Alterity Therapeutics Ltd ATHE
Alterity Therapeutics Ltd (Nasdaq: ATHE) is a CNS/neurology/psychiatry drug developer. Its lead program, ATH434, is in Phase 2 for Multiple System Atrophy (MSA).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ATH434 | Multiple System Atrophy | small molecule | Phase 2 |
| ATH434 | Parkinson's disease | small molecule | Pre-clinical |
| Next-generation zinc ionophores / discovery library | various (cancer, neurological, infectious disease) | small molecule | Pre-clinical |
Recent results and decisions
- Oct 30, 2026accepted FDA End-of-Phase 2 meeting minutes confirmed Phase 3 trial design and registrational pathway for ATH434 in MSA.
The minutes confirmed that the FDA agreed with the proposed Phase 3 design, including the study population, treatment regimen, and primary endpoint.
Filing - Oct 30, 2026started Alterity has begun Phase 3 operational activities including finalizing protocol and selecting vendors.
Alterity has begun Phase 3 operational activities including finalizing the protocol, selecting vendors, identifying and qualifying clinical trial sites, and successfully manufacturing the first registration batch of ATH434 for use in the pivotal trial.
Filing - Oct 30, 2026submitted FDA End-of-Phase 2 meeting minutes confirmed the Phase 3 trial design and registrational pathway for ATH434 in MSA.
The minutes confirmed that the FDA agreed with the proposed Phase 3 design, including the study population, treatment regimen, and primary endpoint ‒ the 11-item UMSARS Part I rating scale, a functional measure of activities of daily living affected in MSA.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.