Ironwood Sees LINZESS Above $1.1 Billion in 2026 as FDA-Aligned STARS II Nears Launch

Overview

• Ironwood guided to more than $1.1 billion in 2026 U.S. LINZESS net sales and greater than $300 million in adjusted EBITDA, citing improved net price and low single-digit demand growth.
• LINZESS delivered $865 million in 2025 U.S. net sales with 11% prescription demand growth and 8% new-to-brand growth, and gained FDA approval in November 2025 for IBS‑C in patients aged 7 and older.
• The LINZESS list price was reduced effective January 1, 2026 to support patient access, with management flagging a projected increase of more than 30% in Medicaid-related headwinds this year due to policy changes.
• Ironwood reported FDA alignment on the confirmatory Phase III STARS II trial for aproglutide, plans site activation in Q2 2026, and attributed the new study to lower-than-planned exposure in the original trial tied to administration and kit issues; the design adds refined instructions and improved components.
• The company ended 2025 with cash and equivalents reported at $250 million on the earnings call, though a separate summary cited $215 million, and management plans to use cash generation to advance R&D and reduce debt.