Clinical Trials
Lexeo Therapeutics Reports Promising Early Data for Gene Therapy LX2006 in Friedreich Ataxia Cardiomyopathy
Lexeo Therapeutics, LX2006, Gene Therapy, Friedreich Ataxia, Cardiomyopathy, Clinical Trials, Rare Genetic Disorders
Pfizer Advances Development of Once-Daily Oral GLP-1 Receptor Agonist Danuglipron for Obesity Treatment
Pfizer, Danuglipron, GLP-1 Receptor Agonist, Obesity Treatment, Once-Daily Formulation, Clinical Trials, Weight Loss Medication
UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data
UniQure, Huntington’s disease, gene therapy, AMT-130, FDA, RMAT designation, Phase I/II clinical trials, neurodegenerative disorder, neurofilament light (NfL), disease progression, composite Unified Huntington’s Disease Rating Scale (cUHDRS).
TRACON Pharmaceuticals Discontinues Envafolimab Development, Explores Strategic Options
TRACON Pharmaceuticals, Envafolimab, Oncology, Clinical Trial, Strategic Options, Mergers, Acquisitions, Asset Sales
Lykos Faces Setback as ICER Concludes Insufficient Evidence for MDMA-Based PTSD Treatment
Lykos Therapeutics, MDMA, PTSD, ICER, Insufficient Evidence, Clinical Trials, FDA Approval
FDA Publishes Updated Draft Guidance on Clinical Trial Diversity
FDA, Clinical Trials, Diversity, Inclusion, Medical Products, Racial and Ethnic Representation
Fractyl Highlights GLP-1 Gene Therapy Potential, Delays Clinical Trials to 2025
Fractyl, GLP-1 gene therapy, clinical trials, diabetes, ADA24
FDA Halts BioNTech-MediLink ADC Trial Due to ‘Significant Risk of Illness or Injuries’
FDA, BioNTech, MediLink, ADC, Clinical Trial, Safety Concerns, Cancer Treatment
Kyverna’s CAR-T Relapse in Lupus Dents Autoimmune Hopes Amid Biotech Gold Rush
Kyverna, CAR-T, Lupus, Autoimmune Disease, Biotech, Gold Rush, Relapse, Clinical Trials, Gene Therapy
FDA Places Partial Clinical Hold on Zentalis’ Azenosertib Cancer Studies Following Two Sepsis Deaths
Zentalis Pharmaceuticals, azenosertib, FDA, partial clinical hold, cancer studies, sepsis deaths, WEE1 inhibitor, clinical trials, patient safety