- Alterity Therapeutics (NASDAQ:ATHE) is up 71% premarket after receiving FDA guidance on a development pathway for ATH434 (previously PBT434), the company's lead compound for the treatment of Multiple System Atrophy (MSA), a Parkinsonian disorder, including feedback on the design of a Phase 2 trial.
- Alterity reached agreement with the agency on the non-clinical investigations required to support the mid-stage study, along with patient population, safety monitoring plan, and strategy for evaluating drug exposure during the trial.
- The agency and Alterity will work together to develop an endpoint that is best suited for the MSA patients.
- The company is also pursuing approvals in Europe and Australia.