secwatch.observer — SEC 8-K summary
======================================

Issuer:     Protagenic Therapeutics, Inc.new (PTIX)
CIK:        0001022899
Form:       8-K
Filed at:   2026-08-20T15:26:06+00:00
Accession:  0001493152-26-039410
Event type: regulatory
Sentiment:  positive
Materiality: 0.55
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1022899/000149315226039410/0001493152-26-039410-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1022899/000149315226039410/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-039410

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer