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Press Releases

Spinogenix Announces Open Enrollment for Phase 2 US Trial Following FDA Clearance of IND Application for SPG302, the First Synaptic Regenerative Therapy for Schizophrenia

Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain Activity

FDA Grants Fast Track Designation to Spinogenix’s SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism

Spinogenix Appoints American Football Hall of Famer and Health Advocate Steve Young to its Board of Directors

Spinogenix Announces Launch of Glaucoma Program and Addition of World-Renowned Expert Dr. Robert Weinreb to its Science Advisory Board

Spinogenix Announces Launch of a Phase 2 Clinical Trial Evaluating SPG302 for the Treatment of Schizophrenia

Spinogenix Announces Open Enrollment for Phase 2 Study Evaluating SPG302 for the Treatment of Alzheimer’s Disease

Spinogenix Announces Enrollment is Open for its Phase 2 Clinical Trial of SPG601 Fragile X syndrome

Spinogenix Announces Approval from the Australia Human Research Ethics Committee to Initiate a Phase 2 Human Clinical Trial of SPG302 for the Treatment of Alzheimer’s Disease

Spinogenix Announces FDA Clearance of IND Application for SPG302, a Novel Therapy for the Treatment of ALS

Spinogenix Announces U.S. FDA Orphan Drug Designation Granted to SPG601 for the Treatment of Fragile X syndrome

Spinogenix Announces U.S. FDA Approval of its Investigational New DrugApplication for its Phase 2a Clinical Trial of SPG601 for Fragile X syndrome

Spinogenix Announces Second Grant Award from U.S. Department of Defense to Further Advance SPG302, the First Synaptic Regenerative Drug to Treat Amyotrophic Lateral Sclerosis (ALS)

Spinogenix Awarded $3 Million NIH Grant to Support Continued Development of SPG302, the First Synaptic Regenerative Therapeutic for Alzheimer’s Disease

Spinogenix Receives Approval from the Australia Human Research Ethics Committee to Initiate a Phase 1 Human Clinical Trial of SPG302, a Novel Regenerative Drug for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Spinogenix Granted FDA Orphan Drug Designation for SPG302 for the Treatment of Amyotrophic Lateral Sclerosis

Spinogenix Announces Grant by U.S. Department of Defense to Advance Novel Drug Candidate in Amyotrophic Lateral Sclerosis (ALS)

In the News

SPG302: A Synaptic Regenerative Treatment Option for Schizophrenia

SPG601 found to reduce measure of abnormal brain activity in fragile X

FDA Grants Fast Track Designation to Spinogenix’s SPG601 for Treatment of FXS

FDA Designation for SPG601 Highlights New Hope for FXS Treatment

Novel BK Channel Activator Fast Tracked for Fragile X Syndrome

Personalized medicine; astroglia organoids; fast track for fragile X drug

Spinogenix’s SPG601 Receives FDA Fast Track Designation for Fragile X Syndrome

FDA grants fast-track designation to small molecule for Fragile X

Rewiring the Brain… Dr. Peter Vanderklish, Chief Scientific Officer, Spinogenix

Companies To Watch: Spinogenix

Enhancing Neurodegenerative Care: Dialogue Exchange with Stella Sarraf of Spinogenix

To Reverse Aging’s Clock, Adjust the Cell’s Machinery

FDA Clears Phase 1/2 Clinical Trial for Spinogenix’s ALS Treatment SPG302

Spinogenix Announces FDA Clearance of IND Application Novel Therapy for the Treatment of ALS

First Synaptic Regenerative Therapy for Schizophrenia Under Investigation

Synapse-restoring pill set for human trials as novel schizophrenia treatment

Early Clinical Development of Synapse-Focused Agent SPG302 for Alzheimer Disease

World-first MND drug trial offers hope to those living with the disorder

Sydney Alzheimer’s Patients Will Be The First to Trial a New Drug

Hope Pill Will Turn Tables on Dementia

Addressing Root Causes of Brain Disorders with Innovative Therapeutics

Synapse-regenerating drug could reverse decline in Alzheimer’s

FDA OKs Phase 1/2 clinical trial of small molecule SPG302 in ALS

FDA clears investigational new drug application for clinical trial of ALS pill

Synapse-Generating Small Molecule for ALS Receives Nod from FDA for Clinical Trial

FDA grants IND clearance for Spinogenix’s ALS treatment trial

Breakthrough synapse-regenerating ALS pill moves to phase 2 human trials

Spinogenix’s Daily Pill SPG302 Receives FDA IND Nod for ALS Treatment

FDA grants orphan designation to Fragile X syndrome therapeutic

Spinogenix’s SPG601 Earns Orphan Drug Designation for Fragile X Syndrome

FDA clears Phase 2 trial of oral SPG601 in men with fragile X

FDA clears investigational new drug application for Fragile X treatment

Two major breakthroughs in Fragile X Syndrome treatments

Spinogenix’s Investigational New Drug Application for Novel Treatment for Fragile X Syndrome Cleared to Begin Phase II Trial

A Promising Treatment for MND

A new drug that could reverse the worst symptoms of MND is about to be trialled in Australia.

Novel motor neurone disease, MND, drug SPG302 to be trialled in Australia

ALS ONE Research Symposium – Presentation by Peter Vanderklish, PhD of Spinogenix

Spinogenix Lands $4M in New Federal Grants

Spinogenix awarded $1M to advance clinical testing of SPG302

Spinogenix: World-first trial giving hope to those living with MND

Clinical trial of oral ALS therapy SPG302 is enrolling in Australia | ALS News Today

Human Trial Gives Hope to MND Patients

Australians with MND will be the first in the world to trial a new drug

World first drug trial for MND treatment | Sky News Australia

A world-first trial for a new drug that may slow the progression of motor neurone disease is set to begin in Melbourne.

World first drug trial for MND treatment | The Australian

World first drug trial for MND treatment