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Dyne Therapeutics (DYN) FDA Events

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FDA Events for Dyne Therapeutics (DYN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Dyne Therapeutics (DYN). Over the past two years, Dyne Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DYNE-101, DYNE-251, and DYNE-302. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Dyne Therapeutics' Drugs in FDA Review

DYNE-101 - FDA Regulatory Timeline and Events

DYNE-101 is a drug developed by Dyne Therapeutics for the following indication: Designed to enable targeted muscle tissue delivery with the goal of reducing toxic DMPK RNA in the nucleus. 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.

DYNE-251 - FDA Regulatory Timeline and Events

DYNE-251 is a drug developed by Dyne 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.

DYNE-302 - FDA Regulatory Timeline and Events

DYNE-302 is a drug developed by Dyne Therapeutics for the following indication: In Facioscapulohumeral 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.

Dyne 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, Dyne Therapeutics (DYN) has reported FDA regulatory activity for the following drugs: DYNE-251, DYNE-101 and DYNE-302.

The most recent FDA-related event for Dyne Therapeutics occurred on June 17, 2025, involving DYNE-101. The update was categorized as "Designation Grant," with the company reporting: "Dyne Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to DYNE-101 for the treatment of myotonic dystrophy type 1 (DM1)."

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

  • Duchenne Muscular Dystrophy - DYNE-251
  • Designed to enable targeted muscle tissue delivery with the goal of reducing toxic DMPK RNA in the nucleus - DYNE-101
  • In Facioscapulohumeral Muscular Dystrophy - DYNE-302

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