---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-016089"
form_type: "8-K"
ticker: "MGTX"
cik: "0001735438"
company_name: "MeiraGTx Holdings plc"
filed_at: "2024-12-09T23:59:59+00:00"
generated_at: "2026-05-29T05:43:20.445850+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# MeiraGTx granted FDA RMAT designation for AAV2-hAQP1 in Grade 2/3 radiation-induced xerostomia

## Summary
- FDA's RMAT designation includes Fast Track, Breakthrough Therapy benefits and potential Priority Review and accelerated approval.
- Phase 1 AQUAx trial showed significant patient-reported outcomes and saliva production improvements with no serious adverse events.
- Phase 2 AQUAx2 double-blind, placebo-controlled trial is enrolling; FDA agreed Phase 2 may serve as pivotal trial for BLA filing.
- AAV2-hAQP1 previously received FDA Orphan Drug Designation for this indication.

## SEC filing metadata
- accession: 0001558370-24-016089
- form_type: 8-K
- ticker: MGTX
- cik: 0001735438
- company_name: MeiraGTx Holdings plc
- filed_at: 2024-12-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1735438/000155837024016089/0001558370-24-016089-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1735438/000155837024016089/mgtx-20241209x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-016089
- JSON: https://secwatch.observer/filing/0001558370-24-016089.json
- Plain text: https://secwatch.observer/filing/0001558370-24-016089.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.