Statistical Significance
Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy
Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy
Clinical Roundup: Cardiff, VYNE and NewAmsterdam Report Key Trial Results in Multiple Disease Areas
Cardiff Oncology; VYNE; NewAmsterdam Pharma; clinical trial updates; onvansertib; metastatic colorectal cancer; Alzheimer’s disease; BROADWAY trial; oncology; statistically significant results
Bristol Myers’ schizophrenia drug Cobenfy stumbles as adjunctive treatment, denting blockbuster plan
Cobenfy, Schizophrenia, Antipsychotic Agents, Adjunctive Orthodontic Procedure, Myers, Statistical Significance, Improvement, Single Agent Therapy
Transcend’s neuroplastogen posts positive mid-stage results in PTSD
TSND-201, Post-Traumatic Stress Disorder, Placebos, Statistical Significance, CAPS-5
Mixed pivotal data for Pfizer, Arvinas’ protein degrader in breast cancer
Pfizer, Vepdegestrant, Clinical Trials, ESR1 gene, Statistical Significance, Improvement, Progression-Free Survival, Market
Lexicon stumbles on second batch of mixed results for pain drug
Dosage, lexicon, Statistical Significance
Oculis Announces Phase 2 Results for Licaminlimab in Dry Eye Disease, Despite Limited Statistical Significance
Oculis, Licaminlimab, Dry Eye Disease, Phase 2 Results, Statistical Significance
Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing
Intra-Cellular Therapies, Caplyta, Lumateperone, Major Depressive Disorder (MDD), Phase 3 Trial, Positive Results, Statistically Significant, Clinically Meaningful, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale for Severity of Illness (CGI-S), FDA Filing
Amylyx’s ALS Treatment Relyvrio Disappoints in Phase III PHOENIX Study, Company Considering Market Withdrawal
Amylyx, Relyvrio, ALS, Failure, Phase III PHOENIX Study, Market Withdrawal, Clinical Trial, Placebo, No Statistical Significance
Akero Reinforces Phase III FGF21 Analog Candidate with Enhanced Fibrosis Response Rates in MASH Data Update
Akero Therapeutics, FGF21 Analog, efruxifermin (EFX), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Phase IIb HARMONY Study, Fibrosis Response Rate, 96 Weeks, Statistically Significant Improvements