Stay current with Spinogenix in the media, view our latest expert interviews, featured articles, and industry insights regarding the future of neuroscience.
The Synapse Secret: How One Molecule Normalized Brain Activity in Fragile X Patients
February 11, 2026
What if the most effective way to treat some of the most devastating brain disorders isn’t by targeting symptoms in isolation, but by repairing the brain’s most fundamental unit of...
Spinogenix’s Alzheimer’s drug touts disease-modifying potential in Phase IIa study
December 9, 2025
Topline data from a completed phase 2a trial (NCT05882695) highlighted the therapeutic benefits of SPG302, a synaptic regenerative drug, to treat patients with amyotrophic lateral sclerosis (ALS). All told, treatment...
Restoring Lost Synapses in ALS, Fragile X and More with Spinogenix’s Dr. Peter Vanderklish — Episode 233
November 19, 2025
In this week’s episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Peter Vanderklish, PhD, chief scientific officer at Spinogenix, a...
Experimental oral therapy SPG302 may slow ALS progression
November 7, 2025
SPG302, an experimental oral therapy for amyotrophic lateral sclerosis (ALS), was well tolerated in an early clinical trial, and initial findings suggest it may help slow disease progression. The new...
Preliminary Phase 2 Data Support Therapeutic Development of Synaptic Regenerative Drug SPG302 in ALS
November 6, 2025
Topline data from a completed phase 2a trial (NCT05882695) highlighted the therapeutic benefits of SPG302, a synaptic regenerative drug, to treat patients with amyotrophic lateral sclerosis (ALS). All told, treatment...
Spinogenix’s ALS hopeful to advance to registrational trial
November 5, 2025
During the Phase IIa study (NCT05882695), SPG302 met its primary endpoint of safety and tolerability in the ALS population, with no treatment-emergent serious adverse events (SAEs) reported over a six-month...
SPG601 calms brain activity in men with fragile X, helping them to focus
October 28, 2025
Spinogenix’s experimental oral therapy SPG601 reduced abnormal high-frequency brain activity in men with fragile X syndrome and increased their selective attention, allowing them to better focus on one type of...
Synaptic Regeneration: A New Frontier in Schizophrenia Treatment
September 25, 2025
Our approach to treating schizophrenia has changed little for more than half a century. But a shift may be underway, emphasizing novel approaches to the disease and its underlying pathology....
Spinogenix Receives Positive FDA Feedback for SPG601 in Fragile X Syndrome
September 12, 2025
Spinogenix announced positive feedback from a Type C meeting with the FDA on SPG601, its first-in-class oral therapy for Fragile X syndrome (FXS), following Phase IIa trial (NCT06413537) results showing...
What Inspired You to Pursue a Career in Life Sciences? — Xtalks Open Mic
August 11, 2025
Every journey into life sciences starts somewhere. For some, it was a fascination with biology in high school. For others, it was watching a loved one battle illness or witnessing...
Restoring Synapses to Fight Neurodegeneration with Spinogenix CEO Dr. Stella Sarraf
August 1, 2025
In this episode of the Xtalks Life Science Podcast, Ayesha speaks with Stella Sarraf, PhD, founder, CEO and director of Spinogenix, a company pioneering neurodegenerative therapeutics designed to restore synapses...
SPG601 granted orphan drug status in EU for treating fragile X
July 29, 2025
SPG601, an oral treatment candidate now in clinical testing, has been granted orphan drug status for fragile X syndrome in the European Union. This designation, awarded by the European Medicines...
Early positive signals of cognitive outcomes in mild to moderate Alzheimer patients treated with the synaptic regenerative small molecule, SPG302 – AAIC 2025 Poster
July 28, 2025
Spinogenix has developed a novel small molecule synaptic regenerative therapy, SPG302, to restore synapses in AD (and other synaptopathies), with the goal of helping patients recover lost function. This poster...
First synaptic regenerative therapy for ALS gets orphan status
June 6, 2025
The European Medicines Agency (EMA) has granted orphan drug designation (ODD) to Spinogenix’s SPG302 for the treatment of people living with amyotrophic lateral sclerosis (ALS). SPG302 is being developed as...
Regulatory actions for June 4, 2025
June 4, 2025
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Beam, Maat, Pheast, Sanofi, Spinogenix, Teijin, Tenpoint.
