Alignment reached on key elements of ATH434 Phase 3 development program
MELBOURNE, Australia and SAN FRANCISCO, March 30, 2026 (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 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).
The Type C Meeting is part of a multidisciplinary strategy to seek alignment with the FDA on readiness to initiate a Phase 3 pivotal trial in MSA. Alterity received written feedback supporting its plans related to the clinical pharmacology and non-clinical development elements of the program.
“This meeting confirms alignment with the FDA in two key disciplines and represents an important step toward initiation of the Phase 3 program,” said David Stamler, M.D., Chief Executive Officer of Alterity. “In addition, we will also be seeking agreement with the FDA on Chemistry, Manufacturing, and Controls (CMC) and the Phase 3 trial design. Today’s favorable outcome sets the stage for our future discussions, culminating in 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 www.alteritytherapeutics.com.
Authorisation & Additional information
This announcement was authorized by the Board of Alterity Therapeutics Limited.
Contacts:
Investors:
Tara Speranza
Head of Investor Relations and Communications
[email protected]
Remy Bernarda
Investor Relations Advisory Solutions
[email protected]
+1 (415) 203-6386
Media
Casey McDonald
Tiberend Strategic Advisors, Inc.
[email protected]
+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.
