Biopharma · FDA Approvals · Stock
Xeris Biopharma Holdings Inc is a commercial-stage biopharmaceutical company focused on developing and commercializing therapies for people with chronic endocrine and neurological diseases in the United States. It offers Recorlev for the treatment of endogenous hypercortisolemia in patients with Cushing's syndrome; Gvo…
Assets on file: levoketoconazole, XP-8121
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Xeris (XERS) to present Recorlev, Gvoke and XP-8121 data at 2026 CRC, CMHC and ATA meetings
Xeris will present new real-world data on Recorlev (levoketoconazole) for Cushing’s syndrome at the Cardiometabolic Health Congress on October 15-16 2026, including a case study on cortisol normalization and cardiometabolic improvements. Additional presentations cover Gvoke for severe hypoglycemia and a TriNetX analysis on levothyroxine/TSH in hypothyroidism.
Xeris initiates Phase 3 Cornerstone trial for XP-8121 in hypothyroidism
Xeris disclosed that the Cornerstone Phase 3 study of once-weekly subcutaneous XP-8121 is expected to begin by year-end 2026, fully aligned with prior FDA feedback on endpoints and statistical power. The trial will enroll 500 well-controlled adults and adolescents across >50 U.S. sites, with topline data anticipated in late 2028 and potential NDA filing and launch targeted for 2030.
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