Gain Therapeutics, Inc. GANX
Gain Therapeutics, Inc. (Nasdaq: GANX) is a CNS/neurology/psychiatry drug developer. Its lead program, Rexaceract (GT-02287), is in Phase 1 for Parkinson's disease with or without GBA1 mutation. Its next catalyst on record is rexaceract: Company expects to submit Phase 2 protocol to FDA in coming weeks and initiate Phase 2 trial in Q1 2027. (Q1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: rexaceract — Company expects to submit Phase 2 protocol to FDA in coming weeks and initiate Phase 2 trial in Q1 2027. (Q1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Rexaceract (GT-02287) | Parkinson's disease (Phase 1b Part 2 extension ongoing; Phase 2a planned) | small molecule | Phase 1 |
| GT-04686 | Allosteric GCase modulator series (GBA1-related disease) | small molecule | Pre-clinical |
Recent results and decisions
- Oct 1, 2026positive Rexaceract Phase 1b open-label extension data shows stabilization of MDS-UPDRS motor scores over 12 months in Parkinson's disease patients.
MDS-UPDRS motor scores were stable over the 12-month study period with rexaceract, demonstrating no clinically meaningful progression of motor symptoms on the MDS-UPDRS Parts II and III.
Filing - Nov 12, 2025positive Initial Phase 1b data (MDS conference, Oct 2025): MDS-UPDRS Part II/III improvement after 90 days in first nine participants, no treatment-emergent serious AEs; PK consistent across 14 sampled.
Several participants experienced an improvement in their UPDRS Part II and III scores after 90 days of dosing with GT-02287 while mean Part I scores remained unchanged.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 1 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.