Spinogenix’s SPG302, the First Synaptic Regenerative Therapy to Treat ALS, Granted Orphan Drug Designation by the European Medicines Agency
June 3, 2025
LOS ANGELES, June 3, 2025 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced that the...
Spinogenix Launches Phase II Trial for Synaptic Regenerative Therapy in Schizophrenia
May 8, 2025
Spinogenix announced open enrollment for its Phase II trial of SPG302, the first synaptic regenerative therapy for schizophrenia. According to the company, the launch of the Phase II trial comes...
Novel Schizophrenia Drug Explored; Daridorexant Treats Insomnia + Nocturia; ADHD Drug Trialed
May 8, 2025
Spinogenix Inc. opened its enrollment in March for a Phase 2 trial of SPG302, the first potential regenerative treatment for individuals with schizophrenia, after it received clearance of an Investigational...
Spinogenix’s ALS Breakthrough: A Los Angeles-Based Biotech’s Bold Leap Forward
May 8, 2025
Lead: On May 5, 2025, Los Angeles-based Spinogenix, Inc., a clinical-stage biopharmaceutical company, announced a landmark achievement: the FDA’s authorization of an Expanded Access Program (EAP) for its investigational drug...
FDA Authorizes Expanded Access Program for ALS Treatment SPG302
May 8, 2025
According to a new announcement, the FDA has authorized Spinogenix’s expanded access program (EAP) for its investigational amyotrophic lateral sclerosis (ALS) agent SPG302 in the United States for patients living...
Inside A Bold New Approach To Alzheimer’s
May 2, 2025
Spinogenix Founder and CEO Stella Sarraf, PhD. sits with ForbesWomen Editor Maggie McGrath at the Nasdaq MarketSite to discuss her company's novel approach to treating neurodegenerative disease at the synaptic...
Reset the Clock on Schizophrenia: SPG302, A Regenerative Treatment
April 2, 2025
SPG302, a regenerative treatment for schizophrenia, could reset the clock on the brain.
Behind the Steering Wheel of Your Brain: Residual Negative and Cognitive Symptoms in Schizophrenia
April 1, 2025
Treatments that target negative and cognitive symptoms of schizophrenia could put patients in better control of their life.
Phase 2 Trial Open Enrollment for SPG302, First Synaptic Regenerative Approach to Treat Schizophrenia
March 31, 2025
Spinogenix announced open enrollment for the phase 2 trial of SPG302, the first synaptic regenerative approach to treat schizophrenia with the potential to improve outcomes across all symptom domains.
SPG302: A Synaptic Regenerative Treatment Option for Schizophrenia
March 31, 2025
A schizophrenia research expert weighs in on the recent announcement concerning SPG302 for the treatment of individuals with schizophrenia.
SPG601 found to reduce measure of abnormal brain activity in fragile X
March 10, 2025
Therapy helps normalize brain activity associated with learning, memory: Trial
FDA Grants Fast Track Designation to Spinogenix’s SPG601 for Treatment of FXS
February 10, 2025
Milestone Highlights Urgent Need for a Novel Therapeutic to Treat People with FXS. FDA Designation Enables Expedited Clinical Development and Regulatory Review Timelines for SPG601
FDA Designation for SPG601 Highlights New Hope for FXS Treatment
February 10, 2025
Spinogenix, Inc., a clinical-stage biopharmaceutical company dedicated to developing innovative therapies, has received a significant boost from the FDA with the Fast Track designation for its promising drug SPG601. This...
Novel BK Channel Activator Fast Tracked for Fragile X Syndrome
February 10, 2025
The Food and Drug Administration (FDA) has granted Fast Track designation to SPG601 for the treatment of people with Fragile X syndrome (FXS), a rare inherited cause of intellectual disability...
Personalized medicine; astroglia organoids; fast track for fragile X drug
February 10, 2025
Here is a roundup of autism-related news and research spotted around the web for the week of 20 January.
Spinogenix’s SPG601 Receives FDA Fast Track Designation for Fragile X Syndrome
February 10, 2025
The company announced the completion of its phase 2 study assessing SPG601 in adult men with FXS, with topline findings expected to be reported by end of the first quarter...
