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Form 8-K

sec.gov

8-K — Praxis Precision Medicines, Inc.

Accession: 0001104659-26-080356

Filed: 2026-07-02

Period: 2026-06-29

CIK: 0001689548

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Changes in Registrant's Certifying Accountant

Item: Financial Statements and Exhibits

Documents

8-K — tm2619331d1_8k.htm (Primary)

EX-16.1 — EXHIBIT 16.1 (tm2619331d1_ex16-1.htm)

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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):

June 29, 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 4.01 Changes in Registrant's Certifying Accountant.

Dismissal of Independent Registered Public Accounting Firm

On June 29, 2026, the Audit Committee of the Board of Directors (the

"Audit Committee") of Praxis Precision Medicines, Inc. (the "Company") approved the dismissal of Ernst & Young

LLP ("EY") as the Company's independent registered public accounting firm, effective as of that date.

The reports of EY on the Company's financial statements for the fiscal

years ended December 31, 2025 and December 31, 2024 did not contain an adverse opinion or a disclaimer of opinion, and were not qualified

or modified as to uncertainty, audit scope or accounting principles.

During the fiscal years ended December 31, 2025 and December 31, 2024

and through June 29, 2026, there were no: (i) disagreements (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions)

with EY on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure, which disagreements,

if not resolved to the satisfaction of EY, would have caused it to make reference to the subject matter of the disagreements in connection

with its reports; or (ii) reportable events (as defined in Item 304(a)(1)(v) of Regulation S-K).

The Company has provided EY with a copy of the disclosures it is making

in this Current Report on Form 8-K and has requested that EY furnish a letter addressed to the Securities and Exchange Commission stating

whether it agrees with the statements made by the Company in this Current Report on Form 8-K and, if not, stating the respects in which

it does not agree. A copy of the letter from EY is attached as Exhibit 16.1 to this Current Report on Form 8-K.

Engagement of New Independent Registered Public Accounting Firm

On June 29, 2026, the Audit Committee approved the engagement of KPMG

LLP ("KPMG") as the Company's new independent registered public accounting firm, effective as of that date.

During the fiscal years ended December 31, 2025 and December 31, 2024

and through June 29, 2026, neither the Company nor anyone on its behalf has consulted with KPMG regarding: (i) the application of accounting

principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company's

financial statements, and neither a written report nor oral advice was provided to the Company by KPMG that was an important factor considered

by the Company in reaching a decision as to any accounting, auditing or financial reporting issue; or (ii) any matter that was either

the subject of a disagreement (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions) or a reportable event

(as defined in Item 304(a)(1)(v) of Regulation S-K).

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

16.1 Letter from Ernst & Young LLP to the Securities and Exchange

Commission, dated July 2, 2026.

104 Cover Page Interactive Data File (embedded within the Inline

XBRL document).

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: July 2, 2026

By:

/s/ Marcio Souza

Marcio Souza

Chief Executive Officer

EX-16.1 — EXHIBIT 16.1

EX-16.1

Filename: tm2619331d1_ex16-1.htm · Sequence: 2

Exhibit 16.1

July 2, 2026

Securities and Exchange Commission

100 F Street, N.E.

Washington, DC 20549

Commissioners:

We have read Item 4.01 of Form 8-K dated June 29, 2026, of Praxis Precision

Medicines, Inc. and are in agreement with the statements contained in the second, third and fourth paragraphs. We have

no basis to agree or disagree with other statements of the registrant contained therein.

/s/ Ernst & Young LLP

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