Xeris Biopharma Holdings Inc (NASDAQ:$Xeris Pharmaceuticals(XERS.US)$) is trading higher Friday morning after the company announced U.S. Food and Drug Administration approval of Recorlev for the treatment of endogenous hypercortisolemia in adult patients with Cushing's Syndrome.
The approval of Recorlev was based upon safety and efficacy data from two positive Phase 3 studies.
The study titled "SONICS" met its primary and key secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase.
The study titled "LOGICS" also met its primary and key secondary endpoints, confirming the efficacy and safety of Recorlev in normalizing and maintaining therapeutic response compared with the placebo.
"With this approval, Xeris' experienced endocrinology-focused commercial organization can begin rapidly working to help address the needs of Cushing's syndrome patients in the U.S. who are treated with prescription therapy," said Paul Edick, chairman and CEO of Xeris Biopharma.
HC Wainwright & Co. analyst Oren Livnat maintained Xeris Biopharma with a Buy rating and raised the price target from $4.25 to $5.40.
SVB Leerink analyst Roanna Ruiz maintained Xeris Biopharma with an Outperform rating and raised the price target from $6 to $8.
Xeris Biopharma is a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology.
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XERS Price Action: Xeris has traded as low as $1.77 and as high as $7.94 over a 52-week period.
The stock was up 24.30% at $3.02 at time of publication.