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Xeris Biopharma Bags FDA Approval for Recorlev; Shares Pop 30%

Shares of Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) jumped almost 30% in the extended trading session on Thursday to close at $3.15 after the company announced that its cortisol synthesis inhibitor, Recorlev, received approval from the U.S. Food and Drug Administration (FDA).

Xeris Biopharma is a biopharmaceutical company that develops and commercializes unique therapies for patient populations in endocrinology, neurology, and gastroenterology.

Xeris Biopharma is scheduled to report its upcoming earnings on March 9, 2022.

Strategic Impact

Recorlev will be used for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Cushing’s syndrome is a rare but potentially fatal disease.

Notably, the approval of Recorlev is based upon safety and efficacy data from two positive Phase 3 studies that evaluated a combined study population of 166 patients, which was representative of the adult drug-treated U.S. population with Cushing’s syndrome.

Management Commentary

The CEO of Xeris Biopharma, Paul R. Edick, said, “We are thrilled with the FDA’s approval of Recorlev as a safe and effective treatment option for patients with endogenous Cushing’s syndrome. 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.”

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Analyst Ratings

Recently, Leerink Partners analyst Roanna Ruiz reiterated a Buy rating on the stock with a price target of $6, which implies upside potential of 146.9% from current levels.

Consensus among analysts is a Strong Buy based on 3 unanimous Buys. The average Xeris Biopharma price target of $5.13 implies upside potential of 111.11% from current levels. Shares have declined 50.6% over the past year. Download the mobile app now, available on iOS and Android.

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