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Zhongmou Therapeutics Reports First-in-Human Success of Optogenetic Gene Therapy ZM-02 for Retinitis Pigmentosa

2 days ago talkbio0Tagged AAV Vector, First-in-Human Clinical Trial, gene therapy, Ophthalmology specialty, Optogenetic Gene Therapy, PsCatCh2.0, Retinitis Pigmentosa, Vision Restoration, Zhongmou, ZM-02

Zhongmou Therapeutics; Optogenetic Gene Therapy; ZM-02; Retinitis Pigmentosa; First-in-Human Clinical Trial; Vision Restoration; AAV Vector; PsCatCh2.0; Gene Therapy; Ophthalmology

Vera Therapeutics Appoints James R. Meyers to Its Board of Directors

3 days ago talkbio0Tagged Appointments, Atacicept, Autoimmune Diseases, Biological Factors, biotech executive, board of directors, Gilead Sciences, IGA Glomerulonephritis, IntraBio Ltd., James, Vera Therapeutics

Vera Therapeutics; James R. Meyers; Board of Directors; appointment; biotech executive; IgA nephropathy; atacicept; autoimmune diseases; Gilead Sciences; IntraBio Ltd; biopharmaceutical

Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management

3 days ago talkbio0Tagged Chinese Language, Clinical Research, Gan & Lee Pharmaceuticals, Glucagon-Like Peptide 1, GRADUAL-3, innovation, once-monthly, Phase 3, Rheumatoid Arthritis, Weight maintenance regimen

Gan & Lee Pharmaceuticals; Phase 3 clinical study; GRADUAL-3; once-monthly GLP-1 RA; weight management; Chinese innovation

Otsuka’s Anti-APRIL Antibody (Voyxact/Sibeprenlimab) Receives FDA Approval for IgA Nephropathy (IgAN)

4 days ago talkbio0Tagged anti-APRIL antibody, Approved, IGA Glomerulonephritis, Monoclonal Antibodies, Otsuka, Proteinuria, Sibeprenlimab, United States Food and Drug Administration, Voyxact

Otsuka; anti-APRIL antibody; Voyxact; sibeprenlimab; FDA approval; IgA nephropathy; IgAN; proteinuria; monoclonal antibody

FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months

4 days ago talkbio0Tagged Achondroplasia, Approved, Ascendis Pharma, CNP gene, Deferred, Dwarfism, navepegritide, PDUFA, post-marketing requirement, TransCon, United States Food and Drug Administration

FDA; Ascendis Pharma; TransCon CNP; navepegritide; achondroplasia; dwarfism; PDUFA; post-marketing requirement; delay; approval

Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny

4 days ago talkbio0Tagged Approved, BiomX, Clinical, Imfinzi, Malignant neoplasm of cardioesophageal junction of stomach, Malignant neoplasm of stomach, Nebulizers, perioperative, United States Food and Drug Administration

Imfinzi; FDA approval; gastric cancer; gastroesophageal cancer; perioperative; BiomX; nebulizer; clinical hold

BridgeBio Oncology Therapeutics: Recent News Overview (November 2025)

4 days ago talkbio0Tagged AACR-NCI-EORTC, BridgeBio Oncology Therapeutics, clinical-stage biopharma, de-SPAC transaction, financial results, financing characteristics, Helix Acquisition Corp II, PI3Kδ, Piperine Extract (Standardized), ras Oncogene, third quarter 2025

BridgeBio Oncology Therapeutics; Helix Acquisition Corp II; de-SPAC transaction; PIPE financing; RAS and PI3Kα; clinical-stage biopharma; AACR-NCI-EORTC Conference; third quarter 2025 financial results