---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-039410"
form_type: "8-K"
ticker: "PTIX"
cik: "0001022899"
company_name: "Protagenic Therapeutics, Inc.new"
filed_at: "2026-08-20T15:26:06+00:00"
generated_at: "2026-08-20T15:27:06.790969+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Protagenic Therapeutics gets FDA pre-IND feedback with no objections for PT00114 GAD Phase 1 plan

## Summary
- FDA identified no clinical hold issues and raised no objection to the three-part Phase 1 design, dose-escalation, and safety review governance.
- FDA deemed the potency/comparability strategy, CMC, and nonclinical packages reasonable to support an IND submission.
- Company plans to submit the IND before end of 2026 (Q4 2026); targets first patient dosing in first half of 2027.
- PT00114 completed ex-US Phase 1 single- and multiple-ascending-dose studies, well tolerated with no serious adverse events.
- GAD affects ~6.8M U.S. adults; no new medicine approved specifically for GAD in nearly two decades.

## SEC filing metadata
- accession: 0001493152-26-039410
- form_type: 8-K
- ticker: PTIX
- cik: 0001022899
- company_name: Protagenic Therapeutics, Inc.new
- filed_at: 2026-08-20T15:26:06+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1022899/000149315226039410/0001493152-26-039410-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1022899/000149315226039410/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-039410
- JSON: https://secwatch.observer/filing/0001493152-26-039410.json
- Plain text: https://secwatch.observer/filing/0001493152-26-039410.txt

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