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SENS

Senseonics

$3.00

0.21 (7.53%)

07:55
03/30/18
03/30
07:55
03/30/18
07:55

FDA Clinical Chemistry and Clinical Toxicology Devices Panel holds meeting

The Committee discusses, makes recommendations and votes on information regarding a premarket approval application to market a novel continuous glucose monitoring device system, the Senseonics, Inc., Eversense CGM System, which requires minor surgery to implant and remove and, if approved, would provide 90 days of sensor glucose values from each implanted sensor. The meeting will be held in Gaithersburg, MD on March 29-30 at 8 am. Webcast Link

SENS Senseonics
$3.00

0.21 (7.53%)

03/28/18
LEER
03/28/18
NO CHANGE
LEER
Outperform
Senseonics Eversense CGM briefing docs 'largely benign,' says Leerink
Leerink analyst Danielle Antalffy notes that the FDA has released the briefing documents for the upcoming panel meeting to review Senseonics' Eversense Continuous Glucose Monitoring to secure a PMA approval. The analyst views the panel docs as "largely benign" and support her view that with a best-in-class 8.5% Mean Absolute Relative Difference with the algorithm improvement, the panel should largely vote in Senseonics' favor on both safety and effectiveness. Antalffy reiterates an Outperform rating on the shares.
06/06/17
LEER
06/06/17
NO CHANGE
Target $6
LEER
Outperform
Senseonics share offering removes overhang, says Leerink
Leerink analyst Danielle Antalffy views Senseonics' recent $41M share offering as a "financially sound move" that removes an overhang. The company's balance sheet is now shored up ahead of the U.S. launch, Antalffy tells investors in a research note. Senseonics' cash position should be sufficient to fund its operations at least through mid-2018, the analyst adds. She views the current valuation levels as an attractive entry point and reiterates an Outperform rating on the shares with a $6 price target.

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