Alterity Therapeutics Limited
ATHE evidence brief
What we can confirm
- Market Cap:
- $73.7M
- Next Catalyst:
- Patent_Expiry · Sep 1, 2040
What it means
What to watch
Prepared research question
What matters most for ATHE—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ATHE
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) is a clinical-stage biotechnology company developing disease-modifying therapies for neurodegenerative diseases, with a lead asset ATH434 targeting Multiple System Atrophy (MSA) and related Parkinsonian disorders [news · published 2026-09-23].
Key risk: Phase 3 trial not yet started
Tracking 2 clinical trials · 1 catalyst for Alterity Therapeutics Limited.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) is a clinical-stage biotechnology company developing disease-modifying therapies for neurodegenerative diseases, with a lead asset ATH434 targeting Multiple System Atrophy (MSA) and related Parkinsonian disorders [news · published 2026-09-23].
- Alterity is preparing to initiate a Phase 3 pivotal trial in Multiple System Atrophy (MSA) [news · published 2026-09-23].
- ATH434 50 mg slowed functional decline in MSA by approximately 52% versus placebo on the 11-item UMSARS at Week 52 [news · published 2026-10-05].
- Cash balance of A$49.2M as of December 31, 2025 [news · published 2026-01-30].
- Alterity secured a US patent for ATH434 extending protection to 2045 [news · published 2026-08-12].
- FDA Fast Track Designation granted for ATH434 to treat MSA [news · published 2025-07-30].
What works
- ATH434 demonstrated a 52% slowing of functional decline in MSA versus placebo in Phase 2, with statistical significance [news · published 2026-10-05].
- The company has a strong cash position of A$49.2M as of December 31, 2025, providing runway for Phase 3 planning [news · published 2026-01-30].
- Positive FDA feedback received following a Type C Meeting, aligning on key elements of the Phase 3 program [news · published 2026-03-30].
- US composition of matter patent for ATH434 extends protection to 2045, enhancing long-term commercial potential [news · published 2026-08-12].
What to weigh
- Alterity is a pre-revenue clinical-stage company with no approved products, relying on cash reserves and future financing [news · published 2026-09-23].
- The Phase 3 trial in MSA has not yet commenced, and regulatory approval is uncertain [news · published 2026-09-23].
- The company faces competition from other neurodegenerative disease therapies and must demonstrate efficacy in a larger pivotal trial [news · published 2026-10-05].
From the filings
Quoted directly from source documents.
ATH434 slowed functional decline by 52% in Phase 2 MSA trial
“ATH434 50 mg significantly slowed functional decline in MSA by approximately 52% versus placebo on the 11-item UMSARS at Week 52 with CSF NfL as a covariate”
News · October 5, 2026
Cash position as of December 31, 2025
“Alterity Therapeutics Reports A$49.2M Cash As Of Dec. 31”
News · January 30, 2026
US patent for ATH434 extends to 2045
“Alterity Therapeutics secured a USPTO patent for ATH434, extending market protection for its neurodegenerative drug candidate to 2045.”
News · August 12, 2026
FDA Fast Track Designation for ATH434 in MSA
“Granted U.S. FDA Fast Track Designation for ATH434 to treat Multiple System Atrophy (MSA)”
News · July 30, 2025
Catalyst timeline
- 2040-09-01 · Patent_Expiry · TRAMADOL HYDROCHLORIDE — Patent expiry for NDA214044 (TRAMADOL HYDROCHLORIDE) is scheduled; this is unrelated to ATH434 but may affect broader portfolio considerations.
Risks & what to watch (3)›
Key risks
- Phase 3 trial not yet started — Alterity has not yet initiated the pivotal Phase 3 trial for ATH434, creating timeline uncertainty [news · published 2026-09-23].
- Pre-revenue status — The company has no approved products and generates no revenue, relying on cash reserves of A$49.2M as of Dec 2025 [news · published 2026-01-30].
- Regulatory approval uncertainty — Positive FDA feedback received but Phase 3 design and endpoints still need final validation [news · published 2026-03-30].
What to watch
- Initiation of the Phase 3 pivotal trial in MSA, expected after FDA End-of-Phase-2 meeting in mid-2026 [news · published 2026-01-30].
- Cash burn rate and any new financing rounds as the company advances toward Phase 3 [news · published 2026-01-30].
- Further clinical data from ATH434 in Parkinson's disease or other neurodegenerative indications [news · published 2026-08-12].
- Patent expiry of TRAMADOL HYDROCHLORIDE on 2040-09-01, though not directly related to ATH434 [upcoming catalysts].
Sources: News · Generated October 12, 2026 · How we verify sources →
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Evidence & data
Catalysts
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
15
Total value held
$1.1M
| Holder | Shares | Value |
|---|---|---|
| twin lakes capital management, llc | 139,258 | $485K |
| hb wealth management, llc | 58,460 | $203K |
| morgan stanley | 58,382 | $203K |
| greenleaf trust | 32,000 | $111K |
| citadel advisors llc | 20,077 | $71K |
| bnp paribas financial markets | 6,809 | $24K |
| rhumbline advisers | 1,970 | $7K |
| gamma investing llc | 1,856 | $6K |
| osaic holdings, inc. | 68 | $240 |
| blue trust, inc. | 40 | $139 |
Showing top 10 of 15 institutional holders of Alterity Therapeutics Limited. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 0.1%
- Days to cover
- 0.6
- Shares short
- 13,895
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ATHE short interestFrequently asked questions
What is the AI investment thesis for Alterity Therapeutics Limited?
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) is a clinical-stage biotechnology company developing disease-modifying therapies for neurodegenerative diseases, with a lead asset ATH434 targeting Multiple System Atrophy (MSA) and related Parkinsonian disorders [news · published 2026-09-23].
What is Alterity Therapeutics Limited's next catalyst?
Alterity Therapeutics Limited's next tracked catalyst is a Patent_Expiry event — "Patent_Expiry: NDA214044" — expected September 1, 2040.
Who is the CEO of Alterity Therapeutics Limited?
Dr. David A. Stamler M.D. is the chief executive officer of Alterity Therapeutics Limited (ATHE).
Where is Alterity Therapeutics Limited headquartered?
Alterity Therapeutics Limited (ATHE) is headquartered in Melbourne, VIC, Australia.
What therapeutic areas does Alterity Therapeutics Limited focus on?
Alterity Therapeutics Limited develops therapies across Pain, Psychiatry.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.