Free Trial

Applied Therapeutics (APLT) FDA Events

Applied Therapeutics logo
$0.40 +0.03 (+7.05%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$0.39 -0.01 (-2.03%)
As of 04:56 AM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Applied Therapeutics (APLT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Applied Therapeutics (APLT). Over the past two years, Applied Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AT-007, AT-007, and govorestat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Applied Therapeutics' Drugs in FDA Review

AT-007 - FDA Regulatory Timeline and Events

AT-007 is a drug developed by Applied Therapeutics for the following indication: Galactosemia. 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.

AT-007 (SORD) - FDA Regulatory Timeline and Events

AT-007 (SORD) is a drug developed by Applied Therapeutics for the following indication: SORD Deficiency. 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.

govorestat - FDA Regulatory Timeline and Events

govorestat is a drug developed by Applied Therapeutics for the following indication: For the Treatment of Classic Galactosemia. 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.

Applied 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, Applied Therapeutics (APLT) has reported FDA regulatory activity for the following drugs: govorestat, AT-007 (SORD) and AT-007.

The most recent FDA-related event for Applied Therapeutics occurred on May 18, 2025, involving AT-007 (SORD). The update was categorized as "Results," with the company reporting: "Applied Therapeutics, Inc. today presented full 12-month clinical results and new topline data from 18 and 24 months from the INSPIRE Phase 2/3 trial of govorestat (AT-007) for the treatment of Sorbitol Dehydrogenase (SORD) Deficiency, a subtype of Charcot-Marie-Tooth (CMT) disease, in an oral presentation at the Peripheral Nerve Society (PNS) 2025 Annual Meeting, being held May 17-20, 2025 in Edinburgh, Scotland."

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

  • For the Treatment of Classic Galactosemia - govorestat
  • SORD Deficiency - AT-007 (SORD)
  • Galactosemia - AT-007

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:APLT) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners