Keros Therapeutics

GSK's Linerixibat Shows Significant Improvement in Cholestatic Pruritus for Primary Biliary Cholangitis Patients

14 days ago

• GSK's phase III GLISTEN trial demonstrates linerixibat significantly improves cholestatic pruritus (relentless itch) in patients with primary biliary cholangitis, addressing a major quality of life concern. • The late-breaking results were presented at the European Association for the Study of the Liver (EASL) Congress 2025, highlighting the potential for a new treatment option for this challenging symptom. • Primary biliary cholangitis is a chronic autoimmune liver disease that primarily affects women, with pruritus being one of the most debilitating symptoms impacting daily functioning and quality of life.

Keros Therapeutics Reports Positive Phase 1 Results for KER-065 in Duchenne Muscular Dystrophy Program

2 months ago

• KER-065 demonstrated favorable safety profile with no serious adverse events in Phase 1 trial, showing evidence of activin inhibition across multiple tissues of interest. • The novel ligand trap therapy showed promising biomarker changes including increased bone formation, fat mobilization, bone mineral density, and muscle mass, supporting its potential in treating DMD. • Keros plans to engage with regulatory authorities in Q3 2025 and aims to advance KER-065 into Phase 2 clinical trials for Duchenne muscular dystrophy by Q1 2026.

CARGO Therapeutics Halts Phase 2 FIRCE-1 Trial of Firi-cel for Large B-cell Lymphoma Due to Safety Concerns

4 months ago

• CARGO Therapeutics has discontinued its Phase 2 FIRCE-1 clinical trial of firi-cel in relapsed/refractory large B-cell lymphoma patients following CD19 CAR T-cell therapy failure. • An ad hoc safety analysis revealed unfavorable benefit-risk profile for firi-cel in the intended patient population, leading to the immediate termination of the study. • The trial discontinuation has prompted a securities fraud investigation by law firm Levi & Korsinsky, examining potential misleading statements to investors.

Keros Therapeutics Discontinues Phase 2 Trial of Cibotercept for Pulmonary Arterial Hypertension Due to Safety Concerns

4 months ago

• Keros Therapeutics halted its Phase 2 TROPOS trial of cibotercept (KER-012) for pulmonary arterial hypertension (PAH) due to pericardial effusion adverse events. • The decision follows a previous halt of higher dose arms and now includes the 1.5 mg/kg and placebo arms, leading to early termination of the trial. • Topline data from all treatment arms will still be presented in Q2 2025, with patients monitored through end-of-trial visits. • Cibotercept, a TGF-β ligand inhibitor, aimed to improve pulmonary hemodynamics and exercise capacity in PAH patients but showed unexpected safety issues.

BioAge Labs Faces Securities Lawsuits Following Azelaprag Trial Discontinuation

5 months ago

• BioAge Labs is under investigation for potential securities law violations after discontinuing its Phase 2 trial of azelaprag due to safety concerns. • Multiple law firms have announced investigations and class action lawsuits on behalf of investors who suffered losses following the trial halt. • The STRIDES Phase 2 trial was terminated after liver transaminitis was observed in participants, leading to a significant drop in BioAge's stock price. • Investors who purchased BioAge securities during the IPO period have until March 10, 2025, to seek lead plaintiff status in the class action.

Keros Therapeutics Pauses Cibotercept Dosing in Higher Dose Arms of Phase 2 PAH Trial Due to Pericardial Effusion

5 months ago

• Keros Therapeutics halts dosing in the 3.0 mg/kg and 4.5 mg/kg arms of its Phase 2 TROPOS trial of cibotercept for pulmonary arterial hypertension (PAH) after detecting pericardial effusion. • The decision follows a safety review and consultation with an independent Data Monitoring Committee; dosing continues in the 1.5 mg/kg arm. • Keros is working with investigators and the FDA to understand the findings and expects to share topline data from all trial arms in Q2 2025. • Despite this setback, Keros will continue safety and efficacy data collection for all treatment arms in the TROPOS trial.

Iron Deficiency Anemia Therapeutics Market Shows Promise with Emerging Therapies

6 months ago

• The iron deficiency anemia (IDA) therapeutics market is expected to grow, with a market size of around USD 1,400 million in the 7MM in 2023. • Emerging therapies like MPB-1514 (MegaPro Biomedical) and IDAX (Nemysis) show promise in improving treatment options for IDA patients. • Clinical trials are underway to evaluate the efficacy of novel oral iron formulations like IHAT for increasing serum ferritin levels. • Oral iron therapy remains the first-line treatment, but intravenous iron products like Monoferric (Pharmacosmos) offer alternatives.