Xeris Biopharma leaps, as FDA approves Recorlev

US specialty pharma company Xeris Biopharma (Nasdaq: XERS) saw its share leap nearly 30% to $3.15 post-market on Thursday, after it announced that the US Food and Drug Administration had approved its Recorlev (levoketoconazole) 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.

“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 US who are treated with prescription therapy,” said Paul Edick, chairman and chief executive of Xeris Biopharma. “Today’s announcement also reinforces the value that we saw in acquiring Strongbridge Biopharma’s attractive rare disease portfolio, which we believe will deliver compelling long-term value to our shareholders. We look forward to making Recorlev commercially available in the first quarter,” he added.

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