Ironwood Raises 2026 Guidance on LINZESS Growth

Ironwood Pharmaceuticals (Nasdaq: IRWD) raised its full-year 2026 financial guidance after LINZESS U.S. net sales increased 3% year over year to $325 million in the third quarter, supported by 5% prescription demand growth that offset a low-single-digit net price decline. The company also reported $60 million in GAAP net income and record adjusted EBITDA of $98 million for the quarter.

Ironwood now expects 2026 LINZESS U.S. net sales of $1.20 billion to $1.25 billion, up from its August guidance of $1.15 billion to $1.20 billion. The revised range represents growth of more than 35% from 2025. Total revenue guidance increased to $485 million to $510 million from $460 million to $485 million, while adjusted EBITDA is now expected to exceed $350 million, compared with the previous forecast of more than $310 million.

LINZESS sales surpass 2025 total

LINZESS U.S. net sales reported by Ironwood’s partner AbbVie reached $879.8 million for the first nine months of 2026, exceeding the product’s $865 million in net sales for all of 2025. Year-to-date net sales grew 25%, reflecting improved net pricing and 5% growth in total prescription extended units.

Ironwood attributed the year-to-date pricing improvement to the elimination of inflationary rebates and favorable timing of gross-to-net rebate reserves compared with 2025. In the third quarter alone, however, unfavorable reserve timing contributed to a low-single-digit net price decline from the prior-year period.

Ironwood collaborates with AbbVie on LINZESS in North America and receives 50% of the net profits, while bearing 50% of the net losses, from U.S. commercial sales. The collaboration generated total net profit of $255.9 million in the third quarter, with an 80% commercial margin. Ironwood’s share of net profit was $129.6 million, and its LINZESS collaborative arrangements revenue totaled $129.9 million.

Total Ironwood revenue was $133 million, primarily reflecting the LINZESS collaboration. GAAP net income was $59.8 million, or $0.36 per basic and diluted share. Adjusted EBITDA, a non-GAAP measure, was $97.9 million. For the first nine months, GAAP net income totaled $151.9 million and adjusted EBITDA was $257.6 million.

Apraglutide trial expands globally

Ironwood is also expanding the confirmatory Phase 3 STARS-2 trial of apraglutide, its once-weekly GLP-2 analog candidate for adults with short bowel syndrome with intestinal failure who depend on parenteral support. The trial is actively recruiting, and the company said planned U.S. and international site expansion remains on track.

Clinical trial applications have been submitted across the program’s targeted markets, with international health authorities reviewing the filings. Ironwood plans to activate more than 100 sites across 22 countries in the Americas, Europe and Asia-Pacific, including twice as many U.S. sites as in the earlier STARS program.

The company intends to use data from STARS, the long-term STARS-Extend study and STARS-2 to support a comprehensive new drug application. Ironwood said the earlier Phase 3 STARS trial showed a reduction in parenteral-support volume that was twice that of placebo at 24 weeks, while extension-study data indicated improvement was sustained over time. The company’s stated goal is for apraglutide to become the first long-acting GLP-2 analog introduced in the U.S., although regulatory approval is not assured.

Ironwood also announced that Chief Commercial Officer Tammi Gaskins has been appointed chief executive officer as part of a planned leadership transition.

The company identified clinical recruitment, trial execution, safety and tolerability, manufacturing, regulatory review, pricing and reimbursement, competition and intellectual-property protection among the principal uncertainties facing its plans. It also cautioned that apraglutide’s development may not proceed as expected or result in regulatory approval, while LINZESS performance remains exposed to reimbursement policies, competitive products and the accounting and settlement practices governing its collaboration with AbbVie.