---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-178809"
form_type: "8-K"
ticker: "COYA"
cik: "0001835022"
company_name: "Coya Therapeutics, Inc."
filed_at: "2024-07-15T23:59:59+00:00"
generated_at: "2026-05-31T20:49:16.858339+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Coya Therapeutics FDA requires additional non-clinical data before initiating Phase 2 ALS trial for COYA 302

## Summary
- Submitted IND for Phase 2 double-blind, placebo-controlled study of COYA 302 in ALS on June 14, 2024.
- FDA notified on July 12, 2024 that additional non-clinical data is required prior to study initiation.
- FDA will provide details on required data within 30 days.
- Study was designed as 24-week treatment phase with 24-week open-label extension.
- Regulatory delay may push back clinical timeline for COYA 302.

## SEC filing metadata
- accession: 0001193125-24-178809
- form_type: 8-K
- ticker: COYA
- cik: 0001835022
- company_name: Coya Therapeutics, Inc.
- filed_at: 2024-07-15T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1835022/000119312524178809/0001193125-24-178809-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835022/000119312524178809/d762748d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-178809
- JSON: https://secwatch.observer/filing/0001193125-24-178809.json
- Plain text: https://secwatch.observer/filing/0001193125-24-178809.txt

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