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Akero Therapeutics (AKRO) FDA Events

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FDA Events for Akero Therapeutics (AKRO)

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

Akero Therapeutics' Drugs in FDA Review

Efruxifermin - FDA Regulatory Timeline and Events

Efruxifermin is a drug developed by Akero Therapeutics for the following indication: Non-alcoholic steatohepatitis (NASH). 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.

Efruxifermin (HARMONY) - FDA Regulatory Timeline and Events

Efruxifermin (HARMONY) is a drug developed by Akero Therapeutics for the following indication: Non-alcoholic steatohepatitis (NASH). 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.

Akero 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, Akero Therapeutics (AKRO) has reported FDA regulatory activity for the following drugs: Efruxifermin and Efruxifermin (HARMONY).

The most recent FDA-related event for Akero Therapeutics occurred on May 10, 2025, involving Efruxifermin (HARMONY). The update was categorized as "Results," with the company reporting: "Akero Therapeutics, Inc. announced results from new analyses of the 96-week Phase 2b HARMONY trial of efruxifermin (EFX) in patients with pre-cirrhotic (F2-F3 fibrosis) metabolic dysfunction-associated steatohepatitis (MASH) in an oral presentation and a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands."

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

  • Non-alcoholic steatohepatitis (NASH) - Efruxifermin
  • Non-alcoholic steatohepatitis (NASH) - Efruxifermin (HARMONY)

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:AKRO) was last updated on 7/10/2025 by MarketBeat.com Staff
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