Spinogenix announces that the WHO has approved 'codabakalner' as the nonproprietary name for SPG601, a therapy for Fragile X syndrome.

Codabakalner is a First-in-Class Investigational Therapy Entering Phase 2b/3 Development for Fragile X Syndrome LOS ANGELES, July 16, 2026 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering novel therapeutics that have the potential to restore synapses...

Spinogenix, Inc. has launched the CLARITY trial for SPG601, an oral treatment for Fragile X Syndrome, aiming to restore synaptic function.

A recent peer-reviewed study shows that Spinogenix's SPG601 could effectively improve cognitive functions in patients with Fragile X Syndrome, marking a significant breakthrough in treatment.

Spinogenix announces collaboration with FRAXA Research Foundation to advance Phase 2b trial of SPG601, aimed at treating Fragile X Syndrome.

Spinogenix reveals full Phase 2a trial results for SPG601, a pioneering treatment for Fragile X Syndrome, showcasing promising cognitive improvements.

Spinogenix has achieved a significant milestone with the FDA's support for SPG601, a pioneering treatment for Fragile X syndrome, addressing crucial needs in patient care.

Spinogenix's SPG601 has been granted orphan drug designation by the EMA for treating Fragile X Syndrome, marking a significant step in therapies for this condition.

Spinogenix announces promising results from its Phase 2 study of SPG601 for treating Fragile X syndrome, showing potential to improve quality of life.

The FDA's Fast Track designation for Spinogenix's SPG601 marks significant progress in developing a treatment for Fragile X syndrome, a key cause of autism.

LOS ANGELES, April 23, 2026 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics designed to restore synapses to improve the lives of patients, is initiating CLARITY, a Phase 2b/3 adaptive trial evaluating SPG601 in male...

SPG601 is a first-in-class, BK-modulator with the potential to improve cognitive, emotional and sensory symptoms in FXS patients LOS ANGELES, March 2, 2026 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics with the...

SPG601, Granted Fast Track Designation by the FDA, Reduced Signature Changes in High-Frequency Gamma Band Activity in Fragile X Syndrome Patients, a Common Inherited Form of Intellectual Disability and Autism, and Improved Measures of Cognitive Impairment Dr. Craig Erickson, Spinogenix...

Spinogenix has reached agreement with the FDA on important design elements for a Phase 2B/3 clinical trial of SPG601 for the treatment of FXS There Are No FDA-Approved Treatments for FXS, a Leading Inherited Form of Intellectual Disability and Known Cause of Autism LOS ANGELES, Sept. 2,...

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, Feb. 11, 2025 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage…