2025年初展望报告

December 2024 Contents About the Author ............................................................................................................................................ 3Executive Summary ....................................................................................................................................... 3Disclaimer........................................................................................................................................................ 3Outcomes of Biomedtracker’s Large Impact Drug Catalysts from the Q4 2024 Outlook Report ...... 4Drugs................................................................................................................................................................ 6Ovastat for Bone Marrow Transplant and Stem Cell Transplant........................................................................ 6Elamipretide (Systemic Delivery) for Cardiomyopathy - Dilated ........................................................................ 7CHIKV VLP for Chikungunya Virus ......................................................................................................................... 8Ozempic for Diabetic Nephropathy ........................................................................................................................ 9Translarna for Duchenne Muscular Dystrophy (DMD)....................................................................................... 10Tabelecleucel for Hematologic Cancer................................................................................................................ 11Rivoceranib for Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases)........................... 12Datopotamab Deruxtecan for HR+/HER2- Breast Cancer................................................................................. 13MenABCWY (GSK) for Meningococcal Vaccines and Other Meningococcus-Specific Agents(Antibacterial)........................................................................................................................................................... 14AXS-07 for Migraine and Other Headaches........................................................................................................ 15MirdametinibforNeurofibromatosis (NF) ............................................................................................................. 16Suzetrigine for Postsurgical Pain .......................................................................................................................... 17RexultiforPost-Traumatic Stress Disorder (PTSD) ............................................................................................ 18Cardamyst for Supraventricular Tachycardia...................................................................................................... 19AmvuttraforTransthyretin Amyloid Cardiomyopathy (ATTR-CM, Wild Type Or Hereditary) ...................... 20GSK2140944forUrinary Tract and Reproductive Tract Infections (Antibacterial) ........................................ 22Deals...............................................................................................................................................................23AlloVir Acquisition by Kalaris Completed............................................................................................................. 23Biotheus Acquisition by BioNTech Completed ................................................................................................... 23Gynesonics Acquisition by Hologic Completed .................................................................................................. 24Poseida Acquisition by Roche Completed........................................................................................................... 24 About the Author Biomedtrackeris an independent research service that offers proprietary clinical assessments and patient-basedrevenue forecasts of developmental drugs within a comprehensive and intuitive drug information database. Clientsfrom the pharmaceutical, biotech, and investment industries rely on Biomedtracker for its insight on the likelihood ofapproval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape ofevery important disease and indication. Over the last several years, Biomedtracker has become the leader inproviding objective information alongside evidence based clinical assessments and investment research on pipelinedrugs worldwide. For more information on getting direct access to Biomedtracker, please emailBiomedSupport@sagientresearch.com. Executive Summary In this report, we cover catalysts from 20 drugs, devices, diagnostics, and deals expected to occur in Early 2025. Foreach drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given theirparticular phase, drug class, and disease group are provided. T