Clinical Trials – Page 3

J&J CAR-T Therapy Achieves 100% Response Rate in Early-Stage Lymphoma Trial

4 weeks ago talkbio0Tagged CAR-T therapy, CD19 Antigens, CD20 Antigens, Clinical Trials, dual-targeting, Early-stage, Frequency of Responses, J&J, JNJ-4496, Lymphoma, Phase 1b, relapsed/refractory large-B-cell lymphoma

J&J; CAR-T therapy; lymphoma; early-stage; clinical trial; dual-targeting; CD19; CD20; objective response rate; Phase 1b; JNJ-4496; relapsed/refractory large B-cell lymphoma

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

4 weeks 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

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

4 weeks ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

Insmed’s ‘Unprecedented’ Phase 2 PAH Results Propel Stock and Next-Phase Plans

4 weeks ago talkbio0Tagged Clinical Trials, Insmed, PAH, Phase 3 trial, Pulmonary arterial hypertension, surge, TPTE2 gene, treprostinil palmitil inhalation powder

Insmed; PAH; TPIP; Phase 2b; clinical trial; treprostinil palmitil inhalation powder; stock surge; pulmonary arterial hypertension; Phase 3 trial; biotech

FDA Places Clinical Hold on Five Gilead HIV Studies Due to Safety Concerns

4 weeks ago talkbio0Tagged Biktarvy, CD4 + T-cell, Clinical Trials, Gilead Sciences, GS-1720, GS-4182, HIV, Lenacapavir, Lymphocyte Count measurement, safety signal, Study on Hold, United States Food and Drug Administration

FDA; Gilead Sciences; HIV; clinical hold; GS-1720; GS-4182; clinical trials; safety signal; CD4+ T-cell; lymphocyte count; Biktarvy; lenacapavir

Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results

4 weeks ago talkbio0Tagged Clinical Trials, Engaged to be married, Insmed, PAH, Phase 3 Clinical Trials, Pulmonary arterial hypertension, TPTE2 gene, treprostinil palmitil inhalation powder, United States Food and Drug Administration

Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement

Axsome Plots New Fibromyalgia Trial After FDA Refuses Review of Former Pfizer Candidate

4 weeks ago talkbio0Tagged Analgesics, AXS-14, Axsome, Clinical Trials, esreboxetine, Fibromyalgia, File (record), Pfizer, refusal, trial design, United States Food and Drug Administration

Axsome Therapeutics; esreboxetine; fibromyalgia; FDA; refusal to file; clinical trial; Pfizer; AXS-14; trial design; pain medicine

Metsera Reports Once-Monthly Amylin Analogue Matches GLP-1 Efficacy in Early Phase 1 Results

4 weeks ago talkbio0Tagged Amylin, Clinical Trials, Glucagon-Like Peptide 1, MET-233i, Metsera, Obesity, once-monthly, Phase 1 (qualifier value), Weight-Loss

Metsera; MET-233i; amylin; obesity; weight-loss; GLP-1; once-monthly; clinical trial; phase 1

Regenxbio Reports Consistent One-Year Benefit for DMD Gene Therapy RGX-202

1 month ago talkbio0Tagged AFFINITY DUCHENNE trial, Biological Markers, Clinical Trials, Functional, gene therapy, Muscular Dystrophy, Duchenne, Phase III, Regenxbio, SLC6A8 Inhibitor RGX-202

Regenxbio; DMD; Duchenne muscular dystrophy; RGX-202; gene therapy; AFFINITY DUCHENNE trial; clinical trial; microdystrophin; biomarker; phase I/II; functional data

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

1 month 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