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Attovia Therapeutics (ATTO) FDA Approvals

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Attovia Therapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Attovia Therapeutics (ATTO). Over the past two years, Attovia Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ATTO-1310. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

ATTO-1310 FDA Regulatory Events

ATTO-1310 is a drug developed by Attovia Therapeutics for the following indication: in patients with high-itch atopic dermatitis (AD) or with chronic pruritus. 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.

Attovia Therapeutics FDA Events - Frequently Asked Questions

As of now, Attovia Therapeutics (ATTO) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Attovia Therapeutics (ATTO) has reported FDA regulatory activity for ATTO-1310.

The most recent FDA-related event for Attovia Therapeutics occurred on September 28, 2026, involving ATTO-1310. The update was categorized as "Data Presentation," with the company reporting: "Attovia Therapeutics, Inc. announced that it will present new clinical, translational, and preclinical data across its pipeline at the European Academy of Dermatology and Venereology (EADV) Congress 2026 and the Fall Clinical Dermatology Conference (FCD) 2026."

Currently, Attovia Therapeutics has one therapy (ATTO-1310) targeting the following condition: in patients with high-itch atopic dermatitis (AD) or with chronic pruritus.

  • 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

FDA progress for NASDAQ:ATTO last updated on 9/29/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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