---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-078848"
form_type: "8-K"
ticker: "GANX"
cik: "0001819411"
company_name: "Gain Therapeutics, Inc."
filed_at: "2026-06-29T20:21:05+00:00"
generated_at: "2026-06-29T20:22:25.212349+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA authorizes IND for Gain Therapeutics' GT-02287, permitting Phase 2 Parkinson's study

## Summary
- FDA authorized IND for GT-02287, enabling Phase 2 clinical development in Parkinson's disease with or without GBA1 mutation.
- Phase 2a study of oral GT-02287 in early Parkinson's patients planned; sites in U.S., Australia, and Europe.
- Phase 2a initiation expected in Q3 2026; Phase 1a/b were conducted in Australia.
- FDA clearance is a key regulatory milestone for Gain Therapeutics' lead candidate.

## SEC filing metadata
- accession: 0001104659-26-078848
- form_type: 8-K
- ticker: GANX
- cik: 0001819411
- company_name: Gain Therapeutics, Inc.
- filed_at: 2026-06-29T20:21:05+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1819411/000110465926078848/0001104659-26-078848-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1819411/000110465926078848/tm2619336d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-078848
- JSON: https://secwatch.observer/filing/0001104659-26-078848.json
- Plain text: https://secwatch.observer/filing/0001104659-26-078848.txt

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