Ironwood Pharmaceuticals

New Global Review Reveals Comprehensive Landscape of Interstitial Cystitis Clinical Trials in 2025

3 days ago

• 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 Faces Setback as FDA Requires Additional Phase 3 Trial for Apraglutide

a month ago

• 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. • Pharmacokinetic analysis revealed that exposure and dosing in the original STARS Phase 3 trial were lower than intended due to preparation and administration issues. • Despite promising efficacy data showing 27 patients achieving enteral autonomy in the long-term extension trial, the company has engaged Goldman Sachs to explore strategic alternatives.

Ironwood Pharmaceuticals Faces Setback in Apraglutide Development for Short Bowel Syndrome

a month ago

• 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.

Ironwood Pharmaceuticals Cuts 50% of Workforce Amid Lower Revenue Projections, Focuses on Apraglutide Development

4 months ago

Ironwood Pharmaceuticals announces a major restructuring, including a 50% workforce reduction and discontinuation of the STARGAZE trial, as 2025 revenue guidance falls below analyst expectations. The company maintains focus on advancing apraglutide for short bowel syndrome, which showed promising Phase III results with a 25% reduction in parenteral support needs.

Endometriosis Clinical Trial Pipeline Shows Promise with 20+ Therapies in Development

4 months ago

• The endometriosis clinical trial landscape is robust, featuring over 15 companies developing more than 20 potential therapies. • Recent clinical trial activity includes positive Phase II results for Hope Medicine's HMI-115 and TiumBio's Merigolix, alongside Lisata Therapeutics' preclinical research. • Key companies like Kissei Pharmaceutical, Mithra Pharmaceuticals, and Organon are advancing novel treatments, including Linzagolix and Estelle, to address unmet needs. • These emerging therapies aim to improve pain management and overall outcomes for the estimated 190 million women affected by endometriosis worldwide.

Tenax Therapeutics Appoints Gillian Andor as VP of Clinical Operations to Bolster Phase 3 Program

4 months ago

• 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.

GI Advances: FDA Approvals, Novel Research Shape Gastroenterology in Early 2025

5 months ago

• 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 tentative FDA approval was granted for a generic version of rifaximin for IBS-D, offering a potential cost-effective alternative pending the resolution of ongoing litigation. • Ironwood initiated a rolling NDA submission for apraglutide, aiming to address short bowel syndrome by reducing dependence on parenteral support. • Research indicates fecal microbiota transplantation (FMT) shows promise in treating type 1 diabetes and gastroenteropathy, improving patient quality of life.

Assertio Therapeutics Receives Buy Rating Following Positive Clinical Trial Results

5 months ago

H.C. Wainwright reaffirms a Buy rating for Assertio Therapeutics, citing promising clinical trial outcomes for ROLVEDON in early-stage breast cancer treatment, with a price target of $4.00.

Cytokinetics' Aficamten Advances in Regulatory Review for Obstructive Hypertrophic Cardiomyopathy

6 months ago

• The EMA has validated Cytokinetics' Marketing Authorization Application (MAA) for aficamten, a cardiac myosin inhibitor, for treating obstructive hypertrophic cardiomyopathy (HCM). • The FDA has accepted the New Drug Application (NDA) for aficamten with a PDUFA target action date of September 26, 2025, and no advisory committee meeting is planned. • Aficamten significantly improved exercise capacity and clinical outcomes in the SEQUOIA-HCM Phase 3 trial, supporting regulatory submissions in the U.S., Europe, and China.

Linaclotide Shows Promise for Functional Constipation in Children with Neurodevelopmental Disorders

6 months ago

• A new analysis indicates that linaclotide (Linzess) is effective in relieving functional constipation in children with neurodevelopmental disorders. • The study found that linaclotide's benefits in this specific population mirrored those observed in the broader pediatric functional constipation trial. • High adherence rates (over 90%) to linaclotide were observed, suggesting good tolerability and acceptance among children with neurodevelopmental disorders. • The incidence of diarrhea, a common side effect, was similar to that seen with other laxatives, indicating a manageable safety profile.

Calluna Pharma Appoints Mark Gaffney as CEO, Advances CAL101 Program

7 months ago

• Calluna Pharma has appointed Mark Gaffney as Chief Executive Officer to lead the company's strategic initiatives and advance its pipeline. • Gaffney's appointment coincides with Calluna's lead candidate, CAL101, nearing completion of its Phase 1 program for inflammatory and fibrotic diseases. • Mark Altmeyer has also been appointed as the Independent Chair of the Board, bringing extensive leadership experience in the pharmaceutical and biotech sectors. • Calluna Pharma is focused on developing first-in-class antibodies targeting the root causes of inflammation and fibrosis.

Tulisokibart Shows Promise in Treating Moderate to Severe Ulcerative Colitis

8 months ago

• A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis. • The study utilized a genetic-based diagnostic test to identify patients more likely to respond to tulisokibart, showing improved remission rates in this subgroup. • Tulisokibart modulates inflammation and the body's anti-inflammatory mechanisms, offering a novel approach compared to existing IBD treatments that can exacerbate inflammation. • The safety profile of tulisokibart appeared comparable to placebo, with similar rates of adverse events, supporting its potential as a valuable new treatment option.