Praxis Precision Gets FDA's Breakthrough Designation for Seizure Treatment

Dow Jones

Jul 17, 2025

By Dean Seal

Praxis Precision Medicines said federal regulators have granted their breakthrough therapy designation, or BTD, to its seizure treatment, relutrigine.

The clinical-stage biopharmaceutical company said Thursday that the Food and Drug Administration's designation was based on compelling results from a phase 2 trial and allows for speedier development and regulatory review.

"This BTD represents a significant milestone for our relutrigine program and further validates its potential," Chief Executive Marcio Souza said.

Shares rose 5.4% to $56.40 in premarket trading.

Write to Dean at dean.seal@wsj.com

(END) Dow Jones Newswires

July 17, 2025 08:24 ET (12:24 GMT)

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