Pasithea Therapeutics Corp. (KTTA) on Tuesday said the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead candidate, PAS-004, for the treatment of Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease that affects motor neurons.
The company said the designation is intended to support the development of therapies for rare diseases and may provide several incentives, including tax credits for qualified clinical trials, exemption from certain FDA fees, and the potential for seven years of market exclusivity following regulatory approval.
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