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Entrada Therapeutics (TRDA) FDA Events

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FDA Events for Entrada Therapeutics (TRDA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Entrada Therapeutics (TRDA). Over the past two years, Entrada Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ELEVATE-44-201, ENTR-601-44, ENTR-601-44-101, and ENTR-601-45. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Entrada Therapeutics' Drugs in FDA Review

ELEVATE-44-201 - FDA Regulatory Timeline and Events

ELEVATE-44-201 is a drug developed by Entrada Therapeutics for the following indication: For Duchenne Muscular Dystrophy. 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.

ENTR-601-44 - FDA Regulatory Timeline and Events

ENTR-601-44 is a drug developed by Entrada Therapeutics for the following indication: Duchenne muscular dystrophy. 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.

ENTR-601-44-101 - FDA Regulatory Timeline and Events

ENTR-601-44-101 is a drug developed by Entrada Therapeutics for the following indication: For Duchenne Muscular Dystrophy. 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.

ENTR-601-45 - FDA Regulatory Timeline and Events

ENTR-601-45 is a drug developed by Entrada Therapeutics for the following indication: In patients with Duchenne who are exon 45 skipping amenable. 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.

Entrada 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, Entrada Therapeutics (TRDA) has reported FDA regulatory activity for the following drugs: ELEVATE-44-201, ENTR-601-45, ENTR-601-44-101 and ENTR-601-44.

The most recent FDA-related event for Entrada Therapeutics occurred on May 28, 2025, involving ENTR-601-45. The update was categorized as "Authorization," with the company reporting: "Entrada Therapeutics, Inc. announced it has received authorization from the Health Authorities and Ethics Committees of multiple countries under the European Union Clinical Trial Regulation (EU-CTR) to initiate ELEVATE-45-201, a Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-45 in patients living with Duchenne muscular dystrophy (DMD) who are amenable to exon 45 skipping."

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

  • For Duchenne Muscular Dystrophy - ELEVATE-44-201
  • In patients with Duchenne who are exon 45 skipping amenable - ENTR-601-45
  • For Duchenne Muscular Dystrophy - ENTR-601-44-101
  • Duchenne muscular dystrophy - ENTR-601-44

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