Welcome to our dedicated page for Alterity Therapeutics news (Ticker: ATHE), a resource for investors and traders seeking the latest updates and insights on Alterity Therapeutics stock.
News and updates for Alterity Therapeutics Limited (ATHE) center on its progress as a clinical stage biotechnology company developing disease modifying treatments for neurodegenerative diseases. The company’s announcements emphasize its initial focus on Parkinson’s disease and related disorders, particularly Multiple System Atrophy (MSA), and the development of its lead oral agent ATH434.
Investors and followers of ATHE can expect regular news about clinical trial milestones and data presentations. Alterity has reported positive results from its ATH434‑201 randomized, double‑blind, placebo‑controlled Phase 2 trial in MSA, as well as topline data from the ATH434‑202 open‑label Phase 2 trial in more advanced MSA. Company news often highlights analyses of UMSARS Part I activities of daily living scores, orthostatic hypotension symptom assessments, wearable sensor data, and neuroimaging and biomarker endpoints such as brain iron and the MSA Atrophy Index.
Alterity’s news flow also includes regulatory and designation updates, such as Fast Track Designation by the U.S. Food and Drug Administration and Orphan Drug Designation by the FDA and European Commission for ATH434 in MSA. Additional items cover participation in major neurology and movement disorder conferences, where the company presents new analyses, biomarker findings, and natural history study results, as well as appearances at healthcare and biotech investor events.
On this page, readers can follow announcements about capital raises, quarterly cash flow reports, and corporate presentations that describe Alterity’s cash position, development plans, and engagement with regulators. For those tracking ATHE, the news stream provides context on how the company is advancing ATH434 in MSA, refining its biomarker strategy, and interacting with the scientific and investment communities over time.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) reported Q2 FY26 results and a corporate update for the quarter ended 31 December 2025. Key highlights: strengthened Phase 2 ATH434 data in Multiple System Atrophy (MSA), Fast Track designation from the FDA, ongoing Phase 3 planning and an expected FDA End‑of‑Phase‑2 meeting in mid‑2026. Cash and equivalents were A$49.2 million with operating cash outflows of A$5.28 million for the quarter.
The company continues scientific presentations, advisory engagement and partnering discussions while bolstering board and executive leadership to support late‑stage development.
Alterity Therapeutics (NASDAQ: ATHE) reported that its Phase 2 program of ATH434 in multiple system atrophy (MSA) produced "resoundingly favourable" results, showing safety comparable to placebo with no drug-related serious or severe adverse events and signals of slowed disease progression across functional, mobility, and orthostatic hypotension measures. The company plans an End-of-Phase 2 meeting with the FDA in mid-2026 to finalise Phase 3 design and is scaling clinical, manufacturing, and regulatory resources. Other 2025 actions include appointing Julian Babarczy as Board Chair and strengthening investor relations and corporate strategy teams. Management cites an estimated $2.4 billion market opportunity for MSA.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) announced that CEO David Stamler, M.D. will deliver a corporate update at the Bell Potter Healthcare Virtual Conference.
US presentation: Tuesday, 18 November 2025 at 6:30 p.m. PT / 9:30 p.m. ET. Australia presentation: Wednesday, 19 November 2025 at 1:30 p.m. AEDT (Sydney/Melbourne). Current and interested shareholders can register to view the webcast via the conference registration link.
Alterity Therapeutics (NASDAQ: ATHE) presented analyses from the ATH434-201 Phase 2 MSA trial at the 36th International Symposium on the Autonomic Nervous System on Nov 10, 2025.
Key findings: baseline severe orthostatic hypotension (OH) was higher in the 75 mg arm (29.2%) versus 50 mg (4%) and placebo (4.5%). When orthostatic blood pressure change was included as a covariate, the 75 mg efficacy signal on UMSARS I1 at 52 weeks strengthened from -2.4 to -2.8 points, moving the relative treatment effect from 30% to 35%. Patient‑reported OH symptoms worsened ~6 points on placebo over 52 weeks while both ATH434 dose groups were stable. The company said these insights will guide Phase 3 design and upcoming FDA interactions.
