Alterity Therapeutics granted U.S. FDA Fast Track designation for ATH434

Alterity Therapeutics (ATHE) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation for ATH434 for the treatment of Multiple System Atrophy, MSA. This designation is intended to accelerate the development and review of novel investigational products such as ATH434 and recognizes its potential as an innovative approach to address the high unmet need for treating MSA, a disease with no approved therapy. “Receiving the FDA’s Fast Track Designation for ATH434, alongside the Orphan Drug Designation we have already received, underscores the promise of this novel agent to address the urgent need for a disease modifying therapy for individuals with MSA,” said, David Stamler, M.D., Chief Executive Officer of Alterity. “This designation reinforces the potential of ATH434 as demonstrated by recent scientific findings related to its mechanism of action and the robust and clinically meaningful efficacy from our double-blind Phase 2 clinical trial. Importantly, the Fast Track designation provides us the opportunity to interact with the FDA more frequently on the advancement of ATH434, potentially accelerating its development path and approval. We look forward to leveraging the Fast Track designation to bring this promising treatment to patients as quickly as possible.”