Spinogenix Receives U.S. FDA Fast Track Designation for Tazbentetol for the Treatment of ALS

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LOS ANGELES, May 5, 2026 – Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering novel therapeutics that have the potential to restore synapses to improve the lives of patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to tazbentetol for the treatment of people with amyotrophic lateral sclerosis (ALS). Tazbentetol is a once-a-day pill being developed as a first-in-class, regenerative treatment with the potential to restore synapses, the key connections between neurons that allow people to think, plan, remember and control movement.

  • Designation Enables an Enhanced Development Path for Tazbentetol and Underscores the Unmet Need for New Treatments In ALS
  • Milestone Follows Recent Announcement of Phase 2a Results Showing Preliminary Evidence that Tazbentetol’s First in Class Synaptic Regenerative Mechanism Slowed Rate of Decline in ALS Patients
  • In 2021, the FDA granted Orphan Drug designation to tazbentetol for the treatment of ALS. With this Fast Track designation, Spinogenix can expedite the development and review of tazbentetol in ALS.

    • “Receiving Fast Track Designation is another significant milestone in our journey to develop a new therapeutic to combat ALS,” said Dr. Stella Sarraf, CEO and Founder at Spinogenix. “We remain focused on developing tazbentetol as the first investigational therapy designed to restore synapse function. This designation will allow us to work more closely with the FDA in planning our next trial to help accelerate its development to address this critical unmet need.”

    At the International Symposium on ALS/MND conference in December 2025, Spinogenix announced the Phase 2a study of tazbentetol in ALS (NCT05882695), demonstrating a favorable safety and tolerability profile with 82% of patients exhibiting a stable or improved rate of decline at the end of treatment, as assessed with ALSFRS-R. On average, these patients also exhibited a 76% slower rate of decline through six months compared to historical controls matched from the PRO-ACT database. The findings were supported by quantitative and objective biomarker electroencephalogram (EEG) findings, revealing improvements in ALS-associated patterns and supporting the apparent benefits observed in the rate of functional decline.

    Spinogenix continues to support patients through its Expanded Access Program (EAP), which provides individuals with ALS the opportunity to receive tazbentetol who are ineligible for clinical trials.

    “I do not see ALS as a disease without hope, but rather one where everyone lives” said Dan Doctoroff, founder and chairman of Target ALS, and the first individual to receive tazbentetol in the U.S. under a FDA-authorized EAP. “I am thrilled that the FDA has recognized Spinogenix’s efforts to help meet my vision, and I could not be more encouraged by what the Company has achieved.”

    About Tazbentetol

    Tazbentetol (formerly SPG302) is a once-a-day pill being developed as a regenerative treatment for neurodegenerative and neuropsychiatric diseases with the unique ability to restore synapses, the key connections between neurons that allow people to think, plan, remember, and control movement. The preliminary evidence of the synaptic regenerative activity of tazbentetol represents a first-in-class approach to treating these diseases and has the potential to reverse declines in cognitive, respiratory, and motor function. Tazbentetol is being evaluated as an investigational therapeutic in Alzheimer’s disease (NCT06427668), ALS (NCT05882695) and Schizophrenia (NCT06442462).

    About Spinogenix

    Current treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction.

    Spinogenix is developing two novel therapeutics: Tazbentetol (SPG302), which is designed to trigger neurons to produce new glutamatergic synapses and restore cognitive, motor, and other functions in ALS, Alzheimer’s disease, schizophrenia and other diseases; and SPG601, which is designed to work at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS) that underlie many core symptoms. The company has received Orphan Drug designations from FDA and EMA for tazbentetol in ALS as well as FDA Orphan Drug and Fast Track designations for SPG601 in FXS. More information on Spinogenix can be found at www.spinogenix.com or follow us on LinkedIn.

    About Expanded Access to Tazbentetol

    Access to tazbentetol is available in the U.S. for certain adults with ALS who meet eligibility criteria for participation in the FDA-authorized Expanded Access Program. More information about the U.S. EAP can be requested through [email protected]

    Source: Spinogenix, Inc.

    Source: HealthDay

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    Posted : 2026-05-06 09:30

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