Alterity Therapeutics Ltd Stock Price, News & Analysis

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.

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.

Alterity Therapeutics (NASDAQ: ATHE) reported significant progress in Q4 FY25 for its lead drug candidate ATH434 for Multiple System Atrophy (MSA). The company received FDA Fast Track Designation and reported positive data from two Phase 2 clinical trials. The double-blind study showed 48% reduction in disease severity at 50mg dose and 30% at 75mg dose. The open-label trial demonstrated clinical benefits and slowed brain atrophy.

The company maintains a strong financial position with A$40.66M cash balance as of June 30, 2025, after raising A$26.3M through a placement and receiving an A$3.98M R&D tax incentive refund. Operating cash outflows for the quarter were A$2.35M.

Alterity Therapeutics (NASDAQ: ATHE) announced positive topline data from its ATH434-202 open-label Phase 2 clinical trial for treating Multiple System Atrophy (MSA). The trial demonstrated that ATH434 reduced disease progression by approximately 50% compared to historical controls over 12 months, as measured by the Modified Unified MSA Rating Scale Part I.

Key findings include: 30% of participants reported stable neurological symptoms, stabilization of orthostatic hypotension symptoms, and slowed brain atrophy in MSA-affected areas. The drug showed a favorable safety profile with no serious adverse events related to treatment. Importantly, these results were consistent with the company's previous double-blind Phase 2 trial (ATH434-201), supporting the advancement of ATH434 in MSA treatment.