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) will present pivotal Phase III data on linaclotide for treating functional constipation in children aged 6-17 at the 2023 Digestive Disease Week® (DDW) from May 6-9 in Chicago, IL. This condition affects around 6 million children in the U.S. An oral presentation will detail a clinical trial assessing the efficacy and safety of linaclotide 72 mcg in this age group. Four poster sessions will present further efficacy and safety data. Notably, the FDA granted Priority Review for a supplemental New Drug Application (sNDA) for linaclotide in pediatric use, with a PDUFA date set for June 14, 2023. Currently, there are no FDA-approved therapies for pediatric functional constipation. Ironwood continues to expand its research in this area.
Ironwood Pharmaceuticals (Nasdaq: IRWD) will host its first quarter 2023 investor update conference call on May 4, 2023, at 8:30 a.m. Eastern Time. Participants can join by calling (888) 330-2384 (U.S./Canada) or (240) 789-2701 (international) with conference ID 4671230. The call will also be accessible via webcast on the company's website, which is recommended to access at least 15 minutes prior to the start time. A replay of the call will be available starting at 11:30 a.m. Eastern Time on the same day, and can be accessed until May 18, 2023, by calling (800) 770-2030 (U.S./Canada) or (647) 362-9199 (international), also using conference ID 4671230. Ironwood Pharmaceuticals is focused on advancing treatments for gastrointestinal diseases.
Ironwood Pharmaceuticals (Nasdaq: IRWD) announced its participation in two upcoming investor conferences:
- Cowen 43rd Annual Health Care Conference on March 6, 2023, at 9:10 a.m. ET in Boston.
- Barclays Global Healthcare Conference on March 14, 2023, at 8:00 a.m. ET in Miami.
Live webcasts of these events will be available on Ironwood's website, with replays accessible for 14 days post-conference. As a leading gastrointestinal healthcare company, Ironwood focuses on advancing treatments for GI diseases, notably through its product LINZESS® for managing IBS-C and CIC.
Ironwood Pharmaceuticals (Nasdaq: IRWD) announced its 2022 financial results, reporting a GAAP net income of $175 million and an adjusted EBITDA of $252 million. The company ended 2022 with $656 million in cash. LINZESS® U.S. net sales were $1,002 million, slightly down from 2021. The FDA granted priority review for LINZESS in pediatric patients, with a PDUFA date of June 14, 2023. The company anticipates a 3% to 5% growth in LINZESS net sales for 2023, with total revenue projections of $420 to $435 million. The fourth quarter saw total revenues of $107.2 million, a decrease from the previous year.
Ironwood Pharmaceuticals announced that the FDA has granted Priority Review to its supplemental New Drug Application for LINZESS (linaclotide), targeting children aged 6-17 with functional constipation. The FDA set a Prescription Drug User Fee Act (PDUFA) date of June 14, 2023, marking a four-month acceleration from the standard review timeline. If approved, LINZESS will be the first FDA-approved prescription therapy for this condition in the pediatric population, potentially impacting about 6 million children in the U.S. The application is based on a Phase III study involving 330 participants, which showed significant improvements in bowel movement frequency and stool consistency.
Ironwood Pharmaceuticals (NASDAQ: IRWD) will conduct its fourth quarter and full year 2022 investor update conference call on February 16, 2023, at 8:30 a.m. Eastern Time. Interested participants can join by dialing (888) 330-2384 for the U.S. and Canada, or (240) 789-2701 for international calls, using conference ID 4671230. The call will be accessible for replay starting the same day at 11:30 a.m. Eastern Time until March 2, 2023. Ironwood specializes in gastrointestinal healthcare and is known for its leading product, LINZESS®, aimed at treating IBS-C and CIC.
Ironwood Pharmaceuticals (Nasdaq: IRWD) announced its updated financial guidance for 2022 and expectations for 2023 amidst its presentation at the J.P. Morgan Healthcare Conference. The company submitted a supplemental NDA for LINZESS® to treat functional constipation in pediatric patients. Ironwood anticipates LINZESS prescription growth in the high single digits for 2023 and expects adjusted EBITDA to exceed $250 million. The total revenue projection for 2023 is $420-$435 million, with net sales growth for LINZESS estimated at 3% to 5%.
Ironwood Pharmaceuticals (Nasdaq: IRWD), a leader in gastrointestinal healthcare, announced that CEO Tom McCourt will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 9:00 a.m. PT in San Francisco, CA. The live audio webcast can be accessed via the company's website, with a replay available for 14 days post-conference. Ironwood is renowned for its work on LINZESS®, a top medication for treating IBS-C and CIC. The company continues to innovate in GI treatments and aims to redefine care standards for patients.
Ironwood Pharmaceuticals (Nasdaq: IRWD) will participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, at 4:30 p.m. ET in New York. The event will be accessible via a live webcast on Ironwood's website, where a replay will also be available for 14 days post-conference. Located in Boston, Massachusetts, Ironwood specializes in gastrointestinal healthcare, notably for conditions like IBS-C and CIC, led by its flagship product LINZESS.
Ironwood Pharmaceuticals reported a strong Q3 2022, with a 10% year-over-year increase in LINZESS prescription demand, reaching over 1 million prescriptions in a quarter for the first time. The company plans to submit a supplemental New Drug Application (sNDA) to the FDA for LINZESS in pediatric patients by the end of 2022. Financial highlights include a GAAP net income of $50 million and adjusted EBITDA of $69 million. Ironwood maintains its guidance for 2022, expecting total revenue between $420 million and $430 million.
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