{"id":954734,"date":"2026-04-27T08:15:53","date_gmt":"2026-04-27T12:15:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/alterity-therapeutics-receives-positive-fda-feedback-following-second-type-c-meeting-on-ath434-phase-3-program-in-multiple-system-atrophy\/"},"modified":"2026-04-27T08:15:53","modified_gmt":"2026-04-27T12:15:53","slug":"alterity-therapeutics-receives-positive-fda-feedback-following-second-type-c-meeting-on-ath434-phase-3-program-in-multiple-system-atrophy","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/alterity-therapeutics-receives-positive-fda-feedback-following-second-type-c-meeting-on-ath434-phase-3-program-in-multiple-system-atrophy\/","title":{"rendered":"Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy"},"content":{"rendered":"
\n\n\n\n\n\n\n\n
\n \u00a0\u2013 Alignment reached on chemistry, manufacturing, and control (CMC) elements of ATH434 Phase 3 development program \u2013<\/em>\n <\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
\n \u2013 Positive feedback supports readiness for Phase 3 initiation with manufacturing scale-up progressing in parallel \u2013<\/em>\n <\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
\n \u2013 End-of-Phase 2 meeting with FDA remains on track for mid-2026 \u2013<\/em>\n <\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n<\/table>\n

MELBOURNE, Australia and SAN FRANCISCO, April 27, 2026 (GLOBE NEWSWIRE) — Alterity Therapeutics<\/u><\/a> (ASX: ATH, NASDAQ: ATHE) (\u201cAlterity\u201d or \u201cthe Company\u201d), 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.<\/p>\n

This second Type C Meeting builds on Alterity\u2019s 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.<\/p>\n

\u201cConfirming alignment with the FDA on the chemistry and manufacturing of ATH434 represents another critical step toward initiation of our Phase 3 program,\u201d said David Stamler, M.D., Chief Executive Officer of Alterity. \u201cThe 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.\u201d<\/p>\n

\n About Alterity Therapeutics Limited <\/strong>\n <\/p>\n

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living\u00a0with 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\u2019s 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\u2019s website at https:\/\/alteritytx.com<\/u><\/a>.<\/p>\n

\n Authorisation & Additional information<\/strong>
\n
This announcement was authorized by the Board of Directors of Alterity Therapeutics Limited.<\/p>\n

\n Contacts:<\/strong>\n <\/p>\n

\n Investors:<\/strong>
\n
Elyse Shapiro
ir@alteritytx.com<\/u><\/a><\/p>\n

Remy Bernarda
Investor Relations Advisory Solutions
ir@alteritytx.com<\/u><\/a>
+1 (415) 203-6386<\/p>\n

\n Media<\/strong>
\n
Casey McDonald
Tiberend Strategic Advisors, Inc.
cmcdonald@tiberend.com<\/u><\/a>
+1 (646) 577-8520<\/p>\n

\n Forward Looking Statements<\/strong>\n <\/p>\n

\n This press release contains \u201cforward-looking statements\u201d within the meaning of section 27A of the Securities Act of 1933 and section<\/em>
\n 21E<\/em>
\n of<\/em>
\n the<\/em>
\n Securities<\/em>
\n Exchange<\/em>
\n Act<\/em>
\n of<\/em>
\n 1934.<\/em>
\n The<\/em>
\n Company<\/em>
\n has<\/em>
\n tried<\/em>
\n to<\/em>
\n identify<\/em>
\n such<\/em>
\n forward-looking<\/em>
\n statements<\/em>
\n by<\/em>
\n use of such words as \u201cexpects,\u201d \u201cintends,\u201d \u201chopes,\u201d \u201canticipates,\u201d \u201cbelieves,\u201d \u201ccould,\u201d \u201cmay,\u201d \u201cevidences\u201d and \u201cestimates,\u201d and other similar expressions, but these words are not the exclusive means of identifying such<\/em>
\n statements.<\/em>\n <\/p>\n

