Phase 3 trial – Talk Bio

Bayer Stock Rallies as Next-Gen Blood Thinner Achieves Phase 3 Success

2 days ago talkbio0Tagged Bayer, blood thinner, earnings, Phase 3 trial, rally

Bayer; stock rally; blood thinner; Phase 3 trial; pharmaceuticals; earnings

Roche’s Oral SERD Giredestrant Delays Early Breast Cancer Recurrence in Late-Stage Trial

1 week ago talkbio0Tagged Adjuvant Therapy, Disease-Free Survival, ER-positive, giredestrant, HER2-negative, Malignant neoplasm of breast, Oral SERD, Phase 3 trial, recurrence prevention, Roche (company)

Roche; oral SERD; giredestrant; Phase 3 trial; early breast cancer; ER-positive; HER2-negative; disease-free survival; adjuvant therapy; recurrence prevention

Diamyd Medical’s Pivotal Phase 3 Type 1 Diabetes Trial Clears Final Safety Review Ahead of Early Readout in March 2026

2 weeks ago talkbio0Tagged Accelerated, approval pathway, Data Safety, Diabetes Mellitus, Insulin-Dependent, DIAGNODE-3, Diamyd Medical, DSMB, fast-track designation, Genotype, HLA DR3-DQ2, interim readout, Monitoring Board, orphan drug designation, Phase 3 trial, precision therapy, safety review

Diamyd Medical; Type 1 Diabetes; Phase 3 trial; DIAGNODE-3; safety review; Data Safety Monitoring Board (DSMB); interim readout; March 2026; HLA DR3-DQ2 genotype; Orphan Drug Designation; Fast Track Designation; accelerated approval pathway; precision therapy

FDA Extends Review Period for Rhythm Pharmaceuticals’ Imcivree (Setmelanotide) in Acquired Hypothalamic Obesity

3 weeks ago talkbio0Tagged Agonist, amendment, goal, Hypothalamic structure, Imcivree, MC4R protein, human, PDUFA, Phase 3 trial, review extension, Rhythm Pharmaceuticals, setmelanotide, United States Food and Drug Administration

Imcivree; Rhythm Pharmaceuticals; FDA; review extension; acquired hypothalamic obesity; setmelanotide; PDUFA goal date; Phase 3 trial; major amendment; MC4R agonist

Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

3 weeks ago talkbio0Tagged asparagine, Atacicept, autoimmune kidney disease, Blackfoot language, File (record), IGA, IGA Glomerulonephritis, Kidney, Phase 3 trial, Proteinuria, Submission, United States Food and Drug Administration, UPCR, Vera Therapeutics

Vera Therapeutics; atacicept; Phase 3 trial; IgA nephropathy; proteinuria reduction; UPCR; FDA filing; BLA submission; ASN Kidney Week 2025; autoimmune kidney disease

Moderna Halts Development of CMV Vaccine After Phase 3 Failure

1 month ago talkbio0Tagged Clinical trial failure, Congenital Cytomegalovirus Infection, Cytomegalovirus Infections, Effectiveness, Moderna, mRNA-1647 cytomegalovirus vaccine, Phase 3 trial, Vaccines

Moderna; CMV vaccine; mRNA-1647; Phase 3 trial; Congenital cytomegalovirus; Vaccine efficacy; Clinical trial failure

Alector’s GSK-partnered dementia drug latozinemab fails in late-stage trial

1 month ago talkbio0Tagged Alector, Clinical trial failure, Drug Development, Latozinemab, Phase 3 trial, Pick Disease of the Brain, Presenile dementia, Progranulins, SmithKline Beecham

Alector; GSK; latozinemab; dementia; frontotemporal dementia; Phase 3 trial; clinical trial failure; progranulin; drug development

Roche Claims Its SERD Is Most Potent After Positive Breast Cancer Data Presented at ESMO 2025

1 month ago talkbio0Tagged ER-positive, giredestrant, HER2-negative, Malignant neoplasm of breast, Oral SERD, Phase 3 trial, Progression-Free Survival, Roche (company), Selective Estrogen Receptor Down Regulator

Roche; SERD; giredestrant; breast cancer; ESMO 2025; progression-free survival; oral SERD; ER-positive; HER2-negative; phase 3 trial

AstraZeneca and Daiichi Sankyo Report Landmark Results for Datroway in Triple-Negative Breast Cancer

2 months ago talkbio0Tagged ADC, AstraZeneca, Clinical Trials, Daiichi, Datopotamab deruxtecan, Datroway, Immunotherapy, Overall Survival, Pharmacotherapy, Phase 3 trial, Sankyo, therapeutic autologous dendritic cells, Triple Negative Breast Neoplasms, TROPION-Breast02

Datroway; Datopotamab deruxtecan; triple-negative breast cancer; ADC; AstraZeneca; Daiichi Sankyo; clinical trial; overall survival; chemotherapy; TROP2; phase 3 trial; immunotherapy; TROPION-Breast02

Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results

2 months ago talkbio0Tagged activin signaling, AKAP9 protein, human, Approved, Clinical Research, clinical worsening, early disease, Merck, PAH, Phase 3 trial, Sotatercept, United States Food and Drug Administration, Winrevair

Winrevair; Merck; HYPERION study; PAH; sotatercept; clinical worsening; early disease; activin signaling; FDA approval; Phase 3 trial