Xeris Biopharma Holdings, Inc. filed a Current Report on Form 8-K on September 9, 2026, announcing an investor presentation regarding its XP-8121 program. The filing details the company's comprehensive clinical development plan for the drug candidate, which is designed to treat hypothyroidism.
According to the presentation, XP-8121 is a once-weekly subcutaneous levothyroxine therapy intended to bypass the limitations of oral absorption. The company projects a potential peak net revenue of $1 billion to $3 billion based on a target population of 3 to 5 million patients in the United States.
The development strategy includes three key studies:
- Cornerstone: A Phase 3 study expected to initiate by year-end 2026. The study will enroll 500 participants across more than 50 U.S. sites to demonstrate equivalence to daily oral levothyroxine. Data is expected in late 2028.
- Capstone: A study evaluating dose conversion in pediatric patients.
- Touchstone: A study designed to evaluate efficacy in patients with inconsistent control or inadequately treated hypothyroidism.
The company stated that XP-8121 is being developed entirely self-funded. Management anticipates seeking regulatory approval and commercial launch in 2030.
