Clinical Trials – Page 2

Patient with Preexisting Immunity to AAV Vectors Granted Gene Therapy After Antibody-Depleting Agent Allowed Eligibility

2 weeks ago talkbio0Tagged AAV antibodies, antibody-chopping drug, Clinical Trials, Eligibility Determination, gene therapy

gene therapy; AAV antibodies; ineligible; antibody-chopping drug; clinical trial; eligibility

Ascenta Capital Closes $325 Million Inaugural Fund to Back Exceptional Development-Stage Biotechs

2 weeks ago talkbio0Tagged Ascenta Capital, biotechs, Clinical Trials, Early-stage, Evan Rachlin, Funds, Investments, multi-medicine platforms, portfolio companies, venture capital

Ascenta Capital; biotech investment; venture capital; $325M fund; clinical trials; multi-medicine platforms; Evan Rachlin; Lorence Kim; early-stage biotechs; portfolio companies

Zenas BioPharma Inks $2 Billion+ Licensing Deal With InnoCare for Autoimmune Drug Candidates

2 weeks ago talkbio0Tagged Autoimmune Diseases, BTK inhibitor, Clinical Trials, Inhibitor, InnoCare, Interleukin-17, Multiple Sclerosis, orelabrtuinib, Pharma, TYK2 gene, Zenas BioPharma

Zenas BioPharma; InnoCare Pharma; autoimmune diseases; multiple sclerosis; BTK inhibitor; orelabrtuinib; licensing deal; clinical trials; IL-17 inhibitor; TYK2 inhibitor

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

3 weeks 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

Recent Advances Shifting Perspectives in Cell Therapy (2025)

3 weeks ago talkbio0Tagged CAR T-cell, Cell Therapy, Clinical Trials, controllable, CRISPR therapies, immune cells, Labels (device), Mesenchymal Stem Cells, patient-specific therapy, Solid Neoplasm, United States Food and Drug Administration, Updates

cell therapy; CAR T-cell; solid tumors; FDA label updates; mesenchymal stem cells; CRISPR therapies; patient-specific therapy; ultrasound controllable immune cells; clinical trials

Meeting on the Mesa 2025 Arrives Amid Mixed Signals for Cell and Gene Therapy Sector

3 weeks ago talkbio0Tagged Advanced therapies, Alternative, Cells, Clinical Trials, commercialization, Gene Modification, gene therapy, Industry, meeting, MESA, partnerships, payment, Phoenix Arizona, regulatory challenges, RNA, Messenger, Study models

Cell and gene therapy; Meeting on the Mesa; Commercialization; Clinical trials; Advanced therapies; Industry partnerships; Regulatory challenges; Phoenix Arizona; mRNA; Gene editing; Alternative payment models

Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress

3 weeks ago talkbio0Tagged Clinical Trials, collaborative framework, Drug Approval, Employment Termination, Hetlioz, jet lag disorder, lawsuit, Motion Sickness, sNDA, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness

IO Biotech Sheds 50% of Staff After FDA Blocks Cancer Vaccine Approval Path

3 weeks ago talkbio0Tagged biotech, Cancer Vaccines, Clinical Trials, Cylembio, Financial cost, Io satellite, layoffs, melanoma, Regulatory Setback, Rejection, United States Food and Drug Administration

IO Biotech; layoffs; cancer vaccine; FDA rejection; Cylembio; Phase 3 trial; melanoma; regulatory setback; cost cutting; clinical trial

Enanta Presses Ahead with RSV Drug Zelicapavir Despite Missing Primary Endpoint in Phase IIb Trial

3 weeks ago talkbio0Tagged Clinical Trials, Congestive heart failure, COPD, development aspects, Elderly (population group), Enanta, Hospitalization, Neoplasm Metastasis, Phase II B Trial, primary endpoint, rates, Respiratory syncytial virus, United States Food and Drug Administration, Zelicapavir

Enanta Pharmaceuticals; RSV; zelicapavir; Phase IIb trial; primary endpoint miss; secondary endpoints; clinical trials; FDA Fast Track; elderly; COPD; congestive heart failure; hospitalization rates; future development

MoonLake shares crash after mixed results in pivotal hidradenitis suppurativa studies

4 weeks ago talkbio0Tagged Bimzelx, Clinical Trials, Cosentyx, drug approval outlook, drug market, Hidradenitis Suppurativa, inhibitors, Interleukin-17, MoonLake Immunotherapeutics, Placebos, Response process, sonelokimab

MoonLake Immunotherapeutics; Sonelokimab; hidradenitis suppurativa; Phase 3 trial; clinical trial results; biotech shares; placebo response; drug approval outlook; IL-17 inhibitors; Bimzelx; Cosentyx; drug market potential