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Ironwood Receives FDA Approval for Linzess in Children Aged 2 and Older
Ironwood Pharmaceuticals announced that the U.S. Food and Drug Administration has approved the use of Linzess in pediatric patients 2 years of age and older with functional constipation. "Linzess was previously approved for pediatric patients 6 years and older with FC. With this expanded indication, Linzess is now available for children ages 2-5 years with FC and remains the only FDA-approved prescription therapy for pediatric FC," the company stated.
Kyverna Therapeutics Appoints Greg Martini as CFO
Kyverna Therapeutics (KYTX) announced the appointment of Greg Martini as CFO, effective May 18. Martini succeeds Marc Grasso who will be consulting for the company to ensure a transition. With this appointment, Martini will lead Kyverna's financial strategy and operations, including corporate finance, capital allocation, and investor relations. Martini joins Kyverna from Ironwood (IRWD) where he most recently served as senior VP and CFO.
Affirms 2026 Adjusted EBITDA View of Over $300M
Affirms 2026 adjusted EBITDA view of over $300M.
Ironwood Reports Q1 Revenue of $106.5M, Beating Consensus
Reports Q1 revenue $106.5M, consensus $92.1M. "Our first quarter of 2026 delivered strong financial performance, driven by significantly improved net price and mid-single digit prescription growth for LINZESS, positioning us well to achieve our full-year 2026 financial guidance," said Tom McCourt, chief executive officer of Ironwood. "We expect strong first quarter revenue to result in significant operating cash flows in the second quarter of 2026, which will help support repayment of our 2026 convertible notes at maturity in June." "We remain on track for site initiation for the confirmatory STARS-2 Phase 3 clinical trial in the second quarter," said Michael Shetzline, chief medical officer, senior vice president and head of research and drug development at Ironwood. "Building on the positive results from STARS, we believe that the highly potent, selective, and long-acting pharmacologic properties of apraglutide have the potential to drive best-in-class efficacy and tolerability with once-weekly dosing and redefine the standard of care in SBS-IF. Importantly, the long-term data generated to date show compelling enteral autonomy outcomes, with rapid and sustained reductions in parenteral support over time."
Company Expects FY26 Adjusted EBITDA of At Least $300M
Sees FY26 adjusted EBITDA at least $300M. The company said, "As we enter 2026, we remain focused on our core priorities of maximizing LINZESS, advancing apraglutide and delivering sustained profits and cash flows. We believe our full-year 2026 financial guidance demonstrates the significant progress we've made across these priorities and our ability to drive increasing shareholder value. In 2026, we expect increased LINZESS U.S. Net Sales and disciplined expense management to drive greater than $300 million in adjusted EBITDA, enabling us to continue advancing apraglutide and reduce our debt to further strengthen our financial position. We believe apraglutide has the potential to redefine the standard of care for patients living with SBS-IF and look forward to initiating sites for the confirmatory Phase 3 clinical trial, STARS-2, in the second quarter of this year. With an improved financial position, we now have a clear path to execute our strategy, and we continue to evaluate all options to maximize shareholder value."
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