Alfa – Talk Bio

Marengo’s invikafusp alfa shows promising monotherapy activity in PD-1 resistant gastrointestinal cancers

1 week ago talkbio0Tagged Alfa, Colorectal Carcinoma, fast-track designation, High tumor mutational burden, High-Frequency Microsatellite Instability, Immunotherapy, invikafusp, Malignant neoplasm of gastrointestinal tract, Marengo Therapeutics, PDCD1 gene, resistant tumors, United States Food and Drug Administration

Invikafusp alfa; Marengo Therapeutics; PD-1 resistant tumors; Gastrointestinal cancers; Colorectal cancer; TMB-H; MSI-H; Immunotherapy; ESMO 2025; FDA Fast Track designation

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

2 months ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Bicara’s Ficerafusp Alfa Shows 46% 2-Year Survival Rate for Head and Neck Cancer Subset at ASCO 2025

6 months ago talkbio0Tagged 2025, Alfa, Antibody Therapy, ASCO, Bicara Therapeutics, Cancer of Neck, Head, Keytruda, Overall Survival, PD-L1, tumor shrinkage

ASCO 2025; Bicara Therapeutics; ficerafusp alfa; head and neck cancer; PD-L1; overall survival; antibody therapy; Keytruda; tumor shrinkage

Biohaven’s Taldefgrobep Alfa Shifts Focus to Obesity After Missing Primary Endpoint in Spinal Muscular Atrophy Phase 3 Trial

1 year ago talkbio0Tagged Alfa, Body Composition, Bone and Bones, density, GDF8 protein, human, Inhibitor, lean, Obesity, Phase 3 trial, Spinal Muscular Atrophy

Biohaven, taldefgrobep alfa, spinal muscular atrophy (SMA), obesity, myostatin inhibitor, phase 3 trial, body composition, lean muscle mass, bone density.

Lilly’s Weekly Insulin Candidate Efsitora Alfa Shows Promising Results in Phase III Trials

1 year ago talkbio0Tagged Alfa, Diabetes, Diabetes Mellitus, Non-Insulin-Dependent, efsitora, Eli, Eli Lilly, Insulin, Phase 3 Clinical Trials, QWINT, Weekly

Eli Lilly, Efsitora Alfa, Weekly Insulin, Type 1 Diabetes, Type 2 Diabetes, Phase III Trials, QWINT Studies, Diabetes Treatment

Lilly’s Once-Weekly Insulin Efsitora Alfa Achieves Non-Inferiority in Four Phase 3 Trials

1 year ago talkbio0Tagged Administration occupational activities, Alfa, Diabetes, efsitora, Eli, Eli Lilly, Hemoglobin A1c measurement, Insulin, insulin therapy, non-inferiority, once-weekly, Phase 3 trials

Eli Lilly, efsitora alfa, once-weekly insulin, diabetes management, Phase 3 trials, non-inferiority, A1C reduction, insulin therapy.

Eli Lilly’s Weekly Insulin Efsitora Alfa Shows Promising Results in Late-Stage Trials

1 year ago talkbio0Tagged Administration occupational activities, Alfa, Diabetes, efsitora, Eli, Eli Lilly, Insulin, insulin therapy, Phase 3 Clinical Trials, QWINT-1, QWINT-3, Weekly

Eli Lilly, weekly insulin, efsitora alfa, type 2 diabetes, Phase III trials, QWINT-1, QWINT-3, insulin therapy, diabetes management

BioMarin’s Brineura Receives Significant Label Expansion from FDA for Children Under 3 with CLN2 Disease

1 year ago talkbio0Tagged Alfa, BioMarin, Brineura, cerliponase, Child, Deterioration, expansion, Injection of therapeutic agent, Intraventricular, Labels (device), motor ability, Neurodegenerative, Symptoms aspect, TPP1 gene, United States Food and Drug Administration

BioMarin, Brineura, FDA, Label Expansion, CLN2 Disease, Children Under 3, Cerliponase Alfa, Intraventricular Injection, Motor Ability Deterioration, Neurodegenerative Symptoms