---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-028064"
form_type: "8-K"
ticker: "QCLS"
cik: "0001321834"
company_name: "Q/C TECHNOLOGIES, INC."
filed_at: "2023-08-14T23:59:59+00:00"
generated_at: "2026-06-11T10:22:54.968498+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA accepts MyMD IND for Phase 2 study of oral TNF-α inhibitor MYMD-1 in rheumatoid arthritis

## Summary
- FDA acceptance allows Phase 2 trial in RA; MyMD will discuss timing with CRO IQVIA.
- MYMD-1 is an oral TNF-α inhibitor; existing TNF-α inhibitors require injection or infusion.
- Prior Phase 2 sarcopenia/frailty data showed statistical reduction in TNF-α, IL-6, sTNFR1.
- Company claims MYMD-1 blocks both TNF-α and IL-6, differentiating from current RA treatments.
- Plans to initiate Phase 3 trials in sarcopenia; if approved, first FDA-approved drug for sarcopenia.

## SEC filing metadata
- accession: 0001493152-23-028064
- form_type: 8-K
- ticker: QCLS
- cik: 0001321834
- company_name: Q/C TECHNOLOGIES, INC.
- filed_at: 2023-08-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1321834/000149315223028064/0001493152-23-028064-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1321834/000149315223028064/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-028064
- JSON: https://secwatch.observer/filing/0001493152-23-028064.json
- Plain text: https://secwatch.observer/filing/0001493152-23-028064.txt

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