Uncategorized – Page 9

Astellas Secures $1.34B Licensing Deal for CLDN18.2-Targeted ADC with Evopoint Biosciences

2 weeks ago talkbio0Tagged Antibody-Drug Conjugates, Astellas, Evopoint Biosciences, Licensing Deal, Neoplasms, therapeutic autologous dendritic cells

Astellas; Evopoint Biosciences; CLDN18.2; antibody-drug conjugate; ADC; licensing deal; oncology; XNW27011

Merck Advances Middle Dose of ROR1 ADC in Relapsed/Refractory DLBCL After Safety Review

2 weeks ago talkbio0Tagged Adverse event, Clinical Trials, Diffuse Large B-Cell Lymphoma, Merck, middle dose, Relapsing course, ROR1 protein, human, Safety, therapeutic autologous dendritic cells, Unresponsive to Treatment, vedotin, waveLINE-003, Zilovertamab

Merck; ROR1; ADC; zilovertamab vedotin; middle dose; 1.75 mg/kg; relapsed DLBCL; refractory DLBCL; WaveLINE-003; safety; adverse events; clinical trial; ASCO 2025

Sanofi, Regeneron’s IL-33 Drug Fails One of Two COPD Studies, Casting Doubt on FDA Approval Timeline

2 weeks ago talkbio0Tagged AERIFY-1, AERIFY-2, Approved, Clinical Trials, COPD, IL33 protein, human, itepekimab, Regeneron, sanofi, United States Food and Drug Administration

Sanofi; Regeneron; COPD; itepekimab; IL-33; Phase 3 trials; AERIFY-1; AERIFY-2; FDA approval; clinical trial results

Keros Therapeutics Halts Pulmonary Hypertension Drug After Safety Issues, Cuts 45% of Workforce

2 weeks ago talkbio0Tagged biotech sector, cibotercept, drug development halt, Financial cost, Financial savings, layoffs, PAH, Pericardial effusion, Pulmonary arterial hypertension

Keros Therapeutics; cibotercept; pulmonary arterial hypertension; PAH; layoffs; pericardial effusion; drug development halt; cost savings; biotech sector

Analysts Downplay Intellia Adverse Event, but Gene Therapy Safety Remains Under Scrutiny

2 weeks ago talkbio0Tagged Adverse event, ATTR-CM, Event, Gene Modification, gene therapy, Intellia, liver transaminase, MAGNITUDE trial, Response process, Safety, Stock Decline

Intellia Therapeutics; gene therapy; safety event; adverse event; MAGNITUDE trial; liver transaminase; stock decline; ATTR-CM; gene editing; analyst response

Trump Administration Cancels Major Federal Funding for Moderna’s Bird Flu Vaccine

2 weeks ago talkbio0Tagged Administration occupational activities, bird flu vaccine, cancellation, CHARGE Syndrome, H5 avian influenza, HHS, Moderna, mRNA Vaccine, pandemic preparedness, Transplant Registry Unified Management Program

Trump administration; Moderna; bird flu vaccine; HHS; funding cancellation; mRNA vaccine; pandemic preparedness; H5 avian influenza

FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval

2 weeks ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, Accelerated, Approved, Elamipretide, Infrequent, muscle strength endpoint, Phase 2 trial, regulatory delay, Rejection, Stealth BioTherapeutics, United States Food and Drug Administration

FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay

Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss

2 weeks ago talkbio0Tagged Application procedure, Clinical Trials, Daiichi, Deruxtecan, HER3, Merck, Non-Small Cell Lung Carcinoma, Overall Survival, patritumab, Sankyo, therapeutic autologous dendritic cells, United States Food and Drug Administration, Withdraw (activity)

Merck; Daiichi Sankyo; patritumab deruxtecan; HER3 ADC; FDA application; non-small cell lung cancer; clinical trial; overall survival; application withdrawal