Record mula sa primary source

Decision-gradeTopline na resulta

Praxis: Ipinakita ng topline ng EMBRAVE Part A ang 77% na pagbawas sa seizure gamit ang elsunersen

The 8-K discloses positive Phase 1/2 EMBRAVE Part A topline results for elsunersen in SCN2A DEE, including 77% placebo-adjusted seizure reduction and 100% functional improvement. The same filing also notes FDA priority-review acceptance of relutrigine NDA with a September 27, 2026 PDUFA date.

Mahahalagang fact

Na-file
Abr 6, 2026, 08:23 PM
Kaganapan
Topline na resulta
Direksyon
Positibo
Kumpanya
PRAXPraxis
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Desisyon ng FDA (PDUFA) · Dis 27, 2026 · Positibo
kaligtasan
walang gamot-nauugnay na SAEs, walang pagtigil, walang neuroinflammation hanggang 8 mg
Napanatili sa OLE
hanggang isang taon
kalayaan sa seizure
57% ng mga pasyente ang nagkaroon ng ≥28-araw na panahon
functional pagpapabuti
100% ng elsunersen pasyente vs 0% placebo
placebo adjusted seizure pagbabawas
77% (p=0.015, 95% CI [33,92])

Sipi mula sa source

prax-20260406 FALSE 0001689548 0001689548 2026-04-06 2026-04-06 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 6, 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

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