Praxis Precision Medicines Inc. filed SEC Form 8-K: Other Events
$PRAX
Biotechnology: Pharmaceutical Preparations
Health Care
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
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
Praxis Precision Medicines, Inc.
(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 Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
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Item 8.01. Other Events.
Praxis Precision Medicines, Inc. (the “Company”) is providing the following business updates:
Elsunersen
The Company announced positive topline results from the EMBRAVE Part A trial of elsunersen in pediatric patients with early-seizure onset SCN2A development and epileptic encephalopathy (“DEE”). EMBRAVE Part A is a randomized, placebo-controlled Phase 1/2 trial evaluating the safety and efficacy of ascending doses of elsunersen in patients with SCN2A DEE. Nine patients, aged 2-12 years old, were randomized 3:1 to receive either elsunersen or sham procedure every 4 weeks for 24 weeks, followed by an open-label extension (“OLE”); all 9 patients continued to the OLE. Patients received a starting dose of 1 mg with optional dose escalation based on observed seizure reduction and individual tolerability.
Key results from EMBRAVE Part A
Efficacy
•Elsunersen treatment led to a 77% placebo-adjusted seizure reduction from baseline (p=0.015, 95 CI [33,92]).
•57% of patients had at least a 28-day period of seizure freedom.
•Efficacy was sustained in the OLE for up to one year.
•100% of elsunersen patients improved across sleep, motor function, muscle tone, attention or neuropsychomotor development compared to no improvements in placebo group.
Safety
•Elsunersen was well-tolerated, with no drug-related serious adverse events, no discontinuations and no neuroinflammation signals at doses up to 8 mg.
•Most treatment-emergent adverse events (“TEAEs”) were mild to moderate. TEAEs were consistent with the EMBRAVE Part 1 study.
Relutrigine
The U.S. Food and Drug Administration (the “FDA”) has accepted for priority review the Company’s New Drug Application for relutrigine for the treatment of SCN2A and SCN8A DEEs. The FDA has set a target action date under the Prescription Drug User Fee Act of September 27, 2026.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PRAXIS PRECISION MEDICINES, INC. | |||||||||||
| Date: April 6, 2026 | By: | /s/ Marcio Souza | |||||||||
| Marcio Souza | |||||||||||
| Chief Executive Officer | |||||||||||