Welcome to our dedicated page for Ironwood news (Ticker: IRWD), a resource for investors and traders seeking the latest updates and insights on Ironwood stock.
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) is a biotechnology company focused on gastrointestinal (GI) and rare diseases, and its news flow reflects this specialization. Investors and followers of IRWD news will see regular updates on the performance and clinical development of its key assets, particularly LINZESS® (linaclotide) and apraglutide.
News about LINZESS often covers U.S. net sales, prescription demand trends based on IQVIA data, and changes in financial guidance related to collaboration revenue and adjusted EBITDA. Ironwood and its U.S. partner AbbVie share equally in U.S. brand collaboration profits, so quarterly and full-year results frequently highlight LINZESS commercial margin, net profit for the U.S. brand collaboration, and the impact of pricing dynamics, gross-to-net rebate reserves and healthcare policy changes.
For apraglutide, Ironwood’s news includes clinical and regulatory milestones in short bowel syndrome with intestinal failure (SBS-IF). Press releases describe data from the STARS Phase 3 trial and the STARS Extend long-term extension study, including the number of apraglutide-dosed patients achieving enteral autonomy, as well as feedback from the U.S. Food and Drug Administration on the need for a confirmatory Phase 3 trial. Updates on the timing and design of this confirmatory trial and on regulatory submissions are recurring themes.
IRWD news also covers financial guidance for LINZESS U.S. net sales, total revenue and adjusted EBITDA, along with restructuring activities, cost management efforts and strategic reorganization steps. Additional announcements address topics such as Nasdaq listing notifications, changes in the company’s independent registered public accounting firm, participation in investor and scientific conferences, and the ongoing review of strategic alternatives with financial advisors.
By following this IRWD news page, readers can track how Ironwood’s GI and rare disease programs progress over time, how financial expectations evolve, and how regulatory, commercial and strategic developments may influence the company’s outlook.
Ironwood Pharmaceuticals (NASDAQ: IRWD) announced FDA approval for a revised label of LINZESS (linaclotide) based on pediatric clinical safety data. The update narrows the boxed warning for dehydration risks to children under two years, previously applicable to all under 18. The labeling reflects ongoing studies to enhance safety profiles for pediatric use. LINZESS remains contraindicated for children under two, and its effectiveness for patients under 18 is not yet established. The drug is indicated for adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
Ironwood Pharmaceuticals (Nasdaq: IRWD) reported robust Q2 2021 financial results, achieving total revenues of $104 million, a 16% increase from Q2 2020. GAAP net income surged to $391 million, or $2.42 per share, compared to $25 million, or $0.16 per share, in the prior year. LINZESS, its primary product, saw an 18% rise in U.S. net sales to $259 million. Ironwood raised its 2021 guidance, expecting total revenue of $390 to $410 million, driven by increasing demand for LINZESS. The company also highlighted promising developments in its pipeline, including IW-3300, targeting visceral pain conditions.
Ironwood Pharmaceuticals (NASDAQ: IRWD) has appointed John Minardo as senior vice president and chief legal officer. He will serve on the Leadership Team, overseeing the Corporate Legal, Compliance, and IP teams, and report to CEO Thomas McCourt. Minardo brings over 20 years of legal experience in healthcare, previously serving in key legal roles at Seqirus and Novartis. His appointment is expected to enhance Ironwood's strategy and focus on improving treatments for gastrointestinal diseases.
Ironwood Pharmaceuticals (NASDAQ: IRWD) will host its second quarter 2021 investor update conference call on August 5, 2021, at 8:30 a.m. ET. Participants can join by dialing (833) 350-1432 (U.S. and Canada) or (647) 689-6932 (international) using conference ID 2598317. A replay will be available from 11:30 a.m. ET the same day until 11:59 p.m. ET on August 19, 2021. Ironwood specializes in GI diseases and is known for its leadership in linaclotide for treating IBS-C and CIC.
Ironwood Pharmaceuticals (NASDAQ: IRWD) announced the publication of Phase IIIb trial results for LINZESS (linaclotide) in the American Journal of Gastroenterology. The study demonstrated that 290 mcg of linaclotide significantly improved abdominal symptoms among adults with irritable bowel syndrome with constipation (IBS-C). Results showed a 29.7% decrease in abdominal scores compared to an 18.3% decrease with placebo, starting from week one. LINZESS was well-tolerated, with diarrhea being the most common adverse effect. The findings aim to enhance patient-doctor communication concerning IBS-C symptoms.
Ironwood Pharmaceuticals (NASDAQ: IRWD) has appointed Thomas McCourt as permanent CEO, having served as interim CEO since March 2021. His leadership aims to drive growth for LINZESS (linaclotide), a leading treatment for gastrointestinal conditions. Additionally, Gina Consylman will step down as CFO effective July 2, 2021, without any reported disagreements. The board commended her contributions, particularly during Ironwood's strategic transactions. McCourt expressed confidence in the company's financial stability and its future opportunities in the GI healthcare sector.
Ironwood Pharmaceuticals (NASDAQ: IRWD) announced an agreement with Teva Pharmaceuticals to license a generic version of LINZESS (linaclotide), allowing marketing to begin on March 31, 2029, pending FDA approval. This agreement settles all known ANDA filings for generic LINZESS. The patent coverage for LINZESS is preserved across three dosage strengths, reaffirming the company's plans to grow its franchise. The settlement will be submitted for review to regulatory authorities.
Ironwood Pharmaceuticals (Nasdaq: IRWD) has authorized a new share repurchase program allowing for the buyback of up to $150 million of its outstanding shares through December 2022. This initiative reflects Ironwood's disciplined capital allocation strategy and confidence in its financial position. The company aims to return cash to shareholders while continuing to focus on maximizing revenues from LINZESS® and developing innovative treatments for GI diseases. Management will determine the timing and method of repurchases based on market conditions.
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