Alterity Therapeutics (NASDAQ: ATHE) released its Q1 FY26 Appendix 4C and program update for the quarter ended 30 September 2025. Key items: cash A$54.56M and operating cash outflows of A$5.34M for the quarter; A$20M gross raised via a strategic placement.
Clinical highlights include a strengthened efficacy signal for ATH434 75 mg (−2.8 UMSARS I points; 35% relative effect at 52 weeks), positive open‑label ATH434‑202 results with brain volume preservation, biomarker target engagement, and peer‑reviewed neuroimaging publication. An independent commercial assessment estimates a USD $2.4B peak sales opportunity in MSA. FDA Type C meetings and an End‑of‑Phase 2 meeting are planned, with the EOP2 expected mid‑2026.
Alterity Therapeutics (NASDAQ: ATHE) presented Phase 2 ATH434-201 data at the 2025 MDS Congress on Oct 9, 2025 showing clinical and biomarker signals in multiple system atrophy (MSA).
Key findings: a 48% relative treatment effect vs placebo on modified UMSARS I at 50 mg (p=0.02), a 30% effect at 75 mg that strengthened to 35% after adjusting for baseline orthostatic hypotension (OH) imbalance, stabilization of OH symptoms versus ~6-point worsening on placebo, neuroimaging evidence of reduced iron in globus pallidus and other regions, and no serious or severe adverse events attributed to ATH434.
Alterity Therapeutics (NASDAQ: ATHE) announced multiple presentations of data from their ATH434-201 Phase 2 clinical trial in Multiple System Atrophy (MSA) at the upcoming 2025 International Congress of Parkinson's Disease and Movement Disorders in Honolulu.
The presentations include an oral platform presentation by CEO David Stamler on how ATH434 slowed disease progression in MSA, and two poster presentations focusing on alpha-synuclein aggregation profiles and clinical/imaging phenotypes. The congress will take place from October 5-9, 2025.
The company aims to educate movement disorder experts about ATH434's potential as a first-ever treatment for MSA.Alterity Therapeutics (NASDAQ: ATHE) presented promising Phase 2 clinical trial data for ATH434 in Multiple System Atrophy (MSA) at the American Neurological Association Annual Meeting. The study demonstrated that both 50mg and 75mg doses of ATH434 effectively modified disease progression and showed target engagement by reducing iron accumulation in MSA-affected brain regions.
The double-blind trial revealed clinically meaningful efficacy, including reduced disease severity on the MSA activities of daily living scale, improvements in core symptoms, and maintained function in outpatient settings. Importantly, ATH434 was well-tolerated with adverse event rates similar to placebo, and no serious adverse events were attributed to the study drug.
Alterity Therapeutics (NASDAQ: ATHE) has secured binding commitments for a A$20.0 million capital raise through a placement of fully paid ordinary shares to international and Australian professional investors. The placement was conducted at A$0.012 per share, representing a 7.7% discount to the last ASX closing price.
The funding follows positive Phase 2 clinical trial results for ATH434 in Multiple System Atrophy (MSA), which demonstrated clinically meaningful benefits and a favorable safety profile. The proceeds will support non-clinical studies, CMC activities, clinical and regulatory activities for ATH434's development in MSA, and general working capital. The company plans to engage with the FDA to discuss the path forward for ATH434's development.
Alterity Therapeutics (NASDAQ: ATHE), a biotechnology company focused on neurodegenerative disease treatments, announced its CEO David Stamler will present a corporate update at the Biotech Showcase event hosted by Peak Asset Management and Monsoon Communications.
The presentation is scheduled for September 3, 2025, at 12:35 PM AEST (September 2, 2025, at 10:35 PM ET). Interested parties can access the presentation through a Zoom webcast by registering online.