\n Important<\/em>
\n factors<\/em>
\n that<\/em>
\n could<\/em>
\n cause<\/em>
\n actual<\/em>
\n results<\/em>
\n to<\/em>
\n differ<\/em>
\n materially<\/em>
\n from<\/em>
\n those<\/em>
\n indicated<\/em>
\n by<\/em>
\n such<\/em>
\n forward-looking<\/em>
\n statements are<\/em>
\n described<\/em>
\n in<\/em>
\n the<\/em>
\n sections<\/em>
\n titled<\/em>
\n \u201cRisk<\/em>
\n Factors\u201d<\/em>
\n in<\/em>
\n the<\/em>
\n Company\u2019s<\/em>
\n filings<\/em>
\n with<\/em>
\n the<\/em>
\n SEC,<\/em>
\n including<\/em>
\n its<\/em>
\n most<\/em>
\n recent<\/em>
\n Annual<\/em>
\n Report on<\/em>
\n Form<\/em>
\n 20-F<\/em>
\n as<\/em>
\n well<\/em>
\n as<\/em>
\n reports<\/em>
\n on<\/em>
\n Form<\/em>
\n 6-K,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to<\/em>
\n the<\/em>
\n following:<\/em>
\n statements<\/em>
\n relating<\/em>
\n to<\/em>
\n the<\/em>
\n Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s<\/em>
\n drug<\/em>
\n development<\/em>
\n program,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to,<\/em>
\n ATH434,<\/em>
\n and<\/em>
\n any<\/em>
\n other<\/em>
\n statements<\/em>
\n that<\/em>
\n are<\/em>
\n not<\/em>
\n historical facts.<\/em>
\n Such<\/em>
\n statements<\/em>
\n involve<\/em>
\n risks<\/em>
\n and<\/em>
\n uncertainties,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to,<\/em>
\n those<\/em>
\n risks<\/em>
\n and<\/em>
\n uncertainties<\/em>
\n relating<\/em>
\n to<\/em>
\n the difficulties<\/em>
\n or<\/em>
\n delays<\/em>
\n in<\/em>
\n financing,<\/em>
\n development,<\/em>
\n testing,<\/em>
\n regulatory<\/em>
\n approval,<\/em>
\n production<\/em>
\n and<\/em>
\n marketing<\/em>
\n of<\/em>
\n the<\/em>
\n Company\u2019s<\/em>
\n drug components,<\/em>
\n including,<\/em>
\n but<\/em>
\n not<\/em>
\n limited<\/em>
\n to,<\/em>
\n ATH434,<\/em>
\n the<\/em>
\n ability<\/em>
\n of<\/em>
\n the<\/em>
\n Company<\/em>
\n to<\/em>
\n procure<\/em>
\n additional<\/em>
\n future<\/em>
\n sources<\/em>
\n of<\/em>
\n financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited<\/em>
\n to,<\/em>
\n ATH434,<\/em>
\n that<\/em>
\n could<\/em>
\n slow<\/em>
\n or prevent products<\/em>
\n coming<\/em>
\n to<\/em>
\n market,<\/em>
\n the uncertainty<\/em>
\n of obtaining patent protection<\/em>
\n for<\/em>
\n the<\/em>
\n Company’s intellectual<\/em>
\n property<\/em>
\n or<\/em>
\n trade<\/em>
\n secrets, the uncertainty of successfully enforcing the Company\u2019s patent rights and the uncertainty of the Company freedom to operate.<\/em>\n <\/p>\n

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

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

\u00a0\u2013 Alignment reached on chemistry, manufacturing, and control (CMC) elements of ATH434 Phase 3 development program \u2013 \u00a0 \u2013 Positive feedback supports readiness for Phase 3 initiation with manufacturing scale-up progressing in parallel \u2013 \u00a0 \u2013 End-of-Phase 2 meeting with FDA remains on track for mid-2026 \u2013 \u00a0 MELBOURNE, Australia and SAN FRANCISCO, April 27, 2026 (GLOBE NEWSWIRE) — Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (\u201cAlterity\u201d or \u201cthe Company\u201d), 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, … <\/p>\n

Continue reading “Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-954734","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAlterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/alterity-therapeutics-receives-positive-fda-feedback-following-second-type-c-meeting-on-ath434-phase-3-program-in-multiple-system-atrophy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"\u00a0\u2013 Alignment reached on chemistry, manufacturing, and control (CMC) elements of ATH434 Phase 3 development program \u2013 \u00a0 \u2013 Positive feedback supports readiness for Phase 3 initiation with manufacturing scale-up progressing in parallel \u2013 \u00a0 \u2013 End-of-Phase 2 meeting with FDA remains on track for mid-2026 \u2013 \u00a0 MELBOURNE, Australia and SAN FRANCISCO, April 27, 2026 (GLOBE NEWSWIRE) — Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (\u201cAlterity\u201d or \u201cthe Company\u201d), 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). 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/alterity-therapeutics-receives-positive-fda-feedback-following-second-type-c-meeting-on-ath434-phase-3-program-in-multiple-system-atrophy\/","og_locale":"en_US","og_type":"article","og_title":"Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy - Market Newsdesk","og_description":"\u00a0\u2013 Alignment reached on chemistry, manufacturing, and control (CMC) elements of ATH434 Phase 3 development program \u2013 \u00a0 \u2013 Positive feedback supports readiness for Phase 3 initiation with manufacturing scale-up progressing in parallel \u2013 \u00a0 \u2013 End-of-Phase 2 meeting with FDA remains on track for mid-2026 \u2013 \u00a0 MELBOURNE, Australia and SAN FRANCISCO, April 27, 2026 (GLOBE NEWSWIRE) — Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (\u201cAlterity\u201d or \u201cthe Company\u201d), 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). 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