Ironwood - IRWD STOCK NEWS

Ironwood Pharmaceuticals (Nasdaq: IRWD) announced presentations at the 2025 Digestive Disease Week® (DDW) meeting in San Diego, focusing on two key areas:

1. Short Bowel Syndrome (SBS): Real-world data analysis on the adoption of new ICD-10 codes for SBS patients dependent on parenteral support. These codes, approved by CMS in October 2023, aim to improve disease recognition and patient care. Ironwood is developing apraglutide, a next-generation GLP-2 analog for SBS treatment.

2. Pediatric Studies: Results from the first completed Phase III study of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation (IBS-C). Additional presentations include research on the connection between pediatric functional constipation and chronic idiopathic constipation in young adults.

The presentations will take place May 3-6, featuring research from leading medical institutions including Mount Sinai Medical Center, University of Miami Health System, Cincinnati Children's, and Connecticut Children's.

Ironwood Pharmaceuticals (IRWD) announced that the FDA requires a confirmatory Phase 3 trial for apraglutide, their treatment for short bowel syndrome with intestinal failure (SBS-IF). This requirement emerged after pharmacokinetic analysis revealed that the exposure and dose delivered in the STARS Phase 3 trial were lower than planned due to preparation and administration issues.

Despite strong safety and efficacy data from the STARS Phase 3 trial, which was the largest SBS-IF trial to date, and positive results showing 27 patients achieving enteral autonomy in the long-term extension trial, the FDA's feedback indicates additional clinical validation is necessary. The company plans to work with the FDA on designing the confirmatory trial while continuing the long-term extension study.

In response to this development, Ironwood has engaged Goldman Sachs to explore strategic alternatives to maximize stockholder value while continuing to advance apraglutide's development.

Ironwood Pharmaceuticals (Nasdaq: IRWD) has received a non-compliance notification from Nasdaq on March 21, 2025, due to delayed filing of its 2024 Annual Report (Form 10-K). The notification is a standard procedure and does not immediately affect the company's Nasdaq listing.

The biotechnology company, which focuses on gastrointestinal and rare diseases treatments, has been given 60 calendar days until May 20, 2025, to submit a compliance plan to Nasdaq. Ironwood expects to file the 2024 Form 10-K soon and regain compliance with Nasdaq Listing Rule 5250(c)(1).

Ironwood Pharmaceuticals (IRWD) reported its Q4 and full year 2024 results, achieving revenue of $351.4 million and GAAP net income of $1.8 million. The company's flagship product LINZESS® showed strong prescription demand growth of 11% year-over-year for 2024.

Key highlights include positive data from the apraglutide open-label extension study, with 27 patients achieving enteral autonomy. The company initiated a rolling NDA submission, expected to complete in Q3 2025. LINZESS U.S. net sales were $916.3 million for 2024, though showing a 15% decrease from 2023.

The company announced a strategic reorganization, including a 50% workforce reduction, primarily affecting the field force. This restructuring is expected to generate $55-60 million in annual operating expense savings and result in charges of $20-25 million in early 2025.

Ironwood Pharmaceuticals (Nasdaq: IRWD) has announced its upcoming fourth quarter and full year 2024 investor update conference call and webcast, scheduled for Thursday, February 27, 2025, at 8:30 a.m. Eastern Time.

Participants can join via phone by dialing (888) 596-4144 (U.S. and Canada) or (646) 968-2525 (international) using conference ID 2530602. The webcast will be accessible through the Investors section of Ironwood's website.

A replay will be available from approximately 11:30 a.m. Eastern Time on February 27 until 11:59 p.m. Eastern Time on March 13, 2025. Replay access numbers are (800) 770-2030 (U.S. and Canada) or (609) 800-9909 (international). The webcast recording will remain available on the company's website for one year after the call.

Ironwood Pharmaceuticals (NASDAQ: IRWD) announced significant corporate restructuring and updates on its apraglutide drug development. The company has initiated a rolling NDA submission for apraglutide in short bowel syndrome (SBS), with completion expected in Q3 2025. New data from the open-label extension study showed increased patient success in achieving enteral autonomy.

The company is implementing a 50% workforce reduction, primarily affecting its field force, to optimize costs while maintaining LINZESS growth and supporting apraglutide development. The restructuring is expected to generate $55-60 million in annual operating expense savings.

For FY2025, Ironwood projects LINZESS U.S. net sales of $800-850 million, total revenue of $260-290 million, and adjusted EBITDA exceeding $85 million. The company has also appointed Greg Martini as CFO and Tammi Gaskins as CCO to strengthen its leadership team.

Ironwood Pharmaceuticals (Nasdaq: IRWD) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's management will engage in a fireside chat on Wednesday, December 4, 2024, at 12:30 p.m. ET, taking place at the Lotte New York Palace.

The event will be accessible via live webcast through the Investors section of Ironwood's website. Following the conference, a replay of the fireside chat will be made available on the company's website at www.ironwoodpharma.com.

Ironwood Pharmaceuticals (Nasdaq: IRWD) has announced its participation in the upcoming Jefferies London Healthcare Conference. Sravan Emany, Chief Operating Officer and Chief Financial Officer, will lead a fireside chat on Wednesday, November 20, 2024, at 7:30 a.m. GT at the Waldorf Hilton in London. The event will be accessible via live webcast through the Investors section of Ironwood's website, with a replay available for one year following the conference.

Ironwood Pharmaceuticals reported Q3 2024 results with total revenue of $91.6M, down from $113.7M in Q3 2023. LINZESS prescription demand grew 13% year-over-year, though U.S. net sales decreased 19% to $225.5M. The company maintains its 2024 financial guidance with expected U.S. LINZESS net sales of $900-950M and total revenue of $350-375M. GAAP net income was $3.6M ($0.02 per share) compared to $15.3M ($0.10 per share) in Q3 2023. The company remains on track to complete apraglutide NDA submission in Q1 2025.