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Thursday, August 20, 2020

FDA warns Xeris over Gvoke ad; shares down

Xeris Pharmaceuticals (XERS -13.3%) is down on more than double normal volume in apparent reaction to its receipt of an FDA Warning Letter concerning its promotion of Gvoke (glucagon), approved in the U.S. a year ago for the treatment of severe low blood sugar in diabetics at least two years old.

The agency states that its television advertisement makes “false and misleading” claims and representations about the risks associated with the product, which constitutes misbranding, requesting that it immediately stop violating federal law.

The company has until Friday, August 28, to submit its written response to the letter.


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