The shares of Alterity Therapeutics Limited (ASX:ATH) on 1 July 2020 skyrocketed on ASX by 1,782.353% (AEST 12:07 PM). On 30 June 2020, the company announced that it received guidance from US FDA related to the development pathway for ATH434, Alterity’s lead compound for the treatment of Multiple System Atrophy.
Post the completion of Phase 1 clinical trial last year and further data analysis, the company recently met with the FDA on the non-clinical investigations required to support the Phase 2 study. Further, the FDA agreed to key aspects of the Company’s Phase 2 study design which includes the proposed patient population, safety monitoring plan, and strategy for evaluating drug exposure during the study.
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