---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-153465"
form_type: "8-K"
ticker: "COYA"
cik: "0001835022"
company_name: "Coya Therapeutics, Inc."
filed_at: "2025-07-01T23:59:59+00:00"
generated_at: "2026-05-18T10:26:52.657934+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Coya re-submits IND for COYA 302 ALS Phase 2 study after FDA request

## Summary
- Re-submitted IND to FDA on June 30, 2025, including requested non-clinical data.
- Previous FDA request on July 14, 2024, for additional non-clinical data.
- Plans to initiate Phase 2 study upon IND acceptance.
- Study: randomized, double-blind, placebo-controlled, 24-week with 24-week OLE, evaluating COYA 302 for ALS.

## SEC filing metadata
- accession: 0001193125-25-153465
- form_type: 8-K
- ticker: COYA
- cik: 0001835022
- company_name: Coya Therapeutics, Inc.
- filed_at: 2025-07-01T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1835022/000119312525153465/0001193125-25-153465-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835022/000119312525153465/d17294d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-153465
- JSON: https://secwatch.observer/filing/0001193125-25-153465.json
- Plain text: https://secwatch.observer/filing/0001193125-25-153465.txt

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