PRAXIS: FDA menerima NDA untuk ulixacaltamide pada essential tremor; PDUFA 29 Jan 2027

FDA telah menerima NDA untuk ulixacaltamide HCl untuk essential tremor dan menetapkan tanggal target aksi PDUFA pada 29 Januari 2027. Tidak ada pertemuan komite penasihat yang direncanakan.

Fakta utama

Diajukan: 14 Apr 2026, 21.11
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: PRAXPraxis
Aset: ulixacaltamide
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 29 Jan 2027 · Positif

Kutipan sumber

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