医疗器械跟踪器生物材料Q4 2025

October 2025 Contents About the Author ............................................................................................................................................ 3Executive Summary ....................................................................................................................................... 3Disclaimer........................................................................................................................................................ 3Outcomes of Biomedtracker’s Large Impact Drug Catalysts from the Q3 2025 Outlook Report ...... 4Drugs................................................................................................................................................................ 6PDUFA Approval........................................................................................................................................................ 6TransCon CNP for Achondroplasia ....................................................................................................................................... 6Ziftomenib for Acute Myelogenous Leukemia (AML) ......................................................................................................... 7Depemokimab for Asthma...................................................................................................................................................... 8Cardamyst for Supraventricular Tachycardia ...................................................................................................................... 9Aficamten for Cardiomyopathy - Hypertrophic..................................................................................................................10Relacorilant for Cushing's Syndrome..................................................................................................................................11Reproxalap for Dry Eye (Ophthalmology) ..........................................................................................................................12Lerochol for Dyslipidemia / Hypercholesterolemia ...........................................................................................................13plozasiran for Familial Chylomicronemia Syndrome (FCS)/Lipoprotein Lipase Deficiency (LPLD)...........................14sibeprenlimab for Immunoglobulin A (IgA) Nephropathy (Berger's Disease) ...............................................................15Gazyva for Lupus Nephritis ..................................................................................................................................................16ND0612 for Parkinson's Disease (PD) ................................................................................................................................17Zoliflodacin for Urinary Tract and Reproductive Tract Infections (Antibacterial)..........................................................18Data Readout............................................................................................................................................................ 19VLA15 for Antibacterial and Antifungal - Miscellaneous Vaccines and Treatments.....................................................19Kerendia for Chronic Kidney Disease (CKD) .....................................................................................................................20mRNA-1647 for Cytomegalovirus (CMV) Infection (Antiviral) .........................................................................................21LatozinemabforFrontotemporal Dementia (FTD).............................................................................................................22Ziihera for Gastric Cancer ....................................................................................................................................................23Lynkuet for Menopause (including Hormone Replacement Therapy [HRT]) ................................................................25SAR442168 for Multiple Sclerosis (MS) .............................................................................................................................26CagriSema for Obesity ..........................................................................................................................................................27Fasedienol for Social Anxiety Disorder (SAD) ...................................................................................................................28 BioNTech Acquisition of CureVac Completed...................................................................................................................30Kite Pharma Acquisition of Interius Completed .................................................................................................................30Sanofi Acquisition of Vicebio Completed ............................................................................