医疗器械跟踪器生物材料Q4 2025

Brought to you by: Q4 2025 Outlook Report October 2025 2 October 2025 Copyright © 2025 Evaluate, a Norstella company (Unauthorized photocopying prohibited) Contents About the Author ............................................................................................................................................ 3 Executive Summary ....................................................................................................................................... 3 Disclaimer ........................................................................................................................................................ 3 Outcomes of Biomedtracker’s Large Impact Drug Catalysts from the Q3 2025 Outlook Report ...... 4 Drugs ................................................................................................................................................................ 6 PDUFA Approval ........................................................................................................................................................ 6 TransCon CNP for Achondroplasia ....................................................................................................................................... 6 Ziftomenib for Acute Myelogenous Leukemia (AML) ......................................................................................................... 7 Depemokimab for Asthma ...................................................................................................................................................... 8 Cardamyst for Supraventricular Tachycardia ...................................................................................................................... 9 Aficamten for Cardiomyopathy - Hypertrophic .................................................................................................................. 10 Relacorilant for Cushing's Syndrome .................................................................................................................................. 11 Reproxalap for Dry Eye (Ophthalmology) .......................................................................................................................... 12 Lerochol for Dyslipidemia / Hypercholesterolemia ........................................................................................................... 13 plozasiran for Familial Chylomicronemia Syndrome (FCS)/Lipoprotein Lipase Deficiency (LPLD) ........................... 14 sibeprenlimab for Immunoglobulin A (IgA) Nephropathy (Berger's Disease) ............................................................... 15 Gazyva for Lupus Nephritis .................................................................................................................................................. 16 ND0612 for Parkinson's Disease (PD) ...........................................................................................................