FDA grants fast-track designation to small molecule for Fragile X
January 14, 2025
The FDA granted fast track designation to a novel small molecule therapeutic to address Fragile X syndrome
Rewiring the Brain… Dr. Peter Vanderklish, Chief Scientific Officer, Spinogenix
November 21, 2024
This week on BioTech Nation, Dr. Peter Vanderklish, Chief Scientific Officer at Spinogenix discusses their clinical trials focused on regenerating synapses to repair brain connections and offer hope for conditions...
Enhancing Neurodegenerative Care: Dialogue Exchange with Stella Sarraf of Spinogenix
October 17, 2024
To Reverse Aging’s Clock, Adjust the Cell’s Machinery
October 11, 2024
If we want to increase longevity and reverse aging, we need to get serious. Forget myth. There is no fountain of youth. And we need to move beyond practical advice....
FDA Clears Phase 1/2 Clinical Trial for Spinogenix’s ALS Treatment SPG302
October 1, 2024
The cleared phase 1/2 clinical trial will assess SPG302 as a once-a-day pill among patients with amyotrophic lateral sclerosis.
Spinogenix Announces FDA Clearance of IND Application Novel Therapy for the Treatment of ALS
October 1, 2024
Spinogenix, Inc. recently announced the US FDA has cleared the Investigational New Drug (IND) application for its Phase 1/2 clinical trial of SPG302 for the treatment of people with Amyotrophic...
First Synaptic Regenerative Therapy for Schizophrenia Under Investigation
September 30, 2024
Multiple sites are now enrolling participants in a phase 2 clinical trial to evaluate SPG302, the first synaptic regenerative therapy for schizophrenia.
Synapse-restoring pill set for human trials as novel schizophrenia treatment
September 30, 2024
A once-a-day pill that regenerates lost nerve cell connections is being trialed as a schizophrenia treatment
Early Clinical Development of Synapse-Focused Agent SPG302 for Alzheimer Disease
August 15, 2024
Peter Vanderklish, PhD, chief science officer at Spingogenix, commented on a recently initiated phase 2 trial assessing investigational SPG302, a synaptic-regenerative agent in development for Alzheimer disease
World-first MND drug trial offers hope to those living with the disorder
August 12, 2024
A world-first trial for a drug that researchers hope could not only slow down the progression but actually reverse the condition of motor neurone disease is currently in phase two...
Sydney Alzheimer’s Patients Will Be The First to Trial a New Drug
August 8, 2024
Sydney Alzheimer's patients will be the first to trial a new drug which neurologists claim could be a game changer. Instead of just slowing the progression of the disease, the...
Hope Pill Will Turn Tables on Dementia
August 8, 2024
By Lisa Wachsmuth If there was a magic pill to slow the progression of Phil Hazel’s Alzheimer’s disease and allow him to forever retain the happy memories he’s made with...
Addressing Root Causes of Brain Disorders with Innovative Therapeutics
August 1, 2024
Neuroscience is a complex market encompassing a range of neurological conditions. Drug research and development for diseases related to the nervous system has always been challenging. While the oncology sector...
Synapse-regenerating drug could reverse decline in Alzheimer’s
June 26, 2024
Spinogenix has initiated a Phase II trial to evaluate SPG302 for the treatment of adult participants with mild-to-moderate Alzheimer’s disease (AD), following approval for the trail in Australia. The study...
FDA OKs Phase 1/2 clinical trial of small molecule SPG302 in ALS
June 7, 2024
Spinogenix will soon launch a Phase 1/2 clinical trial in the U.S. to test its investigational small molecule SPG302 in people with amyotrophic lateral sclerosis (ALS).
FDA clears investigational new drug application for clinical trial of ALS pill
June 5, 2024
The FDA has cleared an investigational new drug application for a phase 1/2 clinical trial to examine a novel, once-daily pill for the treatment of individuals with amyotrophic lateral sclerosis,...
Synapse-Generating Small Molecule for ALS Receives Nod from FDA for Clinical Trial
May 31, 2024
The Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SPG302 (Spinogenix, San Diego, CA) for evaluation as a potential treatment for people with amyotrophic...
FDA grants IND clearance for Spinogenix’s ALS treatment trial
May 31, 2024
A Phase I/II study of SPG302 is underway in Australia with the dosing of healthy volunteer cohorts completed.
Breakthrough synapse-regenerating ALS pill moves to phase 2 human trials
May 31, 2024
A unique once-a-day pill to treat ALS has been approved for ongoing clinical trials
Spinogenix’s Daily Pill SPG302 Receives FDA IND Nod for ALS Treatment
May 31, 2024
The FDA has cleared the IND application for SPG302, a novel ALS treatment focusing on synapse regeneration. This once-daily pill aims to improve cognitive and motor functions by restoring neuron...
