Xeris Biopharma outlined XP-8121’s development plan, including a potential peak net Revenue range of $1 billion to $3 billion. For investors, the program offers a defined timeline from a Phase 3 start expected by year-end 2026 to anticipated approval and launch in 2030, subject to clinical and regulatory outcomes.

Key Highlights

  • Xeris hosted an XP-8121 program webinar on September 9, 2026.
  • The company identified 3-5 million U.S. hypothyroidism patients as failing existing treatments.
  • Cornerstone is expected to begin by year-end 2026, with topline results anticipated in late 2028.

The once-weekly subcutaneous levothyroxine candidate is being developed for hypothyroidism, with anticipated approval and commercial launch in 2030.

XP-8121 Development Plan Advances

The program overview hosted on September 9 featured presentations from Chief Executive Officer John Shannon, Chief Medical Officer Anh Nguyen and other named speakers, including endocrinologist David Robertson, MD. The presentation described XP-8121 as a weekly injection designed to bypass the gastrointestinal tract and address limitations associated with oral absorption. Cornerstone is expected to start by year-end 2026, while Touchstone is expected to begin in 2027. The presentation identified 3-5 million U.S. patients treated for hypothyroidism as failing on existing treatments. It also described a target of approximately $750M in total revenue from the existing commercial portfolio in 2030. Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) said its commercial infrastructure is already built and proven, while the candidate remains subject to clinical development and regulatory approval.