Alterity Therapeutics Limited (ATHE)

MELBOURNE, Australia and SAN FRANCISCO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that David Stamler, M.D., Chief Executive Officer of Alterity, will deliver a corporate update at the Bell Potter Healthcare Conference, a virtual event showcasing Australia's best healthcare companies.

Highlights New analysis of ATH434-201 double blind trial strengthens efficacy signal at high dose level Positive data from ATH434-202 open-label trial demonstrates similar treatment effect in advanced MSA as observed in earlier stage patients in double-blind study Independent commercial assessment indicates USD $2.4 billion dollar potential worldwide peak sales opportunity in MSA for ATH434 Cash balance on 30 September 2025 of A$54.56M MELBOURNE, Australia and SAN FRANCISCO, Oct. 31, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 September 2025 (Q1 FY26). “As we near the end of the calendar year, I am very proud of all we have accomplished in 2025, led by our compelling clinical results in Multiple System Atrophy (MSA), and I am excited about the prospect of delivering ATH434 to the MSA community,” said David Stamler, M.D.

– Data demonstrate ATH434 slows disease progression and stabilizes orthostatic hypotension – – New analysis increases overall confidence in the Phase 2 trial results – – State-of-the-art neuroimaging and biomarker analysis advance understanding of MSA diagnosis – MELBOURNE, Australia and SAN FRANCISCO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced  that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) was featured at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS) that took place in Honolulu, HI, USA. “The aggregate data from our double-blind trial continue to demonstrate the potential of ATH434 as a disease modifying therapy for MSA,” said David Stamler, M.D.

– Data from ATH434-201 double-blind Phase 2 trial to be featured in oral session and multiple poster presentations –

MELBOURNE, Australia and SAN FRANCISCO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced it has received binding commitments for a capital raising of A$20.0 million (the “Placement”) of fully paid ordinary shares (“New Shares”) to International and Australian professional investors.

MELBOURNE, Australia and SAN FRANCISCO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that David Stamler, M.D., Chief Executive Officer of Alterity, will deliver a corporate update at the Biotech Showcase hosted by Peak Asset Management and Monsoon Communications. The presentation will take place on Wednesday, 3 September 2025 in Australia; Tuesday, 2 September 2025 in the United States.

Highlights Granted U.S. FDA Fast Track Designation for ATH434 to treat Multiple System Atrophy (MSA) Reported positive topline data from open-label Phase 2 clinical trial of ATH434 in MSA Presented additional analyses from the ATH434-201 trial demonstrating continued robust efficacy for the treatment of MSA Cash balance on 30 June 2025 of A$40.66M MELBOURNE, Australia and SAN FRANCISCO, July 30, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 June 2025 (Q4 FY25). “U.S. FDA Fast Track designation for ATH434 in MSA was the highlight of the recent quarter that also featured additional positive clinical data from our Phase 2 double-blind trial,” said David Stamler, M.D.

– ATH434 Demonstrated Clinical Benefit on the Unified MSA Rating Scale and Global Measures of Neurological Symptoms –

– Peer-reviewed publication in Annals of Clinical and Translational Neurology highlights the use of the MSA Atrophy Index developed to diagnose and track disease progression in Multiple System Atrophy –

MELBOURNE, Australia and SAN FRANCISCO, June 23, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that David Stamler, M.D., Chief Executive Officer of Alterity, will participate in a Fireside Chat hosted by MST Access on Wednesday, 25 June 2025 in Australia / Tuesday, 24 June 2025 in the United States. Dr. Stamler will provide a corporate update with a focus on the progress made on the ATH434 development program in Multiple System Atrophy since the Company released positive Phase 2 data in January.

– ATH434 Phase 2 data demonstrated clinically meaningful efficacy on multiple clinical endpoints – – MSA Atrophy Index (MSAai) enhances MSA diagnosis and monitoring – – bioMUSE Study shows higher α- synuclein concentration is associated with greater burden of orthostatic symptoms – MELBOURNE, Australia and SAN FRANCISCO, May 12, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that several oral and poster presentations related to Alterity's clinical programs in Multiple System Atrophy (MSA) were featured at the 2025 International MSA Congress. The Congress was presented by Mission MSA, a non-profit organization dedicated to improving the quality of life and building hope for people affected by MSA through support services, educational resources, research funding, and community engagement.

MELBOURNE, Australia and SAN FRANCISCO, May 07, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that multiple oral and poster presentations related to Alterity's clinical programs in Multiple System Atrophy (MSA) will be featured at the 2025 International MSA Congress taking place May 9 - 11, 2025 in Boston, MA, USA. The Congress is presented by Mission MSA, a non-profit organization dedicated to improving the quality of life and building hope for people affected by MSA through support services, educational resources, research funding, and community engagement.

– Fast Track Designation highlights potential of ATH434 to address high unmet need for individuals with MSA – MELBOURNE, Australia and SAN FRANCISCO, May 05, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ATH434 for the treatment of Multiple System Atrophy (MSA). This designation is intended to accelerate the development and review of novel investigational products such as ATH434 and recognizes its potential as an innovative approach to address the high unmet need for treating MSA, a disease with no approved therapy.

Highlights Reported positive topline data for ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) led by robust clinical efficacy Phase 2 data featured in an oral presentation at the American Academy of Neurology Annual Meeting ATH434-202 open-label trial in advanced MSA completed in March 2025 Cash balance on 31 March 2025 of A$17.96M with an additional A$27.1M raised subsequent to the end of the quarter MELBOURNE, Australia and SAN FRANCISCO, April 30, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31 March 2025 (Q3 FY25). David Stamler, M.D.

MELBOURNE, Australia and SAN FRANCISCO, April 28, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that David Stamler, M.D., Chief Executive Officer presented the ATH434-201 Phase 2 clinical trial results at the annual MSA Research Symposium hosted by University College London, Institute of Neurology in partnership with the MSA Trust of the U.K.

– Clinically Meaningful Efficacy Observed on Multiple Assessments – – Confirmed Target Engagement with Reduced Iron Signal in MSA Affected Brain Regions – MELBOURNE, Australia and SAN FRANCISCO, April 10, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that new presentations related to its Multiple System Atrophy (MSA) program were delivered at the American Academy of Neurology (AAN) 2025 Annual Meeting, one of the premier global neurology meetings. Notably, new data from the ATH434-201 trial was prominently featured via an oral presentation during a Scientific Platform Session on Movement Disorders.