Xeris Biopharma Holdings Stock Price, News & Analysis

Xeris Biopharma Holdings (Nasdaq: XERS) announced that CEO Paul R. Edick will present at the 41st Annual J.P. Morgan Healthcare Conference on January 12, 2023, at 12:00 PM PT. Interested parties can access the presentation on the company's investor relations page. Xeris focuses on developing innovative biopharmaceutical products, including Gvoke®, Keveyis®, and Recorlev®. The company also leverages advanced formulation technology platforms, XeriSol™ and XeriJect™, to enhance therapeutic options for patients.

Xeris Biopharma Holdings (Nasdaq: XERS) expects to conclude 2022 with over $120 million in cash and achieve net product revenue at the upper end of its guidance, between $105 million and $110 million. The company experienced strong demand for its products, notably Recorlev and Keveyis, and positive prescription growth for Gvoke. It drew down the final $50 million from its debt facility and secured an upfront payment from a collaboration with Horizon Therapeutics.

Xeris Biopharma Holdings (Nasdaq: XERS) announced plans to initiate a Phase II study in the second half of 2023 for a novel formulation of levothyroxine sodium (SC injection) as replacement therapy for hypothyroidism. This decision follows positive feedback from an FDA Type C meeting regarding the clinical plan for a once-weekly subcutaneous formulation. The Phase II study aims to assess the average dosing and chronic safety data. The company had previously reported positive Phase I data, indicating safety and effective absorption profiles compared to current treatments.

Xeris Biopharma Holdings (XERS) has partnered with Horizon Therapeutics (HZNP) to develop an ultra-concentrated, ready-to-use subcutaneous injection of teprotumumab, FDA-approved for Thyroid Eye Disease. The agreement utilizes Xeris' proprietary XeriJect technology, enhancing patient treatment experience. Xeris will receive an upfront payment and may earn additional milestone payments and royalties if the technology is licensed. This collaboration aims to improve drug delivery and patient adherence. No specific financial terms were disclosed.

Xeris Biopharma achieved record net product revenue of $29.6 million in Q3 2022, a 17% increase from Q2 2022 and a 31% increase year-over-year on a pro forma basis. The company tightened its full-year revenue guidance to $105M-$110M and raised year-end cash balance guidance to $110M-$120M. Notable revenue drivers included Gvoke with $13.7 million and Keveyis with $13.4 million. The firm reported positive results from its Phase 1 study of XP-8121 and published findings on Recorlev in the European Journal of Endocrinology.

Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) announced the release of its third quarter 2022 financial results on November 9, 2022, before U.S. market open. The company will host a conference call at 8:30 a.m. ET on the same day to discuss financial and operational outcomes. Xeris focuses on innovative biopharmaceutical products, including Gvoke® for severe hypoglycemia, Keveyis® for primary periodic paralysis, and Recorlev® for Cushing’s syndrome. The company aims to extend current products to new indications and develop new therapies through proprietary formulation technologies.

Xeris Biopharma Holdings (NASDAQ: XERS) announced positive results from the extended evaluation of its SONICS study, evaluating levoketoconazole for treating Cushing's syndrome. The study showed sustained cortisol level reductions and quality of life improvements over a median treatment duration of 15 months. Notably, 46 patients completed the study with only a 6.7% discontinuation rate due to adverse events. Levoketoconazole demonstrated safety with no new drug-related signals. The treatment continues to support its role in managing this rare but serious endocrine disease.

Xeris Biopharma Holdings (XERS) announced positive topline results from its Phase 1 study of XP-8121, a novel subcutaneous levothyroxine formulation. This study, involving 60 healthy adults, showed that XP-8121 provides similar pharmacokinetics to daily oral Synthroid, offering a potential once-weekly dosing option. The data suggests that a 1200 μg SC dose of XP-8121 could correspond to a 300 μg dose of Synthroid, indicating a 4X dose conversion factor. The treatment was well tolerated, and the company expects FDA feedback by year-end.

Xeris Biopharma achieved record net product revenue of $25.3 million for Q2 2022, reflecting a 15% increase from Q1 2022 and a 34% increase year-over-year on a pro forma basis. The company ended Q2 with $111.6 million in cash and investments, reaffirming a full-year revenue guidance of $105 million to $120 million. Key products such as Gvoke and Keveyis reported strong performances, with Gvoke growing by 30% to $11.5 million in revenue. However, net losses were reported at $26.2 million for the quarter.