PRAXIS: FDA aceita NDA para ulixacaltamida no tremor essencial; PDUFA 29 Jan 2027

A FDA aceitou a NDA para cloridrato de ulixacaltamida para tremor essencial e definiu a data-alvo de ação PDUFA para 29 de janeiro de 2027. Nenhuma reunião do comitê consultivo está planejada.

Fatos principais

Arquivado: 14 de abr. de 2026, 21:11
Evento: Pedido aceito
Direção: Positivo
Empresa: PRAXPraxis
Ativo: ulixacaltamide
Fonte: SEC 8-K
Confiança: Com fonte
Calendário: Decisão da FDA (PDUFA) · 29 de jan. de 2027 · Positivo

Trecho da fonte

prax-20260414 FALSE 0001689548 0001689548 2026-04-14 2026-04-14 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 14, 2026 PRAXIS PRECISION MEDICINES, INC. (Exact name of registrant as specified in its charter) Delaware 001-39620 47-5195942 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) Praxis Precision Medicines, Inc. 99 High Street , 30th Floor Boston , Massachusetts 02110 (Address of principal executive offices, including zip code) ( 617 ) 300-8460 (Registrant’s telephone number, including area code) Not Applicable (Former Name or Former Address, if

SEC 8-K