---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-168115"
form_type: "8-K"
ticker: "COYA"
cik: "0001835022"
company_name: "Coya Therapeutics, Inc."
filed_at: "2025-07-29T23:59:59+00:00"
generated_at: "2026-05-17T23:47:20.076733+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.45
calibrated_materiality_score: 0.45
confidence: "high"
source: SEC EDGAR
---

# FDA delays IND review for COYA 302 ALS trial due to workload; decision expected by Aug 29, 2025

## Summary
- Coya submitted IND for Phase 2 ALS study of COYA 302 on June 30, 2025.
- FDA informed Coya on July 29, 2025, that it cannot meet initial July 30 review goal due to workload and resource constraints.
- FDA expects to provide IND decision no later than August 29, 2025.
- Delay affects timeline for starting the planned 24-week placebo-controlled study with 24-week OLE.

## SEC filing metadata
- accession: 0001193125-25-168115
- form_type: 8-K
- ticker: COYA
- cik: 0001835022
- company_name: Coya Therapeutics, Inc.
- filed_at: 2025-07-29T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.45
- calibrated_materiality_score: 0.45
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1835022/000119312525168115/0001193125-25-168115-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835022/000119312525168115/d14950d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-168115
- JSON: https://secwatch.observer/filing/0001193125-25-168115.json
- Plain text: https://secwatch.observer/filing/0001193125-25-168115.txt

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