Phase 3 Clinical Trials
Ultragenyx Advances Gene Therapy for Glycogen Storage Disease Type Ia Following Phase 3 Success
Ultragenyx, gene therapy, glycogen storage disease type Ia, DTX401, Phase 3 study, GlucoGene, rare genetic diseases
FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval
FDA, Dupixent, COPD, EMA, Regeneron, Sanofi, Priority Review, PDUFA, Boreas, Notus, Phase III Trials
Insmed’s Stocks Skyrocket Following Triumphant Phase III Results for Brensocatib in Bronchiectasis Treatment
Insmed, brensocatib, bronchiectasis, Phase III trial, lung disease, stock surge, New Drug Application, FDA approval, market value
NS Pharma’s Viltepso Fails Confirmatory Phase III Trial for Duchenne Muscular Dystrophy Treatment
Viltepso, NS Pharma, Duchenne muscular dystrophy, RACER53 study, viltolarsen, FDA approval, confirmatory trial, phase III trial, DMD treatment
Novartis Achieves Success in Two Phase III Trials for Rare Kidney Diseases, Eyes Regulatory Submissions
Novartis, Phase III trials, Rare kidney diseases, IgA nephropathy, C3 glomerulopathy, Regulatory submissions
Tremfya Phase III Maintenance Study Results Presented by J&J for Ulcerative Colitis Treatment
J&J, Johnson & Johnson, Tremfya, guselkumab, Phase III trial, maintenance study, ulcerative colitis, inflammatory bowel disease, treatment, efficacy, safety, remission.
Cytokinetics’ Phase III Trials Show Promise in Challenging Cardiomyopathy Treatment Dominated by BMS
Cytokinetics, Phase III trials, cardiomyopathy, Bristol-Myers Squibb (BMS), heart failure treatment, myosin inhibitors, omecamtiv mecarbil, clinical data, heart muscle contraction, cardiovascular disease.
AstraZeneca’s Imfinzi Demonstrates Survival Benefit in Limited-Stage Small Cell Lung Cancer Study
AstraZeneca, Imfinzi (durvalumab), Small Cell Lung Cancer (SCLC), Limited-stage SCLC, ADRIATIC Phase III study, Overall Survival (OS), Progression-Free Survival (PFS), Immunotherapy
Pfizer Discontinues Phase III Trial for Sickle Cell Treatment Amid Challenges in Patient Recruitment
Pfizer, Sickle Cell Disease, Phase III Study, Inclacumab, Poor Accrual, Recruitment Challenges, THRIVE Program, ClinicalTrials.gov, Gene Therapies
Axsome Therapeutics’ Small Molecule AXS-12 Successful in Phase III Narcolepsy Trial
Axsome Therapeutics, AXS-12 (reboxetine), Phase III trial, Narcolepsy, Cataplexy reduction, Improved cognition/ memory/ sleepiness severity, Safety profile