Alterity Therapeutics (ATHE,ATH.AX) announced that it has received positive regulatory feedback following a Type C Meeting with the U.S. Food and Drug Administration (FDA) regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy (MSA).
The Type C Meeting is part of Alterity's multidisciplinary strategy to align with the FDA on readiness to initiate a pivotal Phase 3 trial in MSA. The company reported that it received written feedback supporting its plans related to both the clinical pharmacology and non-clinical development aspects of the program, reinforcing confidence in moving forward with the next stage of clinical testing.
ATH.AX was trading on the Australian Securities Exchange at A$0.0080, showing no change from the previous session.
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