Alterity shares jump 12.97% intraday after receiving positive FDA feedback on ATH434 Phase 3 program.

Alterity Therapeutics surged 12.97% intraday following positive feedback from the FDA after a Type C meeting regarding its Phase 3 development program for ATH434 in Multiple System Atrophy. The FDA aligned with key elements of the program, including clinical pharmacology and non-clinical development, setting the stage for future discussions on trial design and CMC. This regulatory validation represents a significant step forward for Alterity as it progresses toward initiating a pivotal Phase 3 trial. The company remains on track for an End-of-Phase 2 meeting by mid-2026. The positive feedback reinforces investor confidence in the potential of ATH434 to become a disease-modifying treatment for this rare and progressive neurodegenerative condition.