Phase 3 trial – Talk Bio

Neurocrine’s VMAT2 Inhibitor Valbenazine Fails in Phase 3 Trial for Dyskinetic Cerebral Palsy

3 weeks ago talkbio0Tagged Athetoid cerebral palsy, Chorea, KINECT-DCP, Neurocrine, Phase 3 trial, valbenazine, VMAT2 Inhibitor

Neurocrine; valbenazine; VMAT2 inhibitor; dyskinetic cerebral palsy; KINECT-DCP; Phase 3 trial; chorea

Moderna Lands CEPI as New Backer for Its Pandemic Flu (H5 Bird Flu) Program

3 weeks ago talkbio0Tagged CEPI, coalition, Epidemic Preparedness Innovations, Funding, H5 bird flu, Moderna, mRNA Vaccine, pandemic influenza, pandemic preparedness, Phase 3 trial, Vaccine Development

Moderna; CEPI; Coalition for Epidemic Preparedness Innovations; pandemic influenza; H5 bird flu; mRNA vaccine; Phase 3 trial; pandemic preparedness; vaccine development; funding

Lilly seeks rapid FDA approval for oral GLP-1 orforglipron after positive obesity “switching” study

3 weeks ago talkbio0Tagged Approved, Clinical Trials, Eli, Glucagon-Like Peptide 1, injectable incretins, national priority review voucher, Obesity, Oral cavity, orforglipron, Phase 3 trial, United States Food and Drug Administration, Wegovy, weight maintenance, Zepbound

Eli Lilly; orforglipron; oral GLP-1; FDA approval; national priority review voucher; ATTAIN-MAINTAIN trial; obesity treatment; weight maintenance; Zepbound; Wegovy; injectable incretins; Phase 3 trial

‘Au Revoir TIGIT’: Gilead, Arcus Cut Gastro Cancer Drug After Late-Stage Failure

4 weeks ago talkbio0Tagged Arcus Biosciences, casdatifan, domvanalimab, EDGE-Gastric, Esophageal Neoplasms, Failure (biologic function), Gilead Sciences, immuno-oncology, Malignant neoplasm of stomach, nivolumab, Opdivo, Overall Survival, Phase 3 trial, STAR-221, TIGIT gene, zimberelimab

domvanalimab; TIGIT; Gilead Sciences; Arcus Biosciences; STAR-221; gastric cancer; esophageal cancer; zimberelimab; Opdivo (nivolumab); Phase 3 trial failure; overall survival; casdatifan; immuno-oncology; EDGE-Gastric

Enliven Therapeutics Announces New CEO

4 weeks ago talkbio0Tagged CEO, ELVN, Enliven Therapeutics, Leadership, Myeloid Leukemia, Chronic, Phase 3 trial, Richard Fair, Rick Fair, Transition Mutation

Enliven Therapeutics; ELVN; new CEO; Rick Fair; Richard Fair; Sam Kintz; leadership transition; Phase 3 trial; ELVN-001; chronic myeloid leukemia; CML; biotech; Nasdaq ELVN

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

2 months 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

2 months 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 months 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

2 months 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

2 months 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