Praxis Precision Gets FDA's Breakthrough Designation for Seizure Treatment

Dow Jones

2025/07/17

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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