Alterity Therapeutics receives regulatory feedback from FDA regarding ATH434

Alterity Therapeutics (ATHE) 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.”