Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy

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 ...
The Lancet

A step towards disease-modifying therapy for multiple system atrophy

Multiple system atrophy (MSA) is an adult-onset, rapidly progressive neurodegenerative disorder characterised by the aggregation of α-synuclein in oligodendroglial cytoplasmatic inclusions.1 ...
Monthly Prescribing Reference

Emrusolmin Fast Tracked for Multiple System Atrophy

Emrusolmin is expected to improve symptoms of MSA by targeting alpha synuclein oligomers. The Food and Drug Administration (FDA) has granted Fast Track designation to emrusolmin (TEV-56286) for the ...

Alterity Therapeutics Releases Appendix 4C – Q3 FY26 Quarterly Cash Flow Report & Corporate Update

Highlights Aligned with the FDA in two Positive Type C meetings supporting key elements of the planned Phase 3 program for ATH434 in MSAAdvancing ...
The Manila Times

Alterity Therapeutics to Host Virtual KOL Event to Share New Insights on ATH434 for the Treatment of Multiple System Atrophy

Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ('Alterity” or 'the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today ...
Monthly Prescribing Reference

Iron Chaperone Granted Fast Track Status for Multiple System Atrophy

Compared with placebo, ATH434 demonstrated a statistically significant 48% slowing of clinical progression (based on UMSARS score) at the 50mg dose at week 52. The Food and Drug Administration (FDA) ...
TMCnet

AskBio's Viralgen to Supply Commercial-Scale Drug Product for REGENERATE-PD Investigational Gene Therapy Phase II Trial for Parkinson's Disease

Ametefgene parvec (AB-1005) manufactured at Viralgen commercial manufacturing facility with next-generation process to deliver high-purity product with greater efficiency   AskBio Inc. (AskBio), a ...
Seeking Alpha

Alterity Therapeutics Recognizes Multiple System Atrophy (MSA) Awareness Month in March and the Urgent Need for Disease-Modifying Treatments

– Company is advancing ATH434 in late-stage clinical development for Multiple System Atrophy, a rapidly progressive neurodegenerative disease with no approved therapies – MSA is a progressive ...
clinicaladvisor.com

Multiple System Atrophy: A Common Form of Atypical Parkinsonism

Currently no disease-modifying or neuroprotective treatments exist for MSA, nor are there effective medications to treat the cerebellar ataxia in MSA-C or the parkinsonian features in MSA-P. Physical ...
Seeking Alpha

FDA Approves Tiziana Life Sciences Phase 2 IND for Multiple System Atrophy

NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (TLSA) (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies ...
Business Insider

Alterity Therapeutics Recognizes Multiple System Atrophy (MSA) Awareness Month in March and the Urgent Need for Disease-Modifying Treatments

– Company is advancing ATH434 in late-stage clinical development for Multiple System Atrophy, a rapidly progressive neurodegenerative disease with no approved therapies – MELBOURNE, Australia and SAN ...