---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-011478"
form_type: "8-K"
ticker: "MGTX"
cik: "0001735438"
company_name: "MeiraGTx Holdings plc"
filed_at: "2025-08-14T23:59:59+00:00"
generated_at: "2026-05-17T13:18:13.377819+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# MeiraGTx Q2 net loss narrows to $38.8M; FDA alignment on RIX pivotal study, RMAT for Parkinson's

## Summary
- Net loss $38.8M ($0.48/sh) vs $48.6M ($0.76/sh) in Q2 2024; cash $32.2M at June 30, 2025.
- FDA aligns on AAV-hAQP1 Phase 2 AQUAx2 as potentially pivotal for BLA in radiation-induced xerostomia; enrollment target Q4 2025, data late 2026.
- FDA grants RMAT designation for AAV-GAD in Parkinson's; clean GCP inspection; Phase 3 study planned in 2025.
- Received $23M of $200M from Hologen collaboration; forming JV Hologen Neuro AI with up to $230M funding for AAV-GAD development.
- Preparing MAA in UK and BLA in US for AAV-AIPL1 in LCA4; Lancet publication shows all 11 treated children now able to see.

## SEC filing metadata
- accession: 0001558370-25-011478
- form_type: 8-K
- ticker: MGTX
- cik: 0001735438
- company_name: MeiraGTx Holdings plc
- filed_at: 2025-08-14T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1735438/000155837025011478/0001558370-25-011478-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1735438/000155837025011478/mgtx-20250814x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-011478
- JSON: https://secwatch.observer/filing/0001558370-25-011478.json
- Plain text: https://secwatch.observer/filing/0001558370-25-011478.txt

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