Research analysts covering ALTERITY THERAPEUTICS.
Recent press releases and 8-K filings for ATHE.
Alterity Therapeutics Limited Reports Strengthened Phase 2 Data, Strong Cash Position, and Advances Phase 3 Planning
ATHE
New Projects/Investments
Board Change
Earnings
- Alterity Therapeutics Limited reported strengthened Phase 2 data for its ATH434 drug in Multiple System Atrophy (MSA), with additional analyses showing an improved relative treatment effect of 35% versus placebo for the 75 mg dose group at 52 weeks.
- The company is advancing regulatory planning for a pivotal Phase 3 program, targeting an FDA End-of-Phase 2 meeting in mid-2026.
- As of December 31, 2025, Alterity held a strong cash balance of A$49.2 million, providing an estimated 9.3 quarters of funding based on current operating cash outflows.
- Partnering and strategic discussions are underway with pharmaceutical companies to explore non-dilutive funding pathways for Phase 3 development.
- Julian Babarczy was appointed Chair of the Board, and CEO Dr. David Stamler was appointed Managing Director in November 2025, strengthening governance and leadership.
8 days ago
Alterity Therapeutics Reports Q2 FY26 Cash Flow and Corporate Update
ATHE
New Projects/Investments
Board Change
- Alterity Therapeutics reported its financial position for Q2 FY26, with key figures detailed in the table below.
| Metric | Q2 FY26 |
|---|---|
| Cash balance (A$ Millions) | 49.2 |
| Operating cash outflows (A$ Millions) | 5.28 |
- The company strengthened its Phase 2 data for ATH434 in Multiple System Atrophy (MSA) and is advancing regulatory planning for a pivotal Phase 3 program, including an FDA End-Of-Phase-2 meeting in mid-2026.
- Alterity is engaged in partnering and strategic discussions with pharmaceutical companies to explore non-dilutive pathways to fund Phase 3 development for ATH434, which has a potential commercial opportunity of US$2.4 billion in MSA.
- The Board and executive leadership were strengthened during the quarter, with Julian Babarczy appointed Chair and CEO Dr. David Stamler appointed Managing Director.
8 days ago
Alterity Therapeutics Issues Shareholder Letter on 2025 Progress and 2026 Objectives
ATHE
New Projects/Investments
Board Change
- Alterity Therapeutics successfully completed its Phase 2 program for ATH434 in Multiple System Atrophy (MSA) in 2025, with results indicating the drug was safe and well-tolerated and showed strong signals of efficacy in slowing disease progression.
- The company is now preparing to advance ATH434 into a pivotal Phase 3 clinical program for MSA, aiming for potential entry into an estimated $2.4 billion market opportunity.
- A key objective for 2026 is to hold an End-of-Phase 2 meeting with the FDA in mid-2026 to finalize the Phase 3 study design, which is the final regulatory step before initiating the trial.
- In 2025, Alterity enhanced its leadership, appointing Julian Babarczy as the new Chair of the Board in November and expanding its leadership team with new roles in investor relations and corporate strategy.
Jan 21, 2026, 12:25 PM
Alterity Therapeutics Highlights 2025 Progress and Outlines 2026 Objectives
ATHE
New Projects/Investments
Board Change
Guidance Update
- Alterity Therapeutics successfully completed its Phase 2 program for ATH434 in Multiple System Atrophy (MSA) in 2025, with data demonstrating the drug's safety, tolerability, and strong signals of efficacy in slowing disease progression across multiple clinical endpoints.
- The company is focused on advancing ATH434 towards a pivotal Phase 3 clinical program in MSA, with an End-of-Phase 2 meeting with the FDA expected in mid-2026 to finalize the Phase 3 design.
- Key objectives for 2026 include finalizing the regulatory strategy to initiate the Phase 3 trial, deepening external engagement across various communities, and building for scalable growth, including expanding intellectual property protection.
- In 2025, Julian Babarczy was appointed as the new Chair of the Board, and the leadership team was expanded with new roles in Investor Relations and Corporate Strategy.
Jan 21, 2026, 2:56 AM
Alterity Therapeutics Reports Positive Phase 2 Results for ATH434 in MSA and Outlines Commercial Opportunity
ATHE
New Projects/Investments
- Alterity Therapeutics announced positive Phase 2 data for its drug candidate ATH434 in Multiple System Atrophy (MSA), demonstrating clinically significant efficacy in slowing disease progression and a favorable safety profile.
- Independent market research projects a potential worldwide annual peak sales of $2.4 billion for ATH434 in MSA, with over 70% of neurologists indicating they would be "extremely likely" or "very likely" to prescribe it based on its profile.
