Core Insights - Arcus Biosciences Inc. announced new monotherapy data for casdatifan in late-line metastatic clear cell renal cell carcinoma (ccRCC) [1] - The drug trials are part of a Phase 1/1b study with four cohorts, showing promising results in terms of overall response rate and progression-free survival [1][2] Efficacy Data - In the 100mg tablet cohort, casdatifan demonstrated a 35% confirmed overall response rate (ORR) with median progression-free survival (mPFS) not yet reached after one year of follow-up [2] - Pooled data from 121 patients indicated a confirmed ORR of 31% and a median PFS of 12.2 months, which is significantly longer than existing treatments [3] Safety Profile - At the data cut-off on August 15, 2025, 81% of patients experienced disease control, with 74% of confirmed responders remaining on treatment [4] - No unexpected safety signals were reported, and the safety profile of casdatifan was deemed acceptable and manageable across all doses [4][5] Market Reaction - Following the announcement, Arcus Biosciences shares rose by 7.87% to $14.40, trading within a 52-week range of $6.50 to $18.98 [5]

Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing optimized, novel biologics for immunology and inflammation (I&I) markets, including treatments for Atopic Dermatitis (AD), asthma, Eosinophilic Esophagitis (EoE), and Chronic Obstructive Pulmonary Disease (COPD) [2] - The company aims to create best-in-class therapies by targeting established mechanisms of action and utilizing advanced antibody engineering to enhance properties such as half-life [2] - APG777 is the most advanced program, targeting AD, which is identified as the largest and least penetrated market within I&I [2] Pipeline and Strategy - Apogee has four validated targets in its portfolio and is pursuing both monotherapies and combinations of its novel antibodies to achieve best-in-class profiles [2] - The company believes its broad pipeline and expertise can provide significant value and benefits to patients who are underserved by current standard care [2] Upcoming Events - Management will participate in a fireside chat at the Stifel 2025 Virtual Immunology and Inflammation Forum on September 16, 2025, at 11:30 a.m. E.T., with a live and archived webcast available on the company's website [1]