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Investing.com - Gain Therapeutics (NASDAQ:GANX), a clinical-stage biotech company with a market cap of $48.3 million, announced accelerated enrollment in its Phase 1b clinical study evaluating GT-02287 in Parkinson’s disease patients, reaching 16 participants by the end of June, ahead of the original timeline that anticipated 15-20 patients by the third quarter of 2025. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it’s currently experiencing rapid cash burn.
The faster-than-expected enrollment means all participants will reach their 90-day visit in time for biomarker analysis of cerebrospinal fluid samples by the fourth quarter of 2025 instead of the first quarter of 2026. Gain Therapeutics plans to provide full results on 90-day biomarker evidence from all cerebrospinal fluid and blood samples during the fourth quarter of 2025, earlier than initially planned. The company’s next earnings report is scheduled for August 7, 2025, where investors can expect updates on the trial progress.
The company will extend the screening window for participants through the end of July and is planning to approach Australian health authorities to extend the dosing period beyond the currently allowed 90 days. Long-term chronic toxicology studies required to support this extension are near completion, with an update expected before the end of the third quarter of 2025.
Gain Therapeutics believes the extension of the Phase 1b trial will better inform Phase 2 protocol design and planning for early 2026. The upcoming biomarker readout may elucidate GT-02287’s mechanism, which could extend beyond activation of lysosomal GCase to promote neuroprotection.
H.C. Wainwright reiterated a Buy rating on Gain Therapeutics with an $8.00 price target, citing the accelerated timeline and potential significance of the biomarker results in demonstrating the drug’s activity. The stock currently trades below its InvestingPro Fair Value, with analyst targets ranging from $5 to $12 per share. For deeper insights into GANX’s valuation and 10+ additional ProTips, including detailed financial health analysis, check out the comprehensive Pro Research Report available on InvestingPro.
In other recent news, Gain Therapeutics, Inc. announced a significant amendment to its certificate of incorporation, increasing the number of authorized common shares from 50 million to 100 million. This decision was supported by a majority of stockholders during the company’s annual meeting. Additionally, the meeting saw the election of eight directors and the ratification of Ernst & Young AG as the independent registered public accounting firm for the fiscal year ending December 31, 2025. In other developments, Gain Therapeutics reported promising progress on its drug candidate GT-02287, designed as a potential treatment for Parkinson’s disease. The company presented new preclinical evidence at the AD/PD™ 2025 International Conference, showcasing the drug’s ability to alleviate motor and behavioral deficits in animal models. The ongoing Phase 1b clinical study is assessing the safety and pharmacokinetics of GT-02287 in Parkinson’s patients, with early biomarker analysis expected by Q2 2025. The study has received support from several foundations, including The Michael J. Fox Foundation for Parkinson’s Research. Gain Therapeutics aims to use these findings to plan a Phase 2 study later in the year.
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