IRWD Begins Apraglutide NDA Submission, Announces Job Cuts, Stock Falls

Core Viewpoint - Ironwood Pharmaceuticals has initiated a rolling new drug application for apraglutide to treat short bowel syndrome, while also undergoing significant corporate restructuring, including a workforce reduction of nearly 50% [1][2][7]. Group 1: Drug Development and NDA Submission - The rolling NDA submission for apraglutide is aimed at treating short bowel syndrome patients dependent on parenteral support, with completion expected in Q3 2025 [1]. - Ironwood acquired the rights to apraglutide through the acquisition of VectivBio in June 2023, and the drug has shown promising results in phase III studies [3]. - Data from the STARS Extend study indicated that longer exposure to apraglutide led to an increased number of patients achieving enteral autonomy, which is a key goal for SBS patients [4]. Group 2: Corporate Restructuring - The company plans to reduce its workforce by almost 50%, primarily affecting the field force, and will close the phase II exploratory study STARGAZE [2][7]. - Anticipated restructuring charges are estimated to be around $20-$25 million, primarily incurred in the first half of 2025 [7]. - The strategic reorganization is expected to yield annual operating expense savings of approximately $55-$60 million [8]. Group 3: Financial Guidance and Market Performance - Ironwood expects total revenues in the range of $260-$290 million for 2025, which is below the Zacks Consensus Estimate of $329.7 million [9]. - U.S. sales of Linzess are projected to be between $800-$850 million, and the company anticipates delivering adjusted EBITDA of over $85 million in 2024 [9]. - Following the announcements, Ironwood's shares fell by 11.6% and have decreased by 73.8% over the past year, contrasting with a 5.8% decline in the industry [2].