PRAX: topline studi EMBOLD menunjukkan penurunan kejang 53% dengan relutrigine

The registrational EMBOLD cohort for relutrigine in SCN2A/SCN8A DEEs met its primary endpoint and was stopped early for efficacy. The company will meet the FDA in the coming weeks to discuss next steps and NDA timing.

Fakta utama

Diajukan: 8 Des 2025, 21.18
Peristiwa: Hasil topline
Arah: Positif
Perusahaan: PRAXPraxis
Aset: ulixacaltamide
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 29 Jan 2027 · Positif
N: 51
peningkatan hari bebas kejang motorik: 66% (p=0.034)
pengurangan kejang yang disesuaikan plasebo: 53% (p<0.0002)

Kutipan sumber

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