-Following positive pre-submission meetings with regulators, Prilenia Therapies plans to submit its MAA (Marketing Authorization Application) for pridopidine, in Huntington’s disease (HD) in mid-2024.

-If approved, pridopidine could be commercially available to patients in Europe as early as 2025.

Activation of the S1R by pridopidine enhances the clearance of toxic proteins, increases energy production, and reduces cellular stress and inflammation.  These mechanisms are crucial for a neuron’s function and survival.

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“Prilenia holds orphan drug designation for pridopidine in both HD and ALS in the United States and EU. In addition, pridopidine has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of HD. Drugs that receive Fast Track designation may be eligible for more frequent communications with the FDA and may also qualify for accelerated approval and priority review of new drug applications.”