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Ironwood Pharmaceuticals, Inc. IRWD announced that it has initiated the rolling new drug application (“NDA”) submission for the next-generation GLP-2 analog, apraglutide, for treating short bowel syndrome (“SBS”) patients who are dependent on parenteral support.
The NDA filing is expected to be completed in the third quarter of 2025.
The company also announced a corporate restructuring and a strategic reorganization. IRWD has decided to reduce its current workforce by almost 50% to achieve long-term growth.
Shares of Ironwood were down 11.6% yesterday following the announcement.
The stock has plunged 73.8% in the past year compared with the industry’s decline of 5.8%.
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More on IRWD's Rolling NDA for Apraglutide
Ironwood acquired the rights to develop and commercialize apraglutide following the acquisition of VectivBio in June 2023.
The phase III STARS study evaluated apraglutide for reducing parenteral support dependency in adult patients with short bowel syndrome with intestinal failure (SBS-IF). The open-label extension study, STARS Extend, also evaluated apraglutide for the given indication.
Data from the open-label extension study showed that treatment with apraglutide led to a further increase in patients achieving enteral autonomy, the goal of SBS patients who are dependent on parenteral support.
The extension study data showed that with longer exposure to apraglutide, a greater number of patients gradually reduced parenteral support.
Along with data from the STARS study, IRWD plans to include data from the long-term extension study in its NDA submission for apraglutide.
IRWD's Latest Strategic Reorganization
As part of the restructuring, the company is looking to reduce its existing workforce by almost 50%, primarily the field force.
The company also decided to close the phase II exploratory study, STARGAZE, which evaluated apraglutide for treating Graft-versus-Host Disease. This might have hurt investors' sentiments and resulted in the stock to decline yesterday.
Ironwood anticipated restructuring charges of around $20-$25 million to be incurred primarily in the first half of 2025.
Also, owing to the strategic reorganization, the company expects to make annual operating expense savings of approximately $55-$60 million.
IRWD has promoted Greg Martini to the position of senior vice president and chief financial officer. Martini previously served as vice president, Strategic Finance and Investor Relations for the company.
IRWD's 2025 Financial Guidance
Ironwood expects total revenues in the range of $260-$290 million for 2025. The Zacks Consensus Estimate for the metric is pegged at $329.7 million. This can also be a catalyst for the stock price decline yesterday.