as improvement in diabetes control in obese subjects with Type II Diabetes Mellitus. The DM2 Study is designed to evaluate the safety and efficacy of VBLOC vagal blocking therapy delivered via the Maestro RC System in 28 diabetic subjects with obesity by measuring average percentage excess weight loss, blood sugar, fasting plasma glucose and blood pressure, following device activation. To date, no unanticipated adverse device effects have been reported and the safety profile is similar to that seen in other VBLOC clinical trials. These metabolic effects in diabetes, hypertension and weight loss are consistent with previous findings from other time points and are considered medically meaningful improvements.

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