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Alterity Therapeutics (ATHE) FDA Events

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FDA Events for Alterity Therapeutics (ATHE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Alterity Therapeutics (ATHE). Over the past two years, Alterity Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ATH434, ATH434-201, and ATH434-202. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Alterity Therapeutics' Drugs in FDA Review

ATH434 - FDA Regulatory Timeline and Events

ATH434 is a drug developed by Alterity Therapeutics for the following indication: To inhibit the aggregation of pathological proteins implicated in neurodegeneration. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ATH434-201 - FDA Regulatory Timeline and Events

ATH434-201 is a drug developed by Alterity Therapeutics for the following indication: Investigation of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare neurodegenerative disease with no approved treatments to slow or stop its progression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ATH434-202 - FDA Regulatory Timeline and Events

ATH434-202 is a drug developed by Alterity Therapeutics for the following indication: In Multiple System Atrophy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Alterity Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Alterity Therapeutics (ATHE) has reported FDA regulatory activity for the following drugs: ATH434-201, ATH434 and ATH434-202.

The most recent FDA-related event for Alterity Therapeutics occurred on May 12, 2025, involving ATH434. The update was categorized as "Oral presentation," with the company reporting: "Alterity Therapeutics announced that several oral and poster presentations related to Alterity's clinical programs in Multiple System Atrophy (MSA) were featured at the 2025 International MSA Congress."

Current therapies from Alterity Therapeutics in review with the FDA target conditions such as:

  • Investigation of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare neurodegenerative disease with no approved treatments to slow or stop its progression. - ATH434-201
  • To inhibit the aggregation of pathological proteins implicated in neurodegeneration - ATH434
  • In Multiple System Atrophy - ATH434-202

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ATHE) was last updated on 7/10/2025 by MarketBeat.com Staff
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