Welcome to our dedicated page for Gain Therapeutics news (Ticker: GANX), a resource for investors and traders seeking the latest updates and insights on Gain Therapeutics stock.
Gain Therapeutics, Inc. (Nasdaq: GANX) is a clinical-stage biotechnology company whose news flow is closely tied to the development of its lead drug candidate, GT-02287, and to progress in its broader allosteric small molecule pipeline. The company focuses on next generation allosteric therapies targeting neurodegenerative diseases, rare genetic disorders and oncology, with a primary emphasis on Parkinson’s disease.
News about Gain Therapeutics frequently covers clinical milestones for GT-02287, including updates from its Phase 1 and Phase 1b studies in people with Parkinson’s disease with or without a GBA1 mutation. Press releases have detailed safety and tolerability findings, exploratory biomarker data such as reductions in glucosylsphingosine (GluSph) in cerebrospinal fluid, and observations related to Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) scores. These items provide insight into how the company interprets GT-02287’s potential disease-modifying effects and mechanism of action.
Investors and observers can also expect regular announcements on preclinical research and scientific presentations. Gain Therapeutics reports data from preclinical models that explore GCase modulation, mitochondrial and lysosomal health, and neuroprotection in Parkinson’s disease. Poster presentations at scientific meetings, such as Neuroscience conferences and Parkinson’s-focused congresses, are common subjects of the company’s news releases.
Additional news items include corporate updates and financial disclosures, such as quarterly financial results, capital raises, changes in board composition, and shareholder meeting outcomes. The company also issues notices about participation in investor conferences, key opinion leader (KOL) events, and webinars that discuss biomarkers, clinical endpoints and emerging data from GT-02287 studies.
For readers following GANX, the news page provides a centralized view of clinical trial progress, scientific data, regulatory and corporate developments, and event participation related to Gain Therapeutics’ efforts in allosteric small molecule drug development.
Gain Therapeutics (NASDAQ: GANX) provided a shareholder update outlining key milestones for 2025, focusing on the clinical development of GT-02287, a potential disease-modifying therapy for Parkinson's disease. The company received approval to initiate a Phase 1b clinical trial following successful completion of healthy volunteer studies that showed a 53% increase in GCase activity.
The Phase 1b trial will enroll 15-20 individuals with GBA1 or idiopathic Parkinson's disease, with enrollment updates expected by Q1 2025 and interim analysis guidance in Q2 2025. The company held a productive pre-IND meeting with FDA in December 2024, with no significant regulatory hurdles identified.
As of September 30, 2024, the company had approximately $12M in cash, expected to be sufficient through the interim analysis of the Phase 1b trial. The company is exploring potential licensing partnerships and financing options while preparing for Phase 2 studies anticipated in H2 2025.
Gain Therapeutics (Nasdaq: GANX), a clinical-stage biotechnology company focused on developing next-generation allosteric small molecule therapies, has announced its participation in two major investor conferences in February 2025.
CEO Gene Mack will deliver corporate presentations at:
- The BIO CEO & Investor Conference on February 11 at 1:15pm ET in the Plymouth Room at The New York Marriott Marquis
- The Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12 at 10:40am ET (virtual presentation)
Registered attendees can schedule one-on-one meetings with Gain management through the respective conference platforms. Investors unable to attend can request meetings by contacting ir@gaintherapeutics.com.
Gain Therapeutics, a clinical-stage biotechnology company, announced the formation of a Clinical Advisory Board (CAB) to support the development of its lead drug candidate, GT-02287, for Parkinson's disease. The CAB includes experts in trial design, genetics, and biomarkers and will assist in progressing GT-02287 through potential Phase 2 and Phase 3 clinical trials.
CEO Gene Mack emphasized the strategic importance of this step, expressing confidence in the CAB's collective expertise to advance the treatment. Key members include:
- Karl Kieburtz, M.D., M.P.H., a neurology professor with extensive experience in clinical trials and advisory roles.
- Roy Alcalay, M.D., M.S., Chief of the Movement Disorders Division at Tel Aviv Sourasky Medical Center, focusing on biomarkers and genetics.
- Samuel Broder, M.D., former Director of the National Cancer Institute, known for his work in developing anti-cancer agents and HIV treatments.
- Wilma D.J. Van de Berg, Ph.D., a senior translational neuroscientist specializing in neuropathology and biomarker research.
Gain Therapeutics (NASDAQ: GANX) has appointed Gene Mack as permanent President and Chief Executive Officer, effective January 6, 2025. Mack, who has served as CFO since April 2024 and interim CEO since June 2024, has also joined the Company's Board of Directors. Additionally, Gianluca Fuggetta has been promoted to Senior Vice President, Finance and Principal Financial Officer.
