Alterity Therapeutics Limited

– Official FDA minutes confirm the previously announced End-of-Phase 2 meeting outcomes and provide additional detail on the planned Phase 3 protocol —

globenewswire.com - 2026-07-07 07:05:00

Alterity Therapeutics Limited (NASDAQ:ATHE) stock is up during Tuesday's session as the biotechnology company announced an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its pivotal Phase 3 program for ATH434 in treating Multiple System Atrophy (MSA).

benzinga.com - 2026-06-09 11:41:42

– Successful End-of-Phase 2 meeting with FDA agreeing on key elements of the proposed Phase 3 design, including study population, dosing regimen, and treatment duration –

globenewswire.com - 2026-06-09 07:05:00

– Alterity's novel imaging and biomarker approach positions the Company at the forefront of clinical research in MSA –

globenewswire.com - 2026-05-19 07:25:00

– Peer-reviewed study from the bioMUSE Natural History Study shows advanced MRI method detects disease-specific iron accumulation that supports diagnosis and correlates with clinical severity in patients with Multiple System Atrophy (MSA) –

globenewswire.com - 2026-05-11 07:25:00

MELBOURNE, Australia and SAN FRANCISCO, May 07, 2026 (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 presentations related to the Company's development program in Multiple System Atrophy (MSA) will be delivered at multiple medical conferences in May 2026.

globenewswire.com - 2026-05-07 07:25:00

Highlights Aligned with the FDA in two Positive Type C meetings supporting key elements of the planned Phase 3 program for ATH434 in MSA Advancing ATH434 toward pivotal Phase 3 program; on track for End-of-Phase 2 FDA meeting mid-year 2026 Late breaking platform presentation at American Academy of Neurology annual meeting demonstrated consistent evidence of efficacy and reinforces ATH434's clinical profile Strengthened clinical leadership with appointment of Dr. Daniel Claassen as Chief Medical Advisor Enhanced Board of Directors with appointment of Ms. Ann Cunningham, bringing extensive global commercial and neurodegenerative disease expertise Hosted a virtual KOL event featuring leading experts to highlight clinical progress on MSA program and reinforce the scientific rationale for ATH434 Alterity continues to engage in discussions with a number of pharmaceutical companies regarding potential strategic collaboration opportunities for ATH434 Cash balance of A$44.53 million at 31 March 2026 MELBOURNE, Australia and SAN FRANCISCO, April 30, 2026 (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 2026 (Q3 FY26).

globenewswire.com - 2026-04-30 07:25:00

Alterity Therapeutics Limited (ATHE) Discusses Phase II Data and Development Strategy for ATH434 in Multiple System Atrophy Transcript

seekingalpha.com - 2026-04-28 20:41:52

MELBOURNE, Australia and SAN FRANCISCO, April 27, 2026 (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 positive regulatory feedback following a Type C Meeting with the U.S. Food and Drug Administration (FDA) regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy (MSA). MSA is a rare, rapidly progressive neurodegenerative disease with no approved disease-modifying treatments.

globenewswire.com - 2026-04-27 07:25:00

- ATH434 reduced functional decline vs placebo at Week 52 on MuSyCA, a newly described MSA composite scale - - Effects seen on both daily function and neurological examination, consistent with previously reported activity on modified UMSARS Part I - - Presentation reinforces ATH434's clinical profile ahead of Phase 3 engagement with regulators - MELBOURNE, Australia and SAN FRANCISCO, April 22, 2026 (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 the presentation of new data analyses from the Phase 2 trial of ATH434, demonstrating clinical efficacy in patients with Multiple System Atrophy (MSA). The analysis was delivered in an oral presentation during a Late Breaking Science Session at the American Academy of Neurology (AAN) Annual Meeting taking place in Chicago, IL, USA.

globenewswire.com - 2026-04-22 07:25:00