ALTERITY THERAPEUTICS LTD
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See all $ATHE insider activity →Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) said the USPTO granted a new U.S. composition of matter patent for ATH434, covering a crystalline mesylate form and treatment methods. The patent extends protection to at least 2045 and supports Phase 3 MSA plans by year-end 2026, with potential expansion to Parkinson’s disease.
Alterity Therapeutics (ATHE) discussed at Canaccord Genuity’s Growth Conference its lead drug ATH434 for multiple system atrophy. The company said Phase II showed 34% to 46% slower decline versus placebo on the MSA Rating Scale, and FDA alignment on Phase III design, with a planned 200-patient, 12-month trial using 50 mg twice daily. It modeled peak sales of $2.4B.
Alterity Therapeutics said FDA end-of-Phase 2 meeting minutes for ATH434 in multiple system atrophy confirm a registrational plan: one pivotal Phase 3 trial plus confirmatory evidence could support approval. The Phase 3 is expected to start by year-end 2026, enrolling ~200 patients randomized 1:1 to ATH434 50 mg vs placebo twice daily for 12 months.
Over the past 7 days, alphai's AI scored 2 news stories mentioning ATHE (ALTERITY THERAPEUTICS LTD). Coverage has skewed bullish: 2 bullish, 0 neutral, and 0 bearish.
Recent ATHE coverage spans financial news, regulation and corporate actions.
Patent grant strengthens ATH434’s IP moat and supports the company’s Phase 3 MSA timeline, with optionality for Parkinson’s.
Conference update strengthens the probability of a successful Phase III readout by confirming FDA-aligned endpoints and dosing, while highlighting remaining late-stage risk.
FDA alignment on a single pivotal Phase 3 plus confirmatory evidence reduces regulatory uncertainty for ATH434’s NDA path.
FDA alignment on a single pivotal Phase 3 plus confirmatory evidence reduces regulatory uncertainty and de-risks the Phase 3 execution plan.
Regulatory alignment on Phase 3 protocol and written CMC feedback materially reduces clinical/regulatory uncertainty for ATH434’s pivotal path.
alphai scores every news story that mentions ATHE with an AI model for sentiment and relevance, and aggregates insider trades from ALTERITY THERAPEUTICS LTD's SEC EDGAR Form 4 filings. Figures refresh continuously.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) said the USPTO granted a new U.S. composition of matter patent for ATH434, covering a crystalline mesylate form and treatment methods. The patent extends protection to at least 2045 and supports Phase 3 MSA plans by year-end 2026, with potential expansion to Parkinson’s disease.
4 min readAlterity Therapeutics (ATHE) discussed at Canaccord Genuity’s Growth Conference its lead drug ATH434 for multiple system atrophy. The company said Phase II showed 34% to 46% slower decline versus placebo on the MSA Rating Scale, and FDA alignment on Phase III design, with a planned 200-patient, 12-month trial using 50 mg twice daily. It modeled peak sales of $2.4B.
6 min readAlterity Therapeutics said FDA end-of-Phase 2 meeting minutes for ATH434 in multiple system atrophy confirm a registrational plan: one pivotal Phase 3 trial plus confirmatory evidence could support approval. The Phase 3 is expected to start by year-end 2026, enrolling ~200 patients randomized 1:1 to ATH434 50 mg vs placebo twice daily for 12 months.
3 min readAlterity Therapeutics said FDA end-of-Phase 2 meeting minutes for ATH434 in multiple system atrophy confirm a registrational plan: one pivotal Phase 3 trial plus confirmatory evidence could support approval. The Phase 3 is expected to enroll ~200 patients, randomized 1:1 to ATH434 50 mg or placebo twice daily for 12 months, with initiation by year-end 2026.
4 min readAlterity Therapeutics said the FDA agreed on key elements of the Phase 3 trial design for ATH434, including the study population and dosing regimen, after Phase 2 results showed 48% slowing of disease progression vs placebo. The company expects Phase 3 activities to start by year-end 2026. Alterity also cited April Phase 2 analyses and positive FDA Type C feedback on CMC.
5 min readThis page provides access to Alterity Therapeutics Ltd (ATHE) SEC filings, including 10-K, 10-Q, and 8-K forms, as well as insider trading disclosures. As a foreign private issuer, Alterity primarily files 20-F annual reports and 6-K current reports, which often contain crucial updates on clinical trials for ATH434, regulatory statuses, and financial information. The platform also offers AI-powered summaries and sentiment analysis for these filings to assist investors.
3 min readAlterity Therapeutics (ATHE) director Ann Michelle Cunningham has filed an initial Form 3 insider ownership report, indicating her status as a director but showing no reported transactions or derivative positions. This filing serves as a baseline disclosure of her beneficial ownership rather than an update to previous trading activity. A Form 3 is required when an individual becomes an insider, establishing a starting point for observing future stock transactions.
2 min readAlterity Therapeutics is highlighting Multiple System Atrophy (MSA) Awareness Month and the urgent need for disease-modifying treatments. The company is advancing its investigational oral therapy, ATH434, which has shown meaningful clinical benefit and a favorable safety profile in Phase 2 trials for MSA, a rapidly progressive neurodegenerative disease with no approved therapies. Alterity plans to initiate a Phase 3 pivotal trial for ATH434, which has received Fast Track and Orphan Drug Designations.
3 min readMELBOURNE, 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 ...
2 min readMELBOURNE, 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 ...
2 min read
