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ALTERITY THERAPEUTICS (ATHE)

Executive leadership at ALTERITY THERAPEUTICS.

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Recent press releases and 8-K filings for ATHE.

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.
6 days ago
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
Alterity Therapeutics Ltd to Vote on Share Issuance Ratification, Equity Plans, and Director Re-election
ATHE
Executive Compensation
New Projects/Investments
  • Shareholders will vote on the ratification of 1,666,666,663 Placement Shares issued on September 15, 2025, at $0.012 each, which raised $20 million for non-clinical studies, chemical manufacturing and controls (CMC) activities, clinical and regulatory activities for ATH434 in MSA, and general working capital.
  • The company is seeking approval for the issue of up to 500,000,000 Incentives under the 2004 ASX Plan and up to 500,000,000 Incentives under the 2018 ADS Plan, as well as an additional 10% placement capacity which could allow for the issuance of approximately 1,087,541,632 Equity Securities based on shares outstanding as of October 14, 2025.
  • Shareholders will also vote on the re-election of Mr. Brian Meltzer as a Director and the adoption of a new Constitution.
Oct 21, 2025, 10:51 AM
Alterity Therapeutics Presents Positive ATH434 Phase 2 Trial Data for MSA
ATHE
Product Launch
New Projects/Investments
  • Alterity Therapeutics presented positive data from its ATH434 Phase 2 clinical trial for Multiple System Atrophy (MSA) at the 2025 International Congress of Parkinson’s Disease and Movement Disorders on October 9, 2025.
  • The trial data demonstrated that ATH434 slows disease progression and stabilizes orthostatic hypotension in MSA patients.
  • Treatment with ATH434 resulted in a clinically significant reduction in disease severity on the modified UMSARS I scale, showing a 48% relative treatment effect at the 50 mg dose and a 30% relative treatment effect at the 75 mg dose at 52 weeks.
  • A new analysis, accounting for baseline differences, strengthened the efficacy signal for the 75 mg dose to a 35% relative treatment effect.
  • ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious adverse events attributed to the drug. It has also been granted Fast Track Designation and Orphan Drug Designation by the FDA and European Commission for MSA.
Oct 9, 2025, 10:33 AM
Alterity Therapeutics to Present Positive Phase 2 Data for ATH434 at MDS Conference
ATHE
New Projects/Investments
  • Alterity Therapeutics (ATHE) announced it will present positive data from its ATH434-201 double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS) from October 5-9, 2025.
  • The presentations will include an oral platform presentation by CEO David Stamler, M.D., on October 8, 2025, highlighting that ATH434 slowed disease progression in the Phase 2 study.
  • The Phase 2 trial demonstrated robust clinical efficacy, target engagement on key biomarkers, and a favorable safety profile for ATH434, showing clinically and statistically significant improvement on the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I.
  • ATH434, Alterity's lead candidate, has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation from the FDA and the European Commission for the treatment of MSA.
Oct 2, 2025, 10:26 AM
Alterity Therapeutics Presents Positive Phase 2 Data for ATH434 in MSA
ATHE
Product Launch
New Projects/Investments
  • Alterity Therapeutics presented positive data from its ATH434-201 Phase 2 clinical trial for Multiple System Atrophy (MSA) at the American Neurological Association Annual Meeting on September 15, 2025.
  • The study demonstrated clinically meaningful efficacy in modifying disease progression at both 50 mg and 75 mg doses, showing clinically and statistically significant improvement on the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I.
  • ATH434 was well tolerated with similar adverse event rates as placebo, and no serious adverse events were attributed to the study drug.
  • The drug also showed target engagement by reducing iron accumulation in MSA affected brain regions and has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation from both the FDA and the European Commission for the treatment of MSA.
Sep 15, 2025, 12:04 PM
Alterity Therapeutics Presents Positive Phase 2 Data for ATH434-201
ATHE
  • Alterity Therapeutics presented data from its ATH434-201 randomized, double-blind Phase 2 clinical trial for Multiple System Atrophy (MSA) at the 150th Annual Meeting of the American Neurological Association.
  • The study demonstrated that ATH434 slowed disease progression in MSA patients at both 50 mg and 75 mg doses, showing clinically meaningful efficacy and target engagement by reducing iron accumulation in affected brain regions.
  • ATH434 was well tolerated, with adverse event rates similar to placebo and no serious adverse events attributed to the study drug.
  • ATH434 has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation from both the FDA and the European Commission for MSA treatment.
Sep 15, 2025, 11:26 AM
Alterity Therapeutics Limited applies for quotation of new shares following option exercise
ATHE
Executive Compensation
Delisting/Listing Issues
  • Alterity Therapeutics Limited applied for the quotation of 79,999,800 new Ordinary Fully Paid shares (ATH) on July 17, 2025, which were issued due to the exercise of options under an employee incentive scheme.
  • These options were exercised for a cash consideration of USD 0.00300000 per security, with David Stamler, a Key Management Personnel, exercising 79,999,800 of these options.
  • Following this quotation, the total number of Ordinary Fully Paid shares (ATH) will increase to 9,207,370,486.
Jul 17, 2025, 12:00 AM
Alterity Therapeutics Responds to ASX Price Query
ATHE
Delisting/Listing Issues
New Projects/Investments
  • Alterity Therapeutics Limited (ATHE) filed a 6-K on July 14, 2025, in response to an ASX price query regarding a significant increase in its share price and trading volume between July 10 and July 11, 2025.
  • The company stated it is not aware of any unannounced information that could explain the recent trading activity in its securities.
  • Alterity Therapeutics noted that it expects to release finalized Phase 2 data from the ATH-201 study and open-label data from the ATH-202 study in mid-year 2025, which could be contributing to market anticipation.
  • An upcoming Non-Deal Roadshow is scheduled from July 31 to August 6, 2025, involving investor meetings.
Jul 14, 2025, 12:00 AM

Recent SEC filings and earnings call transcripts for ATHE.

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