Spinogenix Announces Full Enrollment in its Phase 2 Trial Evaluating SPG302 as a First-in-Class Synaptic Regenerative Therapy for Alzheimer’s Disease

First Cohort Results to be Presented at AAIC in Toronto, July 2025  FDA Clears IND in Alzheimer’s Disease, Enabling Future Expansion to U.S. LOS ANGELES, June 24, 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 full enrollment of its Phase 2 clinical trial in Australia evaluating…

Spinogenix’s SPG302, the First Synaptic Regenerative Therapy to Treat ALS, Granted Orphan Drug Designation by the European Medicines Agency

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 European Medicines Agency (EMA) has granted orphan drug designation (ODD) to SPG302 for the treatment of people living with Amyotrophic Lateral Sclerosis (ALS). SPG302 is…

Spinogenix Announces FDA-Authorized Expanded Access Program for SPG302, the First Synaptic Regenerative Therapy to Treat ALS

FDA Authorizes Expanded Access Program (EAP) to Help Provide Access to SPG302 for 200 ALS Individuals Ineligible for Clinical Study EAP Supports Real-world Data Collection Concurrent to Ongoing Clinical Studies of SPG302 LOS ANGELES – May 5, 2025 – Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives…

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

LOS ANGELES, CA, March 31, 2025 – Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced open enrollment for its Phase 2 trial of SPG302 for the treatment of people with schizophrenia, following clearance of its Investigational New Drug (IND) application by the…

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

Topline Results Announced at NIH Fragile X Centers of Excellence Conference U.S. FDA Previously Granted Orphan Disease Designation and Fast Track Designation to SPG601 LOS ANGELES, Calif., February 11, 2025 — Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced topline results from a…

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

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 LOS ANGELES, Jan. 13, 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 Appoints American Football Hall of Famer and Health Advocate Steve Young to its Board of Directors

LOS ANGELES, Calif., November 25, 2024—Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of people worldwide, today announced the appointment of Steve Young, hall of fame former quarterback of the San Francisco 49’ers and prominent health advocate, to its board of directors. Mr. Young brings his background…

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

LOS ANGELES, Calif., October 16, 2024 — 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 Dr. Robert N. Weinreb, MD, has joined its science advisory board (SAB). The addition of Dr. Weinreb, Chair and Distinguished Professor of Ophthalmology at University of…

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

Phase 2 trial is designed to evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia LOS ANGELES, Calif., September 25, 2024 — 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 with the approval…

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

SPG302 is a once-a-day pill with the potential to regenerate synapses to reverse declines in cognitive function in people with Alzheimer’s disease LOS ANGELES, Calif., August 1, 2024 — 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 enrollment is now open…