GAIN THERAP.INC DL-,0001

Gain Therapeutics received IND approval from the FDA and intends to start a Phase 2 study with the oral drug Rexaceract for the treatment of Parkinson’s disease in the third quarter of 2026. The study will recruit early Parkinson’s patients in the US, Australia and Europe. In the ongoing Phase 1b extension all 16 participants remained through day 150; after 90 days Rexaceract produced an average 81% reduction of glucosylsphingosine in cerebrospinal fluid in patients with elevated baseline values. Gain announced management promotions and reported cash of around $16.5 million, expected to fund operations through the second quarter of 2027. » Więcej na de.investing.com

The FDA has approved the Investigational New Drug (IND) application for GT-02287, allowing Gain Therapeutics to start a Phase 2 study in the US, expected in Q3 2026. The decision is based on positive Phase 1 data with biomarker results, clinical signals and a favorable safety profile. GT-02287 is an orally administered, brain-penetrant small molecule designed to restore glucocerebrosidase function and is being developed for patients with and without a GBA1 mutation. The stock rose sharply in after-hours trading (around 21.2%). » Więcej na de.investing.com

The FDA has approved the IND application for Gain Therapeutics' GT-02287, allowing the company to start a Phase 2a study in the U.S. in Q3 2026. The approval follows completed Phase 1a/1b studies in Australia; the planned trial will enroll early Parkinson’s patients in the U.S., Australia and Europe. GT-02287 is an oral, brain-penetrant small molecule designed to restore lysosomal glucocerebrosidase function and to act in Parkinson’s with or without a GBA1 mutation. Biomarker and clinical data from the Phase 1b showed strong reductions in glucosylsphingosine and improvements in MDS‑UPDRS scores; analysts cite price targets of $5 to $8, while the stock has fallen about 46% year-to-date. » Więcej na de.investing.com