---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-172488"
form_type: "8-K"
ticker: "QTTB"
cik: "0001661998"
company_name: "Q32 Bio Inc."
filed_at: "2022-06-13T23:59:59+00:00"
generated_at: "2026-06-25T02:23:27.725990+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Homology's pheNIX gene therapy trial for HMI-102 in PKU

## Summary
- FDA lifted clinical hold on pheNIX trial (HMI-102) for phenylketonuria; company resolved all issues from March 17, 2022 hold.
- Clinical hold related to elevated liver function tests, all resolved without hospitalizations.
- Protocol changes include steroid-sparing immunosuppression with tacrolimus and shorter steroid course.
- Company plans to provide program update in fall 2022.

## SEC filing metadata
- accession: 0001193125-22-172488
- form_type: 8-K
- ticker: QTTB
- cik: 0001661998
- company_name: Q32 Bio Inc.
- filed_at: 2022-06-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1661998/000119312522172488/0001193125-22-172488-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1661998/000119312522172488/d358045d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-172488
- JSON: https://secwatch.observer/filing/0001193125-22-172488.json
- Plain text: https://secwatch.observer/filing/0001193125-22-172488.txt

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