BUZZ-Praxis jumps on positive meeting with FDA for tremor drug, epilepsy trial success

Reuters
2025.12.05 14:48
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Praxis Precision Medicines shares surged 36% after the FDA agreed on a New Drug Application for its tremor drug, ulixacaltamide. The company also reported positive interim results for its epilepsy treatment, relutrigine. Jefferies estimates peak sales could exceed $2.5 billion, with potential NDA acceptance and approval in 2026. The stock is up ~235% YTD.

(Updates)

Shares of drug developer Praxis Precision Medicines (PRAX.O) rise 36% to $257.89, the highest in nearly four years

Co late on Thursday said U.S. FDA has agreed on NDA for its tremor drug, ulixacaltamide

NDA stands for “New Drug Application”

Co also reported positive interim results for its rare epilepsy treatment, relutrigine

“Preliminary checks suggest peak sales could exceed $2.5 billion and sees meaningful catalysts ahead, including NDA acceptance and potential approval in 2026” - Jefferies

Co’s ulixacaltamide showed meaningful benefit for essential tremor, a condition causing involuntary shaking

Including session’s move, stock up ~235% YTD