STOCK TITAN

Late-breaker ATH434 MSA results at AAN 2026 for Alterity (ATHE)

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Alterity Therapeutics Limited filed a Form 6-K highlighting a scientific milestone for its lead drug candidate ATH434. Daniel Claassen, M.D., Professor of Neurology at Vanderbilt University Medical Center and Chief Medical Advisor for Alterity, will present late-breaking clinical data at the American Academy of Neurology Annual Meeting in Chicago.

The oral presentation, titled “ATH434 Demonstrates Disease-Modifying Signal in Multiple System Atrophy Using the MuSyCA Composite Scale,” is scheduled for Tuesday, April 21, 2026 at 6:21 PM. ATH434 has shown clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 trial in Multiple System Atrophy and additional positive data in an open-label Phase 2 trial in advanced disease.

Alterity is a clinical stage biotechnology company focused on disease-modifying therapies for Multiple System Atrophy and related Parkinsonian disorders, and is preparing to initiate a Phase 3 pivotal trial in MSA. The company also maintains a broader discovery platform targeting underlying pathology in neurodegenerative diseases.

Positive

  • None.

Negative

  • None.
AAN Annual Meeting dates April 18-22, 2026 Conference window for American Academy of Neurology Annual Meeting in Chicago
Presentation date April 21, 2026 Date of ATH434 late-breaker oral presentation in Late-breaking Science 2 session
Presentation time 6:21 PM Scheduled time for ATH434 Multiple System Atrophy late-breaking oral presentation
Multiple System Atrophy medical
"ATH434 Demonstrates Disease-Modifying Signal in Multiple System Atrophy Using the MuSyCA Composite Scale"
A progressive neurological disorder that damages multiple areas of the nervous system, causing problems with movement, balance and involuntary functions like blood pressure and bladder control; think of it as critical wiring in the body slowly failing. Investors care because the condition defines the size and urgency of the market for treatments, influences clinical trial difficulty and regulatory risk, and can lead to high per-patient pricing but also greater development uncertainty.
Phase 3 pivotal trial medical
"Alterity is preparing to initiate a Phase 3 pivotal trial in MSA, a rare and rapidly progressive disease."
A phase 3 pivotal trial is the large, final clinical study that tests whether a new drug or medical treatment works and is safe enough for regulators to approve it for widespread use. Think of it as the full-scale dress rehearsal before a product launches: positive results can unlock regulatory approval and big commercial upside, while failures can halt a program and significantly affect investor value.
randomized, double-blind, placebo-controlled Phase 2 clinical trial medical
"ATH434, the Company’s lead asset, has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical trial"
open label Phase 2 clinical trial medical
"Alterity has further reported positive data in its open label Phase 2 clinical trial in participants with advanced MSA."
forward-looking statements regulatory
"This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
development stage enterprise financial
"ALTERITY THERAPEUTICS LIMITED (a development stage enterprise)"

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-163

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of April 2026

 

Alterity Therapeutics Limited

(Name of Registrant)

 

Level 14, 350 Collins Street, Melbourne, Victoria 3000 Australia

(Address of Principal Executive Office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒       Form 40-F ☐

 

This Form 6-K is being incorporated by reference into our Registration Statement on Form S-8 (Files No. 333-251073, 333-248980 and 333-228671) and our Registration Statements on Form F-3 (Files No. 333-274816, 333-251647, 333-231417 and 333-250076)

 

 

 

 

ALTERITY THERAPEUTICS LIMITED

(a development stage enterprise)

 

The following exhibits are submitted:

 

99.1

Alterity Announces Late-Breaker Oral Presentation at AAN

 

1

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

Alterity Therapeutics Limited

     
 

By:

/s/ Julian Babarczy

   

Julian Babarczy

   

Chairman

 

Date: April 16, 2026

2

Exhibit 99.1

 

ex_936910img001.jpg

 

 

Alterity Therapeutics Announces Late-Breaker Oral Presentation at the American Academy of Neurology Annual Meeting

 

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA  16 April 2026: Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that Daniel Claassen, M.D., M.S., Professor of Neurology at Vanderbilt University Medical Center and Chief Medical Advisor for Alterity, will deliver an oral presentation during a Late Breaking Session at the American Academy of Neurology (AAN) Annual Meeting taking place April 18-22, 2026 in Chicago, IL, USA.

