Pasithea Therapeutics Announces Orphan Drug Designation by FDA of PAS-004 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

▤ Summary

Pasithea Therapeutics says the FDA granted Orphan Drug Designation to PAS-004 for ALS. The designation can provide tax credits, fee exemptions, and potential market exclusivity if the therapy is approved. Pasithea is using the designation to support ongoing development of PAS-004 in ALS and other diseases tied to the MAPK pathway. The company also notes prior ALS Association grant support for studying the drug in ALS.

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