Mack brings over 25 years of life sciences experience spanning clinical research, financing, capital markets, investing, corporate strategy, and business development. His appointment comes as the company advances its lead candidate, GT-02287, through an ongoing Phase 1b trial in Parkinson's Disease during the first half of 2025, with potential Phase 2 activities planned for the second half of 2025.
Prior to joining Gain, Mack served as CFO at Imcyse SA (2021-2023) and OncoC4, following various CFO roles at development and commercial-stage biopharmaceutical companies. He also has experience as a senior publishing analyst covering biotechnology at investment banks including Gruntal & Co, Lazard, Mizuho, and HSBC.
Gain Therapeutics (NASDAQ: GANX) has received approval to initiate a Phase 1b clinical trial in Australia for GT-02287, its lead candidate for treating Parkinson's disease (PD). The trial follows a successful Phase 1 study where GT-02287 demonstrated safety, tolerability, and >50% increase in GCase activity. The Phase 1b trial will assess safety and tolerability in PD patients over three months of dosing at 13.5 mg/kg/day, along with biomarker evaluation.
The company expects to complete enrollment in spring 2025, with data anticipated by mid-2025. The trial will be conducted across seven Australian sites, focusing on both GBA1 and idiopathic Parkinson's disease patients. Secondary endpoints include pharmacokinetics, GCase modulation, and substrate levels in plasma and cerebrospinal fluid.
Gain Therapeutics (Nasdaq: GANX), a clinical-stage biotechnology company, has announced its participation in Biotech Showcase 2025. Gene Mack, the Company's Chief Financial Officer and Interim Chief Executive Officer, will deliver a corporate presentation featuring their lead drug candidate GT-02287 and the Magellan Drug Discovery Platform.
The presentation is scheduled for Tuesday, January 14, at 9:30am PT in the Yosemite A track at the Hilton San Francisco Union Square. The Biotech Showcase, jointly produced by Demy-Colton and EBD Group, is an investor-focused conference that facilitates networking between executives and investors to promote therapeutic development and investment opportunities.
Gain Therapeutics (GANX) reported Q3 2024 financial results and provided updates on GT-02287, its lead candidate for Parkinson's disease treatment. The Phase 1 study showed a 53% increase in GCase activity with favorable safety in healthy volunteers. The company plans to initiate a Phase 1b trial in Parkinson's patients by end of 2024. Financial highlights include R&D expenses of $2.6M (up $0.3M YoY), G&A expenses of $1.8M (down $0.7M YoY), and cash position of $12M as of September 30, 2024. Net loss was $0.17 per share compared to $0.37 in Q3 2023.
Gain Therapeutics (NASDAQ: GANX) presented data at the 36th EORTC-NCI-AACR Symposium showcasing their allosteric inhibitor GT-03842, identified through their Magellan Drug Discovery Platform. The compound effectively targets and inhibits DDR2 phosphorylation, a protein associated with various cancer types and tumor progression. GT-03842 demonstrated dose-dependent inhibition in both HEK293 cells and a metastatic breast cancer model. The compound's unique mechanism, targeting outside the kinase domain, suggests potential advantages over traditional kinase inhibitors, including enhanced selectivity and reduced resistance.
Gain Therapeutics (Nasdaq: GANX) announced a poster presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, from October 23-25, 2024. The poster will showcase the use of Gain's Magellan platform to discover novel allosteric discoidin domain receptor 2 (DDR2) inhibitors.
DDR2 is implicated in various cancer types and plays a important role in tumor progression. Allosteric small molecule inhibitors have the potential to overcome resistance and offer improved selectivity and safety compared to traditional kinase inhibitors. The presentation, titled 'Identification of allosteric inhibitors targeting Discoidin Domain Receptor 2 (DDR2)', will be given by Sara Cano-Crespo, Ph.D., from Gain Therapeutics during the Molecular Targeted Agents poster session on October 23, 2024, at 11am CEST.
Gain Therapeutics, Inc. (Nasdaq: GANX) has announced that its Chief Medical Officer, Jonas Hannestad, M.D., Ph.D., will present at the Michael J. Fox Foundation's 16th Annual Parkinson's Disease Therapeutics Conference on October 17, 2024, in New York City. The presentation will focus on the company's clinical stage lead drug candidate GT-02287, which is being developed for the treatment of Parkinson's disease.
Dr. Hannestad's oral presentation, titled 'Brain-penetrant small molecule GT-02287 is well-tolerated in healthy volunteers, shows GCase target engagement, and achieves therapeutic exposures shown to modulate PD pathobiology in preclinical models,' will be part of the conference's first session, 'Progress in the Therapeutics Pipeline.' The presentation will include Phase 1 data for GT-02287 and recent preclinical findings.
The Parkinson's Disease Therapeutics Conference is the only global event focused exclusively on Parkinson's disease drug development, bringing together 300 research and clinical development professionals from academia and industry to showcase innovative research from MJFF's portfolio.
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