secwatch.observer — SEC 8-K summary
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Issuer:     Gain Therapeutics, Inc. (GANX)
CIK:        0001819411
Form:       8-K
Filed at:   2026-10-01T13:16:02+00:00
Accession:  0001104659-26-112624
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Gain Therapeutics' rexaceract holds MDS-UPDRS scores stable over 12 months; Phase 2 in Parkinson's set for Q1 2027
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- 12 of 13 evaluable patients completed the full 12-month rexaceract dosing in the Phase 1b open-label extension; one remaining participant finishes in November 2026.
- MDS-UPDRS Parts II+III motor scores remained stable over 360 days, versus the ~6-point annual increase generally accepted as clinically meaningful PD progression.
- Company expects to submit a new Phase 2 protocol to the FDA in coming weeks and initiate the Phase 2 trial in people with Parkinson's disease in Q1 2027.
- No new safety signals over 12 months; a lower incidence of treatment-emergent adverse events occurred in the nine-month extension (Part 2) than in the initial three-month dosing (Part 1).
- High and low baseline CSF GluSph patients both showed stable motor scores at 12 months; high-baseline patients had large GluSph drops toward healthy levels by day 90 and faster response.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1819411/000110465926112624/0001104659-26-112624-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1819411/000110465926112624/tm2626750d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-112624

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