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MeiraGTx (MGTX) FDA Events

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FDA Events for MeiraGTx (MGTX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by MeiraGTx (MGTX). Over the past two years, MeiraGTx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AAV2-hAQP1, AAV-GAD, and rAAV8.hRKp.AIPL1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

MeiraGTx's Drugs in FDA Review

AAV2-hAQP1 - FDA Regulatory Timeline and Events

AAV2-hAQP1 is a drug developed by MeiraGTx for the following indication: For the Treatment of Grade 2/3 Radiation-Induced Xerostomia. 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.

AAV-GAD - FDA Regulatory Timeline and Events

AAV-GAD is a drug developed by MeiraGTx for the following indication: for the treatment of Parkinson's disease, MGT-GAD-025. 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.

rAAV8.hRKp.AIPL1 - FDA Regulatory Timeline and Events

rAAV8.hRKp.AIPL1 is a drug developed by MeiraGTx for the following indication: For the Treatment of Leber Congenital Amaurosis 4 (LCA4) Retinal 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.

MeiraGTx FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, MeiraGTx (MGTX) has reported FDA regulatory activity for the following drugs: AAV-GAD, rAAV8.hRKp.AIPL1 and AAV2-hAQP1.

The most recent FDA-related event for MeiraGTx occurred on May 9, 2025, involving AAV-GAD. The update was categorized as "Designation Grant," with the company reporting: "MeiraGTx Holdings plc announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV-GAD for the treatment of Parkinson's disease not adequately controlled with anti-Parkinsonian medications."

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

  • for the treatment of Parkinson's disease, MGT-GAD-025. - AAV-GAD
  • For the Treatment of Leber Congenital Amaurosis 4 (LCA4) Retinal Dystrophy - rAAV8.hRKp.AIPL1
  • For the Treatment of Grade 2/3 Radiation-Induced Xerostomia - AAV2-hAQP1

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