Ironwood Pharmaceuticals

At the Wells Fargo conference, Ironwood highlighted that a realignment of the LINZESS pricing strategy increased net revenues by $300–350 million and lifts the annual LINZESS guidance to over $1 billion. The company paid off a $200 million convertible note, reduced leverage to under 1.0x EBITDA, and says it is well-positioned financially to continue developing Apraglutid. The FDA is requiring a confirmatory study after an identified dosing issue for Apraglutid; Ironwood is targeting an NDA filing in 2029 and emphasizes the large, underexploited market potential in SBS-IF. » Mere på de.investing.com

Ironwood reiterated guidance for fiscal 2026 adjusted EBITDA of at least $300 million, citing eased LINZESS headwinds, higher U.S. LINZESS sales and disciplined expense control to support cash flow and debt reduction. Citizens analyst Jason Butler maintained an Outperform rating and raised the price target from $8 to $10 after fourth-quarter results met guidance and the company reaffirmed its 2026 outlook. Ironwood is prioritizing maximizing LINZESS revenue while advancing apraglutide, with initiation of STARS-2 confirmatory Phase 3 sites expected in Q2. » Mere på finance.yahoo.com

Ironwood Pharmaceuticals forecasts 2026 U.S. net sales for LINZESS of more than $1.1 billion and is targeting adjusted EBITDA of over $300 million. A confirmatory Phase III study for Apraglutid (STARS-2) is planned to start in the second quarter; a regulatory submission is scheduled for late 2029. The company aims to repay $200 million in convertible notes by June and reduce total debt to around $300 million by year-end. Strategically, the focus is on using LINZESS cash flows to fund Apraglutid development, pay down debt and pursue potential partnerships outside the U.S. » Mere på de.investing.com

Ironwood reported a Q4 loss of $0.01 per share and revenue of $47.7 million, missing expectations; management attributes this mainly to timing-related accruals for rebate reserves. For full-year 2025 the company posted solid figures with $296 million in revenue, $24 million in net income and strong operating cash flow; LINZESS generated $865 million in US net revenue. Ironwood expects LINZESS US net revenue of $1.125–1.175 billion in 2026 (>30% growth), plans to reduce debt to around $300 million and targets adjusted EBITDA of over $300 million. The company is also advancing phase 3 planning for Apraglutid and sees additional upside from pediatric approval and pricing strategy, but investors remain cautious due to the quarterly miss and execution risks. » Mere på de.investing.com

Shares of Ironwood Pharmaceuticals climbed about 8% after the FDA approved the capsule version of Linzess (active ingredient linaclotide) for pediatric patients aged 7 and older with irritable bowel syndrome with constipation. Linzess is thus the first treatment approved for IBS‑C in children; the decision was based on extrapolated adult data and a 12‑week study in 7‑ to 17‑year‑olds. The recommended dose is 145 mcg once daily, the safety profile matched that seen in adults, and diarrhea was the most common side effect; use is contraindicated in children under 2 years due to the risk of dehydration. » Mere på de.investing.com