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Xeris Biopharma Holdings, Inc. reports news about its commercial biopharmaceutical business, including product revenue, financial guidance and operating updates tied to Recorlev®, Gvoke® and Keveyis®. The company commercializes Recorlev for endogenous Cushing’s syndrome, Gvoke ready-to-use liquid glucagon for severe hypoglycemia and Keveyis for primary periodic paralysis.
Recurring updates also cover development of XP-8121, a Phase 3-ready once-weekly subcutaneous levothyroxine candidate for hypothyroidism, and programs using Xeris’ XeriSol® and XeriJect® technology platforms. Company news includes intellectual property developments for Recorlev, partnership-related revenue, and equity inducement grants under Nasdaq listing rules.
Xeris Biopharma (XERS) will host an XP-8121 Program Overview webinar today, September 9, at 10 a.m. ET to present its development and commercialization plans for XP-8121, an investigational once-weekly subcutaneous levothyroxine for hypothyroidism. The company plans to initiate Cornerstone, a Phase 3 registrational trial, by year-end, with topline results expected in late 2028 and, if successful, U.S. FDA approval and launch anticipated in 2030. Xeris expects XP-8121 to have peak net revenue potential of $1 to $3 billion.
The Cornerstone trial will randomize about 500 adults and adolescents with well-controlled hypothyroidism 1:1 to XP-8121 or daily oral levothyroxine for 54 weeks across more than 50 U.S. sites. The primary endpoint is the proportion of subjects with thyroid-stimulating hormone in the normal range at both weeks 48 and 54, with a 15% non-inferiority margin and more than 90% power. Additional studies include Capstone in pediatric patients, Touchstone in difficult-to-control patients, and real-world evidence analyses.
Xeris Biopharma (Nasdaq:XERS) announced a Program Overview webinar for XP-8121, its Phase 3-ready, once-weekly subcutaneous levothyroxine injection for hypothyroidism. The event will be held on Wednesday, September 9, 2026, at 10 a.m. ET and will feature a leading endocrinologist and Xeris program leaders.
Topics include unmet medical needs in hypothyroidism, XP-8121’s market opportunity, and plans for the Phase 3 registrational program, covering trial design, endpoints, target patient population, development milestones, and anticipated regulatory timelines. A replay will be available after the live presentation, and advance registration is encouraged.
Xeris Biopharma (Nasdaq: XERS) reported second quarter 2026 total revenue of $92.1 million, up 29% year-over-year, with net product revenue of $91.0 million, up 34%. Recorlev revenue rose 81% to $56.8 million, while Gvoke declined 4% to $22.5 million and Keveyis grew 2% to $11.7 million. Gross margin improved to 86% from 82%.
The company recorded a net loss of $31.1 million, versus a $1.9 million loss a year ago, mainly due to an approximately $31 million one-time, non-cash charge tied to 2028 Convertible Notes exchange agreements. Adjusted EBITDA was $19.3 million in Q2 and $34.4 million year-to-date. Xeris tightened full-year 2026 total revenue guidance to $385–$390 million, eliminated all outstanding 2028 Convertible Notes through exchanges and conversions, and highlighted new U.S. patent protection expected for Keveyis through at least 2039 plus an additional patent for XP-8121.
Xeris Biopharma (Nasdaq: XERS) will release its second quarter 2026 financial results before U.S. markets open on Thursday, August 6, 2026. Management will hold a conference call and webcast at 8:30 a.m. Eastern Time the same day to review financial and operational results.
Investors can pre-register for the call via the Events section of Xeris’ investor relations website, where the live webcast, replay, and related materials will be available. Xeris develops and commercializes therapies including Recorlev, Gvoke, and Keveyis, and is advancing XP-8121 and other pipeline programs.
Xeris (Nasdaq:XERS) reported that on July 1, 2026, its Board Compensation Committee granted 221,323 restricted stock units to 47 new employees under the company’s Inducement Equity Plan, in line with Nasdaq Rule 5635(c)(4).
The RSUs vest in three equal annual installments, subject to continued employment and the plan’s award agreements.
Summary not available.
Xeris Biopharma (Nasdaq:XERS) announced key Board changes effective July 1, 2026. CEO John Shannon will also become Chair of the Board, succeeding Marla Persky, who transitions to Lead Independent Director. The Board appointed Nerissa Kreher, M.D., expanding membership to eight directors.
Xeris Biopharma (Nasdaq:XERS) announced a U.S. Patent and Trademark Office Notice of Allowance for U.S. Patent Application No. 17/151,405 covering the use of KEVEYIS (dichlorphenamide).
The patent is expected to protect KEVEYIS in the U.S. through 2039, with Orange Book listing planned after issuance.
Xeris Biopharma (Nasdaq:XERS) entered privately negotiated exchange agreements to retire approximately $23 million of its 8.00% Convertible Senior Notes due 2028. This is expected to reduce annual interest expense by about $2 million.
Consideration totals about $23 million in cash plus common stock based on a 21‑day VWAP starting June 11, 2026. Assuming a $6.71 share price, Xeris expects to issue roughly 4.6 million shares. After closing, $10.5 million principal of the Notes will remain outstanding.
Xeris (NASDAQ: XERS) reported strong Q1 2026 results: total product revenue rose 43% to $82.45 million and Recorlev net revenue nearly doubled to $49.8 million (≈95% growth). Total revenue was $83.13 million. Gross margin improved to 87%. Net income was $2.2 million; Adjusted EBITDA was $15.1 million. Management tightened 2026 total revenue guidance to $380–$390 million and highlighted planned Phase 3 initiation for XP-8121 later in 2026. Shares outstanding were 172,642,055 at April 30, 2026.