 

Session:           Late-breaking Science 2

Type:               Oral Presentation

Title:                ATH434 Demonstrates Disease-Modifying Signal in Multiple System Atrophy Using the MuSyCA Composite Scale

Date/Time:      Tuesday, April 21, 2026, 6:21 PM CT

 

About Alterity Therapeutics Limited

 

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company is focused on developing disease modifying therapies in Multiple System Atrophy (MSA) and related Parkinsonian disorders. Alterity is preparing to initiate a Phase 3 pivotal trial in MSA, a rare and rapidly progressive disease. ATH434, the Company’s lead asset, has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with MSA. Alterity has further reported positive data in its open label Phase 2 clinical trial in participants with advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s website at https://alteritytx.com.

 

Authorisation & Additional information

This announcement was authorized by the Board of Alterity Therapeutics Limited.

 

Contacts:

 

Investors:

Elyse Shapiro

ir@alteritytx.com

 

Remy Bernarda

Investor Relations Advisory Solutions

ir@alteritytx.com

+1 (415) 203-6386

 

 

 

Media

 

Casey McDonald

Tiberend Strategic Advisors, Inc.

cmcdonald@tiberend.com

+1 (646) 577-8520

 

Forward Looking Statements

 

This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.

 

Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled Risk Factors in the Companys filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Companys drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Companys patent rights and the uncertainty of the Company freedom to operate.

 

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

 

 

FAQ

What did Alterity Therapeutics (ATHE) announce in this Form 6-K?

Alterity Therapeutics announced that Chief Medical Advisor Daniel Claassen will deliver a late-breaking oral presentation at the American Academy of Neurology Annual Meeting. The talk will cover ATH434 data showing a disease-modifying signal in Multiple System Atrophy using the MuSyCA Composite Scale.

When and where will Alterity Therapeutics present ATH434 data at AAN 2026?

The ATH434 presentation will occur during the Late-breaking Science 2 session at the AAN Annual Meeting in Chicago. It is scheduled for Tuesday, April 21, 2026, at 6:21 PM, highlighting late-breaking Multiple System Atrophy clinical results from Alterity’s lead program.

What is ATH434 in Alterity Therapeutics’ (ATHE) pipeline?

ATH434 is Alterity’s lead clinical asset targeting Multiple System Atrophy. It has demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 trial and has also produced positive data in an open-label Phase 2 trial in participants with advanced Multiple System Atrophy.

What disease areas is Alterity Therapeutics (ATHE) focused on?

Alterity Therapeutics focuses on neurodegenerative diseases, particularly Multiple System Atrophy and related Parkinsonian disorders. The company develops disease-modifying therapies and is preparing a Phase 3 pivotal trial in Multiple System Atrophy, a rare and rapidly progressive neurological disease with high unmet medical need.

What stage of development is Alterity Therapeutics’ MSA program?

Alterity’s Multiple System Atrophy program is in the clinical stage. ATH434 has completed Phase 2 trials with clinically meaningful efficacy and positive open-label results. The company is preparing to initiate a Phase 3 pivotal trial in MSA, aiming to advance toward potential registration studies.

Does Alterity Therapeutics (ATHE) have other programs beyond ATH434?

Beyond ATH434, Alterity maintains a broad drug discovery platform generating patentable chemical compounds to address underlying neurological disease pathology. This platform supports additional potential therapies for neurodegenerative conditions, complementing its lead Multiple System Atrophy program based in Melbourne and San Francisco.

Filing Exhibits & Attachments

1 document