Business
Ironwood Pharmaceuticals Initiates Apraglutide NDA Submission, Highlights Compelling New Data and Updates Corporate Structure to Position for the Future
– Data from open label extension study of apraglutide demonstrate further increase in patients achieving enteral autonomy – – Initiated rolling NDA
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Data from open label extension study of apraglutide demonstrate further increase in patients achieving enteral autonomy –\n\n\n– Initiated rolling NDA submission, now to include long-term extension data given continued clinical improvement over time, with submission completion expected in Q3 2025 –\n\n\n– Organizational restructuring positions the Company to realize the potential of apraglutide in SBS and long-term success in GI and rare disease –\n\n\n– Expects adjusted EBITDA excluding stock-based compensation of greater than $85 million in 2025, driven by strong LINZESS prescription demand growth and expense management to offset pricing headwinds –\n\n\n- Greg Martini named Chief Financial Officer and Tammi Gaskins named Chief Commercial Officer to further strengthen experienced leadership team in Ironwood’s next stage of growth –\n\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced a streamlined strategic focus on advancing and realizing the potential of apraglutide for the treatment of short bowel syndrome (“SBS”) patients who are dependent on parenteral support. In line with this strategic update, Ironwood will be reducing its workforce by approximately 50%. This reorganization is intended to position the company for long-term growth.\n\n\n“Ironwood’s long track record of success stems from our ability to be nimble as an organization by focusing on both significant medical needs and financial performance. While LINZESS continues to grow prescription demand, given the impact of ongoing pricing pressures, we are taking steps to reduce Ironwood costs that are predominantly associated with the brand. By doing so, we believe we can continue to generate profits and cash flows and support the successful development of apraglutide. LINZESS remains an important part of our strategy, along with continued investment in apraglutide for SBS patients who are dependent on parenteral support, which we believe will deliver value to our stakeholders and ultimately bring a new therapy to patients with great unmet need,” said Tom McCourt, chief executive officer of Ironwood.\n\n\n“We have made important progress by initiating our rolling new drug applicati...