Highlights FDA End-of-Phase 2 meeting minutes confirmed the Phase 3 trial design and registrational pathway for ATH434 in Multiple System Atrophy (MSA)New U.S. composition of matter patent granted for ATH434, extending
MELBOURNE, Australia and SAN FRANCISCO, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Alterity Therapeutics ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing
ATH434 50 mg significantly slowed functional decline in MSA by approximately 52% versus placebo on the 11-item UMSARS at Week 52 with CSF NfL as a covariate Baseline CSF NfL predicted the rate of functional decline,
MELBOURNE, Australia and SAN FRANCISCO, Sept. 03, 2026 (GLOBE NEWSWIRE) -- Alterity Therapeutics ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing
– Newly granted patent extends protection for ATH434 to at least 2045, significantly enhancing its strategic value and long-term commercial potential – – Strengthens ATH434’s intellectual property portfolio as it
MELBOURNE, Australia and SAN FRANCISCO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Alterity Therapeutics ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing
Highlights FDA End-of-Phase 2 (EOP2) meeting minutes confirmed a registrational pathway for ATH434 in Multiple System Atrophy (MSA)FDA agreed that a single pivotal Phase 3 trial plus confirmatory evidence could support
MELBOURNE, Australia and SAN FRANCISCO, July 21, 2026 (GLOBE NEWSWIRE) -- Alterity Therapeutics ((ASX: ATH, NASDAQ:ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing
– Official FDA minutes confirm the previously announced End-of-Phase 2 meeting outcomes and provide additional detail on the planned Phase 3 protocol — – FDA agreed that a single pivotal Phase 3 trial plus confirmatory
– 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 – – FDA agrees on UMSARS Part I as primary
– Alterity's novel imaging and biomarker approach positions the Company at the forefront of clinical research in MSA – – End-of-Phase 2 FDA Meeting on track for mid-2026 to confirm path forward for Phase 3 –
– 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
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
Highlights Aligned with the FDA in two Positive Type C meetings supporting key elements of the planned Phase 3 program for ATH434 in MSAAdvancing ATH434 toward pivotal Phase 3 program; on track for End-of-Phase 2 FDA
– Alignment reached on chemistry, manufacturing, and control (CMC) elements of ATH434 Phase 3 development program – – Positive feedback supports readiness for Phase 3 initiation with manufacturing scale-up progressing