FDA grants orphan designation to Fragile X syndrome therapeutic
May 22, 2024
The FDA has granted orphan drug designation to a small molecule therapeutic for individuals with Fragile X syndrome. SPG601 is a novel calcium-activated potassium (BK) channel activator that works by...
Spinogenix’s SPG601 Earns Orphan Drug Designation for Fragile X Syndrome
May 21, 2024
In the United States, Orphan Drug designation is granted by the FDA to drugs or biologics designed to treat, diagnose, or prevent a rare condition affecting fewer than 200,000 people...
FDA clears Phase 2 trial of oral SPG601 in men with fragile X
May 3, 2024
The U.S. Food and Drug Administration (FDA) has given Spinogenix the green light for a Phase 2 clinical trial that will test its investigational oral therapy SPG601 in adult men...
FDA clears investigational new drug application for Fragile X treatment
April 19, 2024
The FDA has cleared an investigational new drug application for a small molecule therapeutic to treat those with Fragile X syndrome, according to the manufacturer. In a press release, San...
Two major breakthroughs in Fragile X Syndrome treatments
April 16, 2024
Spinogenix has received approval from the US Food and Drug Administration (FDA) for a Phase II clinical trial of SPG601 for Fragile X Syndrome (FXS), the same week that the...
Spinogenix’s Investigational New Drug Application for Novel Treatment for Fragile X Syndrome Cleared to Begin Phase II Trial
April 15, 2024
Phase IIa clinical trial of SPG60 for Fragile X syndrome offers hope for disease with no current FDA-approved treatment options.
A Promising Treatment for MND
February 26, 2024
A new drug that could reverse the worst symptoms of M&D is about to be trial here in Australia. Researchers have told Reed Butler the once a day pill is...
A new drug that could reverse the worst symptoms of MND is about to be trialled in Australia.
February 21, 2024
Australian motor neuron disease patients will be the first in the world to trial a new drug which could reverse the effects of the terminal illness scientists hope the daily...
Novel motor neurone disease, MND, drug SPG302 to be trialled in Australia
February 18, 2024
Australian motor neurone disease patients will be the first in the world to trial a “novel” treatment that scientists hope could not only slow — but actually reverse — the...
ALS ONE Research Symposium – Presentation by Peter Vanderklish, PhD of Spinogenix
November 15, 2023
Our 4th Annual ALS ONE Research Symposium was held on November 29th & 30th 2021, hosted by our research team: Dr’s Merit Cudkowicz, MD, MSc of MGH, Robert Brown, MD,...
Spinogenix Lands $4M in New Federal Grants
November 1, 2023
Oinical-stage biophanna finn Spinogenix has been awarded an additional $4 million in various federal funds to continue its development of drugs aimed at targeting s
Spinogenix: World-first trial giving hope to those living with MND
September 15, 2023
A world-first trial for a drug that researchers hope could slow the progression of motor neurone disease is being run in Melbourne. For patients living with MND such as Greg...
Clinical trial of oral ALS therapy SPG302 is enrolling in Australia | ALS News Today
August 16, 2023
First in-human study is recruiting up to 112 patients, healthy volunteers.
Human Trial Gives Hope to MND Patients
July 16, 2023
Australians with MND will be the first in the world to trial a new drug
June 16, 2023
Australians living with motor neurone disease will be the first in the world to try a groundbreaking new treatment. Clinical trials will take place in Melbourne - chosen for its...
World first drug trial for MND treatment | Sky News Australia
April 16, 2023
Researchers believe they can slow the progression of Motor Neuron Disease with a drug called SPG302 and it’s being trialled for the first time on humans. The drug is a...
A world-first trial for a new drug that may slow the progression of motor neurone disease is set to begin in Melbourne.
March 16, 2023
World first drug trial for MND treatment | The Australian
February 16, 2023
Researchers believe they can slow the progression of Motor Neuron Disease with a drug called SPG302 and it’s being trialled for the first time on humans. The drug is a...
World first drug trial for MND treatment
January 16, 2023
Researchers believe they can slow the progression of Motor Neuron Disease with a drug called SPG302 and it’s being trialled for the first time on humans. The drug is a...