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): ~~February~~April 196, 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 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:


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trade

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share

PRAX

The Nasdaq Global Select Market

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 ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 28.0201. Other ~~Results of Operations and Financial Condition~~Events.

~~On February 19, 2026,~~ Praxis Precision Medicines, Inc. (the “Company”) ~~announced its financial results for the quarter and full year ended December 31, 2025. A copy of the press release containing these announcements~~ is ~~furnished~~providing ~~as Exhibit 99.1 to this Current Report on Form 8-K (~~the ~~“Current~~following ~~Report”).~~business updates:

The information in this Current Report under Item 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.Elsunersen

~~Item 9~~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”).01 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. ~~Financial~~Nine ~~Statements~~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 ~~Exhibits~~individual tolerability.

~~(d)~~Key ~~Exhibits~~results from EMBRAVE Part A

ExhibitNo.						Description
99.1						Press Release, dated February 19, 2026
104						Cover Page Interactive Data File (embedded within the inline XBRL document)

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: February 19, 2026	By:	/s/ Marcio Souza
Date: April 6, 2026	By:	/s/ Marcio Souza
		Marcio Souza
		Chief Executive Officer

Filing Compare · Praxis Precision Medicines, Inc.