ORDINAL – Talk Bio

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

11 hours 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 weeks 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

3 weeks 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

4 weeks 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

2 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

3 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

3 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

4 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

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

4 months ago talkbio0Tagged B-cell depletion, BAFF‑R, cellular targeting, ESSDAI, ianalumab, NEPTUNUS-1, NEPTUNUS-2, Novartis, Phase 3, regulatory filings, safety profile, Sjögren 's disease

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

5 months ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy