[8-K] Praxis Precision Medicines, Inc. Reports Material Event

Rhea-AI Filing Summary

Praxis Precision Medicines (PRAX) furnished an updated corporate presentation for investor meetings and disclosed a regulatory update for ulixacaltamide. The presentation is available on its website and is furnished as Exhibit 99.1 under Item 7.01.

Separately, the company reported that the FDA, after reviewing Essential3 topline results, granted a Type B meeting for ulixacaltamide to take place in the fourth quarter of 2025. Information provided under Item 7.01 is furnished and not deemed filed under the Exchange Act.

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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): October 20, 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, 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 7.01. Regulation FD Disclosure.

On October 21, 2025, Praxis Precision Medicines, Inc. (the “Company”) updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is available in the “Investors + Media” portion of the Company’s website at investors.praxismedicines.com and a copy is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”).

The information in this Current Report under Item 7.01, 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