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Ironwood Pharmaceuticals (IRWD) is a leader in gastrointestinal therapeutics, pioneering treatments for chronic conditions like IBS-C and CIC. This dedicated news hub provides investors and healthcare professionals with timely updates on clinical developments, regulatory milestones, and strategic initiatives.
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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.
Ironwood Pharmaceuticals (Nasdaq: IRWD) will host its third quarter 2022 investor update conference call on November 3, 2022, at 8:30 a.m. ET. Participants can join by calling (888) 330-2384 for U.S. and Canada or (240) 789-2701 internationally, using conference ID 4671230. A replay will be available starting the same day at 11:30 a.m. ET until November 17, 2022. The archived webcast will be accessible on Ironwood’s website for 14 days post-call. Ironwood focuses on advancing gastroenterological treatments, especially for IBS-C and CIC.
Ironwood Pharmaceuticals announced positive topline results from a Phase III trial of linaclotide in pediatric patients aged 6-17 with functional constipation (FC). The study met its primary and secondary endpoints, demonstrating significant improvements in spontaneous bowel movements and stool consistency compared to placebo. Linaclotide was generally well-tolerated, with diarrhea being the most common side effect. There are currently no FDA approved pediatric treatments for FC, affecting 4-6 million children in the U.S. Ironwood and partner AbbVie may file for a supplemental New Drug Application (sNDA).
Ironwood Pharmaceuticals (Nasdaq: IRWD) will participate in a fireside chat at the 2022 Wells Fargo Healthcare Conference scheduled for September 8, 2022, at 8:00 a.m. ET in Everett, MA. A live webcast will be available on the company's website, with a replay accessible for 14 days post-conference. Ironwood is renowned for its gastrointestinal healthcare focus, particularly with LINZESS®, a leading treatment for IBS-C and CIC. Founded in 1998 and headquartered in Boston, Massachusetts, Ironwood aims to redefine GI care.
Ironwood Pharmaceuticals reported its Q2 2022 results, showcasing a 9% year-over-year growth in LINZESS prescription demand. Despite this, total revenues decreased to $97.2 million from $104.0 million in Q2 2021, with GAAP net income dropping significantly to $37 million from $391 million. The company completed its share repurchase program and repaid $120.7 million in convertible notes. Ironwood reiterated its guidance for 2022, projecting low single-digit U.S. LINZESS net sales growth and total revenue between $420 million and $430 million.
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