Praxis Precision Medicines Gets FDA Priority Review for Relutrigine

By Elias Schisgall

Praxis Precision Medicines' New Drug Application for relutrigine will receive priority review by the Food and Drug Administration.

The clinical-stage biopharmaceutical company said Monday that the FDA has set a target action date for the application of Sept. 27.

"Our first FDA acceptance of an NDA submission marks a significant milestone in our evolution to a commercial-stage company and an important step toward delivering innovative, precision neuroscience therapies to patients in need," Chief Executive Marcio Souza said.

The application seeks approval for relutrigine to treat certain types of developmental and epileptic encephalopathies, which Souza said have no currently approved targeted therapies.

Shares of Praxis rose 0.9% to $279.00 in after-hours trading Monday.

Write to Elias Schisgall at [e-mail]

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03-30-26 1648ET