- The company plans to finalize its regulatory strategy with the US FDA for the pivotal Phase 3 clinical trial protocol and conduct an End of Phase 2 meeting mid-year 2026.
- As of September 30, Alterity Therapeutics reported a cash balance of A$54.5 million.
Jan 13, 2026, 1:00 PM
Alterity Therapeutics Limited Announces 2025 Annual General Meeting Results
ATHE
Proxy Vote Outcomes
- Alterity Therapeutics Limited filed a 6-K on November 21, 2025, reporting the results of its 2025 Annual General Meeting held on the same date, detailing the resolutions passed by shareholders.
- Alterity Therapeutics is a clinical stage biotechnology company dedicated to developing disease-modifying therapies for neurodegenerative diseases, with an initial focus on Parkinson's disease and related disorders.
- The company's lead asset, ATH434, has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical trial for Multiple System Atrophy (MSA) and recently reported positive data in its open-label Phase 2 clinical trial for advanced MSA.
Nov 21, 2025, 11:35 AM
Alterity Therapeutics Reports Positive Phase 2 Results for ATH434 in Multiple System Atrophy
ATHE
New Projects/Investments
Product Launch
- Alterity Therapeutics' drug candidate, ATH434, has demonstrated positive Phase 2 data in Multiple System Atrophy (MSA), an aggressive Parkinsonian disorder for which there is currently no approved treatment.
- The ATH434-201 randomized, double-blind study showed clinically meaningful efficacy on the modified UMSARS Part I, an FDA-endorsed clinical endpoint, with a 48% relative treatment effect for the 50 mg dose (P=0.02).
- The company projects USD $2.4 Billion in potential worldwide annual peak sales for ATH434 in MSA, with over 70% of neurologists indicating they would be "extremely likely" or "very likely" to prescribe it based on its profile.
- ATH434 has received Orphan Drug and Fast Track designations from the US FDA for MSA, and Phase 3 trial planning is ongoing, with an End-of-Phase 2 meeting expected in mid-2026.
- As of September 30, 2025, Alterity Therapeutics reported a cash balance of A$54.5 million.
Nov 21, 2025, 11:29 AM
Alterity Therapeutics Limited receives disclosure of equity derivative positions
ATHE
New Projects/Investments
Takeover Bid
- Alterity Therapeutics Limited received a disclosure on November 13, 2025, from Regal Funds Management Asia Pte Limited regarding long equity derivative positions held by two funds.
- As of November 10, 2025, the Amazon Market Neutral Fund held derivatives relating to 50,000,000 securities (0.46%) of Alterity Therapeutics Limited.
- As of November 10, 2025, the Zambezi Absolute Return Fund held derivatives relating to 503,141,403 securities (4.63%) of Alterity Therapeutics Limited.
Nov 13, 2025, 11:38 AM
Alterity Therapeutics Presents Promising ATH434 Phase 2 Results for MSA
ATHE
New Projects/Investments
Guidance Update
- Alterity Therapeutics presented promising analyses from its ATH434-201 Phase 2 clinical trial for Multiple System Atrophy (MSA) at the 36th International Symposium on the Autonomic Nervous System on November 10, 2025.
- The analysis revealed that accounting for orthostatic hypotension (OH) strengthened the efficacy signal in the 75 mg dose group, improving the relative treatment effect from 30% to 35% on the UMSARS I at 52 weeks.
- ATH434 demonstrated symptom stability in both 50 mg and 75 mg dose groups over 52 weeks, contrasting with a worsening of approximately 6 points in placebo patients on the OH Symptom Assessment.
- The company is actively planning the Phase 3 protocol and preparing for FDA interactions for ATH434, which holds Fast Track Designation by the U.S. FDA and Orphan Drug Designation by the FDA and European Commission.
Nov 10, 2025, 1:00 PM
Alterity Therapeutics Reports Q1 FY26 Financials and Clinical Progress
ATHE
Earnings
New Projects/Investments
Guidance Update
- Alterity Therapeutics reported a cash balance of A$54.56 million on September 30, 2025, with operating cash outflows of A$5.34 million for the quarter, and raised A$20 million from a strategic placement.
- New analysis of the ATH434-201 trial showed a strengthened efficacy signal at the high dose level, and positive data from the ATH434-202 open-label trial demonstrated a similar treatment effect in advanced MSA.
- An independent commercial assessment indicated a potential worldwide peak sales opportunity of USD$2.4 billion for ATH434 in MSA.
- The company is actively engaging with the U.S. FDA for ATH434, with an End-of-Phase 2 meeting expected in mid-2026 to enable the initiation of a Phase 3 trial.
Oct 31, 2025, 11:12 AM
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