Ironwood Pharmaceuticals

• A newly released global clinical trials review provides extensive data on Interstitial Cystitis research, tracking trial numbers and enrollment trends across major countries worldwide. • The report categorizes trials by region, phase, status, and sponsorship, highlighting key pharmaceutical companies including Astellas Pharma, AbbVie, Johnson & Johnson, and Pfizer as prominent sponsors. • This comprehensive analysis serves as a strategic resource for stakeholders making investment decisions in IC research, offering insights into trial success rates and identifying optimal locations for clinical studies.

Ironwood Pharmaceuticals' stock plummeted by 37% after the FDA required a confirmatory Phase 3 trial for apraglutide, a treatment for short bowel syndrome with intestinal failure.

• Ironwood Pharmaceuticals has announced that a confirmatory Phase 3 trial will be required for apraglutide in short bowel syndrome with intestinal failure, following its $1 billion acquisition of VectivBio. • The GLP-2 analogue apraglutide was positioned as a potential blockbuster drug with projected annual sales of $1 billion, offering advantages over existing treatments like Takeda's Gattex through improved potency and weekly dosing. • Ironwood has engaged Goldman Sachs to explore strategic alternatives for the company while continuing the long-term extension study and working with the FDA on the design of the confirmatory trial.

• Tenax Therapeutics has appointed Gillian Andor as Vice President of Clinical Operations to support its Phase 3 program for oral levosimendan (TNX-103). • Ms. Andor brings over 20 years of experience in clinical operations, including NDA submissions and approvals, to accelerate the Phase 3 LEVEL study. • Her expertise will be crucial as Tenax Therapeutics advances oral levosimendan for pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). • The appointment signifies Tenax's commitment to strengthening its clinical development capabilities as it prepares for potential global regulatory filings.

The FDA approved mirikizumab (Omvoh) for Crohn's disease, marking its second approval in IBD after ulcerative colitis, based on positive Phase 3 trial results.

A new analysis indicates that linaclotide (Linzess) is effective in relieving functional constipation in children with neurodevelopmental disorders.