Ironwood Pharma (IRWD) Initiates Apraglutide NDA Submission
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Ironwood Pharmaceuticals Initiates Apraglutide NDA Submission, Highlights Compelling New Data and Updates Corporate Structure to Position for the Future
January 29, 2025 4:05 PM ESTData from open label extension study of apraglutide demonstrate further increase in patients achieving enteral autonomy
Initiated rolling NDA submission, now to include long-term extension data given continued clinical improvement over time, with submission completion expected in Q3 2025
Organizational restructuring positions the Company to realize the potential of apraglutide in SBS and long-term success in GI and rare disease
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... More
