PRAX: EMBOLD na pag-aaral na topline ay nagpapakita ng 53% pagbawas sa seizure para sa relutrigine

Ang registrational na EMBOLD cohort para sa relutrigine sa SCN2A/SCN8A DEEs ay nakamit ang pangunahing endpoint at maagang itinigil dahil sa efficacy. Ang kumpanya ay makikipagkita sa FDA sa mga susunod na linggo upang talakayin ang mga susunod na hakbang at timing ng NDA.

Mahahalagang fact

Na-file: Dis 8, 2025, 09:18 PM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: PRAXPraxis
Asset: ulixacaltamide
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Ene 29, 2027 · Positibo
N: 51
pagtaas ng araw na walang motor seizure: 66% (p=0.034)
Pagbawas ng atake na naayos batay sa placebo: 53% (p<0.0002)

Sipi mula sa source

prax-20251204 FALSE 0001689548 0001689548 2025-12-04 2025-12-04 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): December 4, 2025 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,

SEC 8-K