Gain Therapeutics Inc（GANX）資訊與事件GANXGain Therapeutics Inc

Gain Therapeutics Receives FDA Authorization to Advance Rexaceract Clinical Development

"The second quarter marked an important period of execution for Gain, highlighted by FDA authorization of our IND for rexaceract, which positions us to advance into Phase 2 clinical development," said Gene Mack, President and CEO of Gain Therapeutics. "The encouraging biomarker and clinical data generated to date continue to support the potential disease-modifying properties of rexaceract, and we were pleased to further share these findings with the scientific community at the 3rd International GBA1 Meeting. We believe these data further strengthen the therapeutic rationale for rexaceract across both idiopathic and GBA1 Parkinson's disease."

Stock Futures Slightly Lower as Investors Await Middle East News

Stock futures were fractionally lower following Monday's regular session gains as investors await news out of the Middle East. President Trump said the U.S. and Iran will meet to negotiate after days of strikes as the market shifts focus from geopolitics back toward macro data. Investors are watching labor market releases, including the JOLTS report and Thursday's payroll report, for clues on the Federal Reserve path. Markets continue to weigh a resilient economy against concerns that sticky inflation could keep the Fed more restrictive than expected.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER AFTER EARNINGS -AeroVironmentup 20.4%ALSO HIGHER -BTC Digitalup 160.7% after announcing a $28M private placementGain Therapeuticsup 20.2% after receiving FDA clearance of its GT-02287 IND applicationBiomXup 13.7% after filing to sell 7.16M shares of common stock for holdersTradewebup 2.1% after Goldman Sachs upgraded the stock to Buy from NeutralDOWN AFTER EARNINGS -Concentrixdown 22.2%ALSO LOWER -GMEX Roboticsdown 26.4% after announcing a 1-for-9 share consolidationNuvectisdown 19% after announcing a common stock offeringMama's Creationsdown 12.8% after announcing a common stock offering

Gain Therapeutics Receives FDA Approval for GT-02287 IND Application

Gain Therapeutics announced that the FDA has authorized the company's investigational new drug, or IND, application for GT-02287. The FDA's decision will allow initiation of the company's Phase 2 clinical development of GT-02287 in Parkinson's disease with or without a GBA1 mutation in the U.S. Both the Phase 1a and Phase 1b studies of GT-02287 were conducted in Australia. The sites in Australia are expected to also participate in the Phase 2 study along with new sites in the U.S. and select European centers. "We appreciate the FDA's guidance throughout the IND review process and look forward to initiating our Phase 2 study, which is anticipated to occur during 3Q26," said Gene Mack, president and CEO of Gain Therapeutics. "In clinical studies to date, GT-02287 demonstrated target engagement with favorable safety and tolerability. Additionally, recent feedback from trial participants across different clinical sites included anecdotal reports of improvements in smell and taste, balance or gait, and sleep. The FDA's decision is a significant milestone for Gain and we believe it validates the extensive preclinical and clinical work supporting further development of GT-02287. We believe GT-02287 represents the next generation of differentiated therapeutics designed to address the underlying biology of Parkinson's disease and move beyond symptomatic relief to create a new backbone of treatment that can slow or stop disease progression," concluded Mack.