林业发展局给予Praxis药物在基本震颤方面的突破性地位,在试验中显示出强有力的结果。 FDA grants breakthrough status to Praxis' drug for essential tremor, showing strong results in trials.

Praxis 精准医疗公司已获得FDA突破性治疗资格，适用于治疗原发性震颤的药物候选药物，该病影响了数百万美国人。 Praxis Precision Medicines has received FDA Breakthrough Therapy Designation for ulixacaltamide, a drug candidate treating essential tremor, a condition affecting millions of Americans. 根据积极的第3阶段试验结果,该药名的指定突显了该药在显著改善震颤症状和日常功能方面的潜力,比安慰剂具有更好的持续影响。 The designation, based on positive Phase 3 trial results, highlights the drug’s potential to significantly improve tremor symptoms and daily functioning, with better sustained effects than placebo. 美国食品和药物管理局的认可强调了需要更有效的治疗方法, The FDA’s recognition underscores the need for more effective treatments, as current options often fall short. Praxis计划于2026年初提交监管批准申请,并期望继续取得进展。 Praxis plans to submit a regulatory approval application in early 2026 and expects continued development progress.