Xeris Biopharma Holdings, Inc. 8K

Xeris Biopharma is detailing the clinical and commercial plan for XP-8121, a once-weekly subcutaneous levothyroxine, including a Phase 3 program targeting potential FDA approval and a 2030 U.S. launch with $1–3 billion peak revenue potential.

Xeris Biopharma Holdings, Inc. announced that it is hosting a webinar to present a comprehensive development program for XP-8121, its investigational once-weekly subcutaneous levothyroxine for hypothyroidism, outlining the design and objectives of the Cornerstone Phase 3 registrational trial, related Capstone pediatric and Touchstone special-population studies, real-world evidence plans, and its expectations for trial initiation by year-end 2026, topline data in late 2028, potential U.S. FDA approval and commercial launch in 2030, and an estimated peak net revenue opportunity of $1–3 billion.

Filing Facts

CIK

1867096

Ticker

XERS

Form

8K

Source Type

fda

Accession

0001867096-26-000077

Alert Tier

6