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VYNE Therapeutics (VYNE) FDA Approvals

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VYNE Therapeutics' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by VYNE Therapeutics (VYNE). Over the past two years, VYNE Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Repibresib, VYN201, and VYN202. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Repibresib FDA Regulatory Events

Repibresib is a drug developed by VYNE Therapeutics for the following indication: In nonsegmental vitiligo. 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.

VYN201 FDA Regulatory Timeline and Events

VYN201 is a drug developed by VYNE Therapeutics for the following indication: Vitiligo. 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.

VYN202 FDA Regulatory Timeline and Events

VYN202 is a drug developed by VYNE Therapeutics for the following indication: A Novel BD2-Selective BET Inhibitor. 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.

VYNE Therapeutics FDA Events - Frequently Asked Questions

In the past two years, VYNE Therapeutics (VYNE) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, VYNE Therapeutics (VYNE) has reported FDA regulatory activity for the following drugs: VYN202, VYN201 and Repibresib.

The most recent FDA-related event for VYNE Therapeutics occurred on July 30, 2025, involving Repibresib. The update was categorized as "Top-line results," with the company reporting: "VYNE Therapeutics Inc. announced topline results from its Phase 2b trial evaluating Repibresib gel in nonsegmental vitiligo."

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

  • A Novel BD2-Selective BET Inhibitor - VYN202
  • Vitiligo - VYN201
  • In nonsegmental vitiligo. - Repibresib

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:VYNE) was last updated on 8/2/2025 by MarketBeat.com Staff
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