Clinical-Stage Biopharmaceuticals Report Mixed Q3 Financial, Trial Progress

Several clinical-stage biopharmaceutical companies have recently released their quarterly Form 10-Q reports, highlighting ongoing clinical development and financial performance. Applied Therapeutics is advancing its lead candidate AT-007 for rare diseases such as Classic Galactosemia and CMT-SORD, addressing FDA concerns, and plans to present Phase 3 data in 2025. Rani Therapeutics is focused on oral biologic delivery with its RaniPill technology, demonstrating promising preclinical data and preparing for clinical trials of a higher-capacity capsule in mid-2025. Moleculin Biotech is conducting a pivotal global Phase 3 trial for Annamycin in relapsed/refractory AML, with interim data expected by the end of 2025, and has gained WHO recognition for its drug’s non-proprietary name. Medicus Pharma is progressing in skin cancer treatments with a Phase 3 trial for nodular BCC and expanding study sites, actively engaging with the FDA on trial protocols. These companies continue to invest in research and development despite operating losses, underscoring their commitment to advancing novel therapies in rare and difficult-to-treat diseases.