Phase 3 – Talk Bio

FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years

1 week ago talkbio0Tagged Analgesics, Non-Narcotic, Approved, Chronic pain, Clinical Trials, cyclobenzaprine, Fibromyalgia, Hairy Cell Leukemia, Phase 3, sublingual tablets, Tonix, Tonmya, United States Food and Drug Administration

Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

2 weeks ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025

2 weeks ago talkbio0Tagged biotech, Blackfoot language, Clinical Trials, Cylembio, Drops - Drug Form, etimupepimut, Hazard Ratio, Io satellite, Keytruda, melanoma, Overall Survival, P-Value, pembrolizumab, Phase 3, Progression-Free Survival, United States Food and Drug Administration

Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

2 weeks ago talkbio0Tagged B-cell depletion, BAFF‑R, cellular targeting, ESSDAI, ianalumab, NEPTUNUS-1, NEPTUNUS-2, Novartis, Phase 3, regulatory filings, safety profile, Sjögren 's disease

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

1 month ago talkbio0Tagged Capricor Therapeutics, Cardiomyopathies, Cell Therapy, Clinical Data, Complete, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3, Rejection, Response process, United States Food and Drug Administration

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

Amgen Adjusts Phase 3 Dosing for MariTide After Midstage Side Effects Concerns

2 months ago talkbio0Tagged Adverse event, amgen, Clinical Trials, Dosage, Escalation, gastric inhibitory polypeptide receptor, GLP-1 receptor, MariTide, Obesity, Phase 3, Vomiting

Amgen; MariTide; Phase 3; obesity treatment; dose escalation; vomiting; adverse events; clinical trial; GLP-1 receptor; GIP receptor

Novo Nordisk Plans Phase 3 Trials for Next-Generation Obesity Drug Amycretin

2 months ago talkbio0Tagged amycretin, Clinical Trials, Glucagon-Like Peptide 1, Nordisk, Obesity, Oral cavity, Phase 3, Receptors, Islet Amyloid Polypeptide, subcutaneous, Weight Loss

Novo Nordisk; amycretin; obesity; clinical trials; Phase 3; GLP-1; amylin receptor; weight loss; subcutaneous; oral

NewAmsterdam Reports Cholesterol Drug Obicetrapib May Slow Alzheimer’s Biomarker Buildup

3 months ago talkbio0Tagged Alzheimer 's disease, Apolipoprotein E4, Biological Markers, CETP, cholesterol ester transfer protein inhibitor, NewAmsterdam Pharma, Obicetrapib, p-tau217, Phase 3

NewAmsterdam Pharma; obicetrapib; cholesterol ester transfer protein inhibitor (CETP); Alzheimer’s disease biomarkers; p-tau217; ApoE4; BROADWAY trial; Phase 3

Ascletis’ Sagimet-Sourced Oral FASN Inhibitor Achieves All Endpoints in Pivotal Acne Study

3 months ago talkbio0Tagged Acne Vulgaris, Ascletis, Biosciences, Chinese study, clinical endpoints, Clinical Trials, Denifanstat, Inhibitor, Lesion, oral FASN, Phase 3, Sagimet

Ascletis; Sagimet Biosciences; denifanstat; oral FASN inhibitor; phase 3 clinical trial; acne vulgaris; clinical endpoints; lesion reduction; Chinese study

Azafaros Raises €132M in Series B to Fund Phase 3 Trials for Brain-Penetrant Drug

4 months ago talkbio0Tagged Azafaros, Brain-Penetrant Drug, Capital, Clinical Trials, Forbion, Growth, Jeito, Lysosomal Storage Diseases, neuro-metabolic diseases, Neurodegenerative Disorders, nizubaglustat, Phase 3, Series B funding

Azafaros; Series B funding; nizubaglustat; brain-penetrant drug; lysosomal storage disorders; rare neuro-metabolic diseases; phase 3 clinical trials; Jeito Capital; Forbion Growth; neurodegenerative diseases