Alterity gains FDA support on ATH434 Phase 3 plans

Alterity Therapeutics Limited reports that the U.S. FDA has provided positive regulatory feedback in a second Type C Meeting on its planned Phase 3 program for ATH434 in Multiple System Atrophy (MSA).

Rhea-AI Filing Summary

Alterity Therapeutics Limited reports that the U.S. FDA has provided positive regulatory feedback in a second Type C Meeting on its planned Phase 3 program for ATH434 in Multiple System Atrophy (MSA). The agency and company reached alignment on key chemistry, manufacturing, and control (CMC) elements, supporting readiness for Phase 3 initiation while manufacturing scale-up progresses in parallel. An End-of-Phase 2 meeting with the FDA remains on track for mid-2026, positioning ATH434 for a pivotal trial in this rare, rapidly progressive neurodegenerative disease with no approved disease-modifying treatments.

Positive

• FDA alignment on ATH434 CMC for Phase 3: The FDA provided positive feedback and endorsed Alterity’s chemistry, manufacturing, and control plans for ATH434, reducing a key source of regulatory risk ahead of the planned pivotal Phase 3 trial in Multiple System Atrophy.
• Clear regulatory path toward pivotal trial: With two Type C Meetings completed and an End-of-Phase 2 meeting on track for mid-2026, the ATH434 program now has structured FDA interaction supporting readiness for Phase 3 initiation in a rare disease lacking disease-modifying treatments.

Negative

• None.

Insights

Biotech regulatory and clinical development analyst

Positive FDA feedback de-risks ATH434’s path into Phase 3 MSA trials.

The FDA’s endorsement of ATH434 plans after a second Type C Meeting is a key regulatory milestone for Alterity Therapeutics. Alignment on chemistry, manufacturing, and control (CMC) means the company’s technical package for Phase 3 and potential commercialization has cleared an important hurdle.

Manufacturing scale-up is progressing in parallel with Phase 3 planning, which may help avoid delays once the pivotal trial is ready to start. An End-of-Phase 2 meeting targeted for mid-2026 will be crucial to finalize the overall Phase 3 design in Multiple System Atrophy, a disease with no approved disease-modifying therapies.

For investors, this update reduces regulatory uncertainty around ATH434’s development path but does not remove clinical or financing risks described in existing risk disclosures. Subsequent company reports around the End-of-Phase 2 meeting in 2026 will likely clarify the Phase 3 protocol and timelines.

Key Figures

Second Type C Meeting: 2nd meeting Phase 3 development stage: Phase 3 End-of-Phase 2 meeting timing: mid-2026 +2 more

5 metrics

Second Type C Meeting 2nd meeting Second FDA Type C Meeting on ATH434 Phase 3 program

Phase 3 development stage Phase 3 Planned pivotal program for ATH434 in Multiple System Atrophy

End-of-Phase 2 meeting timing mid-2026 Target timing for FDA End-of-Phase 2 meeting on ATH434

Form 6-K exhibit Exhibit 99.1 Press release detailing FDA feedback on ATH434 Phase 3 plans

Announcement date 27 April 2026 Date of press release from Melbourne and San Francisco

Key Terms

Type C Meeting, chemistry, manufacturing, and control (CMC), End-of-Phase 2 meeting, Multiple System Atrophy, +2 more

6 terms

Type C Meeting regulatory

"received positive regulatory feedback following a Type C Meeting with the U.S. Food and Drug Administration"

chemistry, manufacturing, and control (CMC) technical

"alignment reached on chemistry, manufacturing, and control (CMC) elements of ATH434 Phase 3 development program"

Chemistry, manufacturing, and control (CMC) covers the recipe, production process, and quality checks for making a drug or biologic, including the ingredients, how it’s made, and how consistent and safe each batch is. Investors care because strong CMC reduces the risk of regulatory delays, costly recalls, or failed approvals—think of it as both the recipe and the factory inspection that determine whether a product can be reliably produced at scale and sold.

