BOSTON - Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) has announced new data from its Phase III clinical trial, STARS, which evaluated the treatment effect of apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF). The findings, to be presented at the American College of Gastroenterology 2024 Annual Scientific Meeting, show a consistent treatment effect of apraglutide across various demographic subgroups. These results support the clinical profile of the investigational once-weekly GLP-2 analog and reinforce its safety and tolerability, with low incidences of adverse events and injection site reactions.
The STARS trial is the largest Phase III trial conducted for SBS-IF to date and the first to pre-specify patient stratification based on remnant bowel anatomy. The trial met its primary endpoint, showing a significant relative change from baseline in weekly parenteral support volume at week 24 compared to placebo. Ironwood expects to complete the U.S. regulatory submission for apraglutide in Q1 2025.
SBS-IF is a rare, chronic condition where patients are dependent on parenteral support. Apraglutide has the potential to be the first once-weekly treatment option for these patients, a significant advancement given the current treatment landscape. Ironwood's commitment to addressing the needs of the SBS community is evident in their focus on educating about the compound's potential across adult patient profiles, as stated by Michael Shetzline, M.D., Ph.D., chief medical officer at Ironwood.
In addition to the apraglutide data, Ironwood presented new findings on linaclotide, a treatment for chronic idiopathic constipation and irritable bowel syndrome with constipation. The data highlighted linaclotide's efficacy and safety across patient demographics and body mass index categories.
The information in this article is based on a press release statement from Ironwood Pharmaceuticals.
In other recent news, Ironwood Pharmaceuticals has made significant strides in its financial and operational activities. The company has expanded its secured revolving credit facility from $500 million to $550 million, a move facilitated by Wells Fargo Bank and other lenders. This change extends the maturity date of the facility to December 31, 2028. Ironwood Pharmaceuticals has also received a Market Outperform rating from JMP Securities and a Market Perform rating from Leerink Partners.
In addition to these financial developments, Ironwood Pharmaceuticals has opted not to exercise its option to in-license CNP-104 from COUR Pharmaceutical Development Company following a review of Phase II clinical study data. The company has also seen a 10% year-over-year increase in prescription volume for its leading product, LINZESS, despite a downward revision in its FY2024 guidance due to a one-time negative revenue adjustment.
Ironwood Pharmaceuticals' acquisition of VectivBio in 2023 and the anticipated approval of apraglutide, a treatment for short bowel syndrome, by early 2026 have been noted by Leerink Partners. Piper Sandler and Wells Fargo analysts have reaffirmed their positive outlook on the prospects of apraglutide. The company has also announced the promotion of Sravan K. Emany to Senior Vice President, Chief Operating Officer, and Chief Financial Officer.
InvestingPro Insights
As Ironwood Pharmaceuticals (NASDAQ: IRWD) advances its clinical trials and prepares for regulatory submissions, investors should consider the company's current financial position and market performance. According to InvestingPro data, Ironwood's market capitalization stands at $632.57 million, reflecting the market's current valuation of the company's potential.
Despite the promising clinical results, Ironwood's stock has experienced significant pressure recently. The company's shares are trading near their 52-week low, with a substantial 43.75% decline over the past three months. This downturn could present an opportunity for investors who believe in the long-term potential of Ironwood's pipeline, particularly apraglutide for SBS-IF treatment.
InvestingPro Tips highlight that Ironwood is trading at a low P/E ratio relative to its near-term earnings growth, suggesting potential undervaluation. Additionally, the company's valuation implies a strong free cash flow yield, which could be attractive to value-oriented investors.
It's worth noting that analysts anticipate a sales decline in the current year, which aligns with the revenue growth of -6.25% reported in the last twelve months. However, the company remains profitable, with a gross profit margin of 67.95% and an operating income margin of 29.79% for the same period.
For those interested in a deeper analysis, InvestingPro offers 11 additional tips for Ironwood Pharmaceuticals, providing a more comprehensive view of the company's financial health and market position.
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