ORDINAL – Talk Bio

Bayer Receives Breakthrough Therapy Designation in US and China for Sevabertinib in First-Line HER2-Mutant NSCLC

3 weeks ago talkbio0Tagged Bayer, Breakthrough Therapy Designation, CDE, China, First line treatment, HER2-mutant, Non-Small Cell Lung Carcinoma, sevabertinib, United States Food and Drug Administration

Bayer; sevabertinib; Breakthrough Therapy Designation; HER2-mutant NSCLC; FDA; China CDE; first-line treatment

Updated Efficacy Data of Ivonescimab Plus Chemotherapy as First-Line Treatment for TNBC at ESMO IO 2025

1 month ago talkbio0Tagged AK112 - 308, Breakthrough Therapy Designation, Combined, Complex partial seizures, disease control rate, ESMO IO, First line treatment, Frequency of Responses, HARMONi-BC1, Ivonescimab, PD-1/VEGF bispecific antibody, PD-L1, Pharmacotherapy, Phase 2 Clinical Trials, Progression-Free Survival, safety profile, Subgroup A Nepoviruses, TNBC, Triple Negative Breast Neoplasms, Yidafan

ivonescimab; Yidafan; PD-1/VEGF bispecific antibody; triple-negative breast cancer; TNBC; first-line treatment; ESMO IO 2025; Phase II trial; chemotherapy combination; objective response rate; progression-free survival; disease control rate; PD-L1 CPS subgroups; safety profile; Breakthrough Therapy Designation; HARMONi-BC1; AK112-308

Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited

2 months ago talkbio0Tagged Bruin-CLL-314, BTK inhibitor, ceiling, Chronic Lymphocytic Leukemia, CLL, eli lilly, expansion, First line treatment, ibrutinib, Imbruvica, Jaypirca, Labels (device), Market, oncology strategy, Pirtobrutinib, Progression-Free Survival, second-line treatment, SLL, traditional approval, United States Food and Drug Administration

Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy

BostonGene to Showcase Transformative Impact of AI-Driven Profiling with Six Abstracts at the 67th American Society of Hematology Annual Meeting & Exposition

2 months ago talkbio0Tagged 67th, AI-driven, annual, Asymmetric Septal Hypertrophy, Biological Markers, BostonGene, Clinical Trials, Hematology (discipline), immune profiling, meeting, Molecular Profiling, Multiple Myeloma, Neoplasms, Precision - temporal, Stratification

BostonGene; AI-driven molecular profiling; hematology; 67th ASH Annual Meeting; immune profiling; multiple myeloma; patient stratification; clinical trials; biomarkers; precision oncology

Roche Bags EU Nod for SC Formulation of Lunsumio, Re-Igniting Bispecific Battle with Tepkinly

2 months ago talkbio0Tagged Antibodies, Bispecific, Approved, Clinical Research, Conditional, EU, GO29781, Lunsumio, Lymphoma, Follicular, marketing authorisation, Relapsed/Refractory, Roche (company), subcutaneous, Tepkinly

Roche; Lunsumio; subcutaneous; EU approval; conditional marketing authorisation; follicular lymphoma; bispecific antibody; Tepkinly; CD20xCD3; relapsed/refractory; GO29781 study

Cogent Hits Unprecedented Efficacy in Rare Stomach Cancer, Clearing Path to FDA

2 months ago talkbio0Tagged bezuclastinib, Cogent Biosciences, Effectiveness, Frequency of Responses, Gastrointestinal Stromal Tumors, Infrequent, Malignant neoplasm of stomach, Progression-Free Survival, second-line treatment, Submission, United States Food and Drug Administration

Cogent Biosciences; bezuclastinib; unprecedented efficacy; rare stomach cancer; gastrointestinal stromal tumor (GIST); FDA submission; second-line treatment; objective response rate; progression-free survival

Boehringer Ingelheim Breaks Decade-Long Drought with FDA Approval of Jascayd for Idiopathic Pulmonary Fibrosis

4 months ago talkbio0Tagged Approved, Boehringer Ingelheim, Chronic lung disease, Idiopathic Pulmonary Fibrosis, Jascayd, lung scarring, nerandomilast, Pulmonary Fibrosis, United States Food and Drug Administration

Boehringer Ingelheim; Jascayd; nerandomilast; FDA approval; idiopathic pulmonary fibrosis; IPF; lung scarring; first new treatment; chronic lung disease

Eli Lilly Touts ‘Striking’ Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study

5 months ago talkbio0Tagged BRUIN, BTK inhibitor, Chronic Lymphocytic Leukemia, Clinical Trials, CLL, CLL-313, eli lilly, expansion, First line treatment, Jaypirca, Labels (device), Progression-Free Survival

Jaypirca; Eli Lilly; CLL; chronic lymphocytic leukemia; BRUIN CLL-313; progression-free survival; BTK inhibitor; first-line treatment; clinical trial; label expansion

Takeda’s Phase 3 Success Positions Oveporexton (TAK-861) as Potential First Mover in Multibillion-Dollar Narcolepsy Market

5 months ago talkbio0Tagged Clinical Trials, multibillion-dollar market, Narcolepsy type 1, oveporexton, Phase 3, Standard of Care, TAK-861, Takeda, TPRG1L gene

Takeda; Phase 3; narcolepsy type 1; oveporexton; TAK-861; orexin agonist; multibillion-dollar market; clinical trial results; first mover; standard of care

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

5 months ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, neutrophil-mediated disease, non-cystic fibrosis bronchiectasis, Progressive, United States Food and Drug Administration

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class