End-of-Phase 2 meeting regulatory

"End-of-Phase 2 meeting with FDA remains on track for mid-2026"

An end-of-phase 2 meeting is a formal discussion between a drug developer and a regulatory agency to review mid-stage clinical results and agree on the plan and requirements for the larger, final tests needed for approval. It matters to investors because the meeting can clarify what evidence regulators will require, shape the cost and timeline for the next phase, and reduce uncertainty about whether a drug can advance toward market — like a checkpoint that determines whether a project gets the green light to move to the next, expensive stage.

Multiple System Atrophy medical

"ATH434 Phase 3 Program in Multiple System Atrophy"

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.

disease modifying treatments medical

"a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases"

development stage enterprise financial

"ALTERITY THERAPEUTICS LIMITED (a development stage enterprise)"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

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

Alterity Therapeutics reported positive FDA regulatory feedback after a second Type C Meeting on its ATH434 Phase 3 program in Multiple System Atrophy. The agency endorsed key chemistry, manufacturing, and control plans, supporting readiness for a pivotal Phase 3 trial and ongoing manufacturing scale-up.

How does the FDA feedback affect Alterity Therapeutics’ ATH434 Phase 3 plans?

The FDA’s written feedback supports Alterity’s chemistry, manufacturing, and control strategy for ATH434, a potential disease-modifying treatment for Multiple System Atrophy. This alignment helps de-risk technical aspects of the planned Phase 3 trial and eventual commercialization pathway if the drug is ultimately approved.

What is ATH434 and which condition is Alterity Therapeutics targeting?

ATH434 is Alterity Therapeutics’ lead drug candidate being developed for Multiple System Atrophy, a rare and rapidly progressive neurodegenerative disease. The company describes ATH434 as a disease-modifying therapy and is preparing to initiate a pivotal Phase 3 trial after completing supportive Phase 2 studies.

What upcoming FDA interaction is planned for Alterity Therapeutics (ATHE)?

Alterity plans an End-of-Phase 2 meeting with the FDA targeted for mid-2026. This meeting is intended to finalize plans for the ATH434 Phase 3 pivotal program in Multiple System Atrophy, following two earlier Type C Meetings covering clinical and CMC development aspects.

What previous clinical results has Alterity reported for ATH434 in MSA?

Alterity states that ATH434 showed clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 trial in Multiple System Atrophy. The company also reports positive data from an open-label Phase 2 trial in participants with advanced MSA, supporting further development into Phase 3.

Where is Alterity Therapeutics based and what is its broader focus?

Alterity Therapeutics is a clinical-stage biotechnology company based in Melbourne, Australia and San Francisco, USA. It focuses on developing disease-modifying therapies for Multiple System Atrophy and related Parkinsonian disorders and operates a discovery platform generating new compounds for neurodegenerative diseases.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 04/27/2026 - 06:21 AM EDT Learn about SEC filing dates

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 Receives Positive FDA Feedback on CMC Meeting

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 27, 2026

2

Exhibit 99.1

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-up progressing in parallel –

– End-of-Phase 2 meeting with FDA remains on track for mid-2026 –

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 27 April 2026:  Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced it has received positive regulatory feedback following a Type C Meeting with the U.S. Food and Drug Administration (FDA) regarding its planned Phase 3 development program for ATH434 in Multiple System Atrophy (MSA). MSA is a rare, rapidly progressive neurodegenerative disease with no approved disease-modifying treatments.

This second Type C Meeting builds on Alterity’s recent regulatory interactions with the FDA and represents a further step towards readiness for the planned Phase 3 pivotal trial in MSA. Alterity received written feedback supporting its plans related to the chemistry, manufacturing, and control (CMC) elements of the program. The first Type C Meeting, which was announced in March, related to clinical pharmacology and non-clinical development aspects of the program.

“Confirming alignment with the FDA on the chemistry and manufacturing of ATH434 represents another critical step toward initiation of our Phase 3 program,” said David Stamler, M.D., Chief Executive Officer of Alterity. “The FDA endorsed our plans related to the manufacture and testing of ATH434 for use in our Phase 3 trial and ultimately for commercialization, if approved. We continue to advance ATH434 through the necessary steps to initiate our pivotal development program, and we look forward to finalizing our plans with the FDA at an End-of-Phase 2 meeting that remains on track for mid-year 2026.”

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 Company’s 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 Company’s 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 Company’s 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.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EXHIBIT 99.1 12.5 KB