Alterity Therapeutics Receives Positive FDA Feedback Following Type C Meeting on ATH434 Phase 3 Program [Yahoo! Finance]
Alterity Therapeutics Limited - American Depositary Shares (ATHE)
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Source: Yahoo! Finance
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. “
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News
- Alterity Therapeutics Appoints Highly Experienced Biotech Executive Ann Cunningham to its Board of DirectorsGlobeNewswire
- Alterity Therapeutics Announces Late-Breaker Oral Presentation at the American Academy of Neurology Annual MeetingGlobeNewswire
- Alterity Therapeutics to Host Virtual KOL Event to Share New Insights on ATH434 for the Treatment of Multiple System AtrophyGlobeNewswire
- Alterity Therapeutics Receives Positive FDA Feedback Following Type C Meeting on ATH434 Phase 3 ProgramGlobeNewswire
- Alterity Therapeutics to Participate in the Bell Potter Healthcare Horizons SummitGlobeNewswire
ATHE
Sec Filings
- 4/17/26 - Form 6-K
- 4/16/26 - Form 6-K
- 4/15/26 - Form 3
- ATHE's page on the SEC website