PRAXIS: Tinanggap ng FDA ang NDA para sa ulixacaltamide sa essential tremor; PDUFA 29 Enero 2027

Tinanggap ng FDA ang NDA para sa ulixacaltamide HCl para sa essential tremor at itinakda ang target na petsa ng aksyon ng PDUFA sa Enero 29, 2027. Walang planong advisory committee meeting.

Mahahalagang fact

Na-file: Abr 14, 2026, 09:11 PM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: PRAXPraxis
Asset: ulixacaltamide
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Ene 29, 2027 · Positibo

Sipi mula sa source

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