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. develops allosteric small molecule therapies for neurodegenerative and other difficult-to-treat diseases. The company’s lead candidate, GT-02287, is being developed for Parkinson’s disease with or without a GBA1 mutation and is designed as a brain-penetrant allosteric enzyme modulator of glucocerebrosidase, or GCase.
Recurring news for GANX includes financial results, corporate updates, clinical and biomarker data for GT-02287, FDA and IND-related communications, and scientific presentations at Parkinson’s and neurodegeneration conferences. Company updates also cover the Magellan™ drug discovery platform, preclinical GCase modulator programs such as GT-04686, and pipeline areas including lysosomal storage disorders, metabolic diseases and solid tumors.
Gain Therapeutics (NASDAQ: GANX) presented new preclinical data for GT-02287, their clinical-stage therapy for Parkinson's disease, at the IAPRD 30th World Congress. The study demonstrated GT-02287's neuroprotective properties in cultured rat mesencephalic dopaminergic neurons treated with MPP+, a mitochondrial toxin.
The research showed that GT-02287 improved both lysosomal and mitochondrial function, while reducing α-synuclein aggregation and preventing the release of mitochondrial cytochrome C, a cell death signal. These findings suggest GT-02287's potential as a disease-modifying therapy through its allosteric modulation of GCase and broader neuroprotective effects.
Gain Therapeutics (NASDAQ: GANX), a clinical-stage biotechnology company focused on developing next-generation allosteric small molecule therapies, has announced its participation in The Citizens Life Sciences Conference. The company's President and CEO, Gene Mack, will deliver a presentation on Thursday, May 8, 2025, at 12:00 p.m. EST in New York City.
The event will also feature one-on-one meetings with management, which can be arranged through Citizens representatives. A replay of the presentation will be made available on the Investors and Media section of Gain Therapeutics' website.
Gain Therapeutics (Nasdaq: GANX) has announced an upcoming oral poster presentation at the IAPRD 30th World Congress on Parkinson's Disease and Related Disorders. The event will take place from May 7th-10th in New York City.
The presentation will focus on GT-02287, the company's clinical-stage allosteric GCase modulator designed for treating Parkinson's Disease. Dr. Joanne Taylor, Senior Vice President of Research at Gain Therapeutics, will present findings demonstrating how GT-02287 protects dopaminergic neurons against mitochondrial toxin MPP+.
The presentation is scheduled for Saturday, May 10, 2025, during the Guided Poster Tour session from 8:00-9:00 a.m. EST. This showcase highlights Gain's progress in developing next-generation allosteric small molecule therapies.
Gain Therapeutics (GANX) presented new preclinical data and Phase 1b study design for GT-02287 at AD/PD 2025 Conference. The oral presentation revealed evidence of disease-modifying activity in both GBA1 and idiopathic Parkinson's disease models.
The preclinical data showed GT-02287's ability to rescue motor deficits and prevent complex behavioral deficits, with effects persisting after compound withdrawal. Several biomarkers including α-synuclein, IRE-1, LAMP-1, Miro1, phospho-Tau, and Iba-1 showed statistically significant reductions and maintained lower levels post-treatment.
The ongoing Phase 1b study is evaluating safety, tolerability, and pharmacokinetics in Parkinson's disease patients. An early biomarker analysis is scheduled for Q2 2025, with complete endpoint analysis expected in Q4 2025. The company anticipates completing enrollment by Q2 2025, with Phase 2 planning set to begin in H2 2025.
Gain Therapeutics (NASDAQ: GANX) has announced its upcoming poster presentation at the AD/PD™ 2025 International Conference in Vienna, Austria, scheduled for April 1-5, 2025. The presentation will detail the design of their Phase 1b clinical trial for GT-02287 in Parkinson's disease.
The poster (Number: SHIFT 02-072), titled 'Design of a Phase 1b Study to Evaluate the GCase-Targeting Molecule GT-02287 in GBA1-PD and Sporadic PD,' will be presented by Raffaella Pozzi, Vice President of Clinical Operations at Gain Therapeutics.
Gain Therapeutics (NASDAQ: GANX) has reported its Q4 and full-year 2024 financial results, highlighting significant progress in the development of GT-02287 for Parkinson's disease treatment. The company has initiated dosing in its Phase 1b trial, with first analysis expected in Q2 2025.
Financial highlights for 2024 include:
- Net loss decreased to $20.4 million ($0.89 per share) from $22.3 million in 2023
- R&D expenses decreased to $10.8 million from $11.5 million in 2023
- G&A expenses reduced to $9.6 million from $10.8 million in 2023
- Cash position at $10.4 million as of December 31, 2024
Recent developments include new clinical data showing >50% increase in GCase activity among GT-02287 recipients, favorable safety profiles, and the appointment of Gene Mack as President and CEO. The company plans to submit an IND to FDA by year-end 2025.
Gain Therapeutics (NASDAQ: GANX) has announced the dosing of the first Parkinson's disease (PD) participant in its Phase 1b clinical trial of GT-02287, their lead allosteric small molecule therapy. The open-label, multi-center trial will evaluate safety and tolerability in up to 20 participants with GBA1-PD and idiopathic PD over three months.
The study follows a successful Phase 1 trial in healthy volunteers completed in Q3 2024, where GT-02287 showed favorable safety and tolerability, achieved desired plasma and CNS exposures, and demonstrated over 50% increase in glucocerebrosidase (GCase) activity. Secondary endpoints for the Phase 1b trial include pharmacokinetics, GCase modulation, and biomarker levels in plasma and cerebrospinal fluid.
An interim analysis from the Phase 1b trial is expected by the end of Q2 2025.
Gain Therapeutics (NASDAQ:GANX) has announced the dosing of the first Parkinson's disease (PD) participant in its Phase 1b clinical trial of GT-02287, their lead allosteric small molecule therapy. The trial will evaluate safety and tolerability in up to 20 participants with GBA1-PD and idiopathic PD over three months.
The study follows a successful Phase 1 trial in healthy volunteers completed in Q3 2024, where GT-02287 showed favorable safety and achieved >50% increase in glucocerebrosidase (GCase) activity. Secondary endpoints for the Phase 1b trial include pharmacokinetics, GCase modulation, and biomarker levels in plasma and cerebrospinal fluid.
An interim analysis from the open-label, multi-center trial is expected by the end of Q2 2025.
Gain Therapeutics (GANX) announced that Dr. Joanne Taylor, Senior Vice President of Research, will present their clinical stage lead drug candidate GT-02287 at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Diseases in Vienna, Austria.
The presentation, titled 'Clinical Stage Glucocerebrosidase Modulator, GT-02287, Shows Disease Modifying Potential In Preclinical Models Of Both GBA1 And Idiopathic Parkinson's Disease', will take place on April 5, 2025, at 6:10 PM CET in Hall B during the session on Advances in PD, LBD and MSA 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.