Alterity Therapeutics (ATHE) Stock News

Alterity Therapeutics (NASDAQ: ATHE) appointed Daniel O. Claassen, M.D., M.S., as Chief Medical Advisor effective March 2026. Dr. Claassen retains his Vanderbilt University Medical Center professorship and brings >20 years in movement disorders and neurodegenerative clinical research.

His prior role as coordinating investigator on the ATH434 Phase 2 study and experience as a principal investigator are cited as key qualifications to help advance ATH434 into Phase 3 for multiple system atrophy (MSA).

Alterity Therapeutics (NASDAQ: ATHE) recognizes Multiple System Atrophy Awareness Month and highlights its investigational oral therapy ATH434, advanced in clinical development for MSA. The company reported Phase 2 data showing meaningful clinical benefit with favorable safety and tolerability, and uses biomarkers and neuroimaging to assess impact.

Alterity will share educational content and support advocacy during March while continuing ATH434 development aimed at disease-modifying approaches for this rapidly progressive, currently untreatable disorder.

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.