Biologically Active Substance – Page 3

Genmab Discontinues ProfoundBio-Derived ADC GEN1107 After Acquisition, Paralleling J&J’s Ambrx Buyout Area Developments

1 month ago talkbio0Tagged AbbVie, Acquisition, Ambrx, Antibody-Drug Conjugates, Drug Development, GEN1107, Genmab, J&J, Johnson and Johnson, Neoplasms, ProfoundBio, PTK7, PTK7 protein, human

Genmab; ProfoundBio; antibody-drug conjugate (ADC); GEN1107; PTK7; Ambrx; Johnson & Johnson (J&J); oncology; drug development; biotech acquisition; AbbVie lawsuit

Zealand Pharma Pauses Development of GLP-1/GLP-2 Dual Agonist Dapiglutide for Obesity

1 month ago talkbio0Tagged Agonist, Clinical Development, Dapiglutide, drug market, GLP-1/GLP-2, Obesity, obesity therapy, petrelintide, pipeline management, Zealand Pharma

Zealand Pharma; dapiglutide; GLP-1/GLP-2 dual agonist; obesity therapy; clinical development; obesity drug market; pipeline management; petrelintide; survodutide

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

1 month ago talkbio0Tagged agency instability, Biological Factors, CBER, CDER, Drug Approval, Leadership, Project, regulatory dynamics, Richard Pazdur, United States Food and Drug Administration, Vinay Prasad

Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis

Odyssey Therapeutics Appoints Dennis Dean as EVP, Head of Non-Clinical Development

1 month ago talkbio0Tagged Autoimmune Diseases, Biological Factors, Dennis Dean, Drug Development, executive vice president, Head of Non-Clinical Development, Odyssey Therapeutics, preclinical research

Odyssey Therapeutics; Dennis Dean; Executive Vice President; Head of Non-Clinical Development; preclinical research; autoimmune diseases; drug development; biopharmaceutical

Nkarta Reports Third Quarter 2025 Financial Results and Corporate Highlights

1 month ago talkbio0Tagged Capitalization, clinical-stage biopharma, development aspects, exophthalmos producing substance, financial results, Impaired, Market, net loss, Nkarta, Operating expenses, Q3, research

Nkarta; Q3 2025 financial results; net loss; operating expenses; EPS; research and development; impairment; market capitalization; clinical-stage biopharma; corporate highlights

Amgen’s Repatha Reduces First-Time Cardiovascular Events by 25% in Major Clinical Trial

1 month ago talkbio0Tagged amgen, Cardiovascular event, Cholesterol Drug, Clinical Trials, evolocumab, LDL Cholesterol Lipoproteins, Myocardial Infarction, PCSK9 inhibitor, Primary Prevention, Repatha, VESALIUS-CV

Amgen; Repatha; evolocumab; cholesterol drug; PCSK9 inhibitor; cardiovascular events; clinical trial; VESALIUS-CV; primary prevention; heart attack; LDL cholesterol

Ionis Claims Curative Potential for Tryngolza in Severe Triglyceride Disease

1 month ago talkbio0Tagged Antisense Oligonucleotides, curative potential, Hypertriglyceridemia, Ionis, Pancreatitis, Acute, Phase 3 Clinical Trials, RNA-targeted therapy, Severe (severity modifier), Submission, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis; Tryngolza; severe hypertriglyceridemia; curative potential; triglyceride reduction; acute pancreatitis; antisense oligonucleotide; FDA submission; Phase III trial; RNA-targeted therapy

Eli Lilly Hires Denali Therapeutics Executive Carole Ho to Lead Neuroscience Division

1 month ago talkbio0Tagged Biological Factors, Carole Ho, Changing, Denali, eli lilly, executive leadership, Leadership, neuroscience division

Eli Lilly; Denali Therapeutics; Carole Ho; neuroscience division; executive leadership; biopharmaceuticals; leadership changes

FDA Extends Review Period for Rhythm Pharmaceuticals’ Imcivree (Setmelanotide) in Acquired Hypothalamic Obesity

2 months ago talkbio0Tagged Agonist, amendment, goal, Hypothalamic structure, Imcivree, MC4R protein, human, PDUFA, Phase 3 trial, review extension, Rhythm Pharmaceuticals, setmelanotide, United States Food and Drug Administration

Imcivree; Rhythm Pharmaceuticals; FDA; review extension; acquired hypothalamic obesity; setmelanotide; PDUFA goal date; Phase 3 trial; major amendment; MC4R agonist

Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

2 months ago talkbio0Tagged asparagine, Atacicept, autoimmune kidney disease, Blackfoot language, File (record), IGA, IGA Glomerulonephritis, Kidney, Phase 3 trial, Proteinuria, Submission, United States Food and Drug Administration, UPCR, Vera Therapeutics

Vera Therapeutics; atacicept; Phase 3 trial; IgA nephropathy; proteinuria reduction; UPCR; FDA filing; BLA submission; ASN Kidney Week 2025; autoimmune kidney disease