ATHE News & Events

Alterity Therapeutics announced it has received regulatory feedback following a Type C Meeting with the FDA regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy. The Type C Meeting is part of a multidisciplinary strategy to seek alignment with the FDA on readiness to initiate a Phase 3 pivotal trial in MSA. Alterity received written feedback supporting its plans related to the clinical pharmacology and non-clinical development elements of the program. "This meeting confirms alignment with the FDA in two key disciplines and represents an important step toward initiation of the Phase 3 program," said David Stamler, CEO of Alterity. "In addition, we will also be seeking agreement with the FDA on Chemistry, Manufacturing, and Controls and the Phase 3 trial design. Today's favorable outcome sets the stage for our future discussions, culminating in an End-of-Phase 2 meeting that remains on track for mid-year 2026."

Alterity Therapeutics announced that Daniel Claassen, M.D., M.S., was appointed Chief Medical Advisor and will begin his role in March 2026. As a tenured professor, Dr. Claassen will also retain his academic appointment at Vanderbilt University Medical Center. Claassen is a board-certified neurologist and internationally recognized expert in neurodegenerative diseases, with more than two decades of clinical and translational research in movement disorders and cognitive and behavioral neurology. He has authored hundreds of peer-reviewed publications and secured sustained competitive grant funding from agencies including the National Institutes of Health, the U.S. Department of Defense, and numerous foundations.

Alterity Therapeutics released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 December 2025. Key highlights: Phase 2 data for ATH434 in Multiple System Atrophy strengthened by additional analyses and multiple international scientific presentations during the quarter. Regulatory planning activities advancing toward a Phase 3 program, including preparation for FDA End-Of-Phase-2 meeting in mid-2026. Ongoing partnering and strategic discussions with pharmaceutical companies and corporate advisers to explore non-dilutive pathways to fund Phase 3 development. Board and executive leadership strengthened to support Alterity through its next stage of clinical development, partnering and commercial planning. Cash balance of A$49.2 million at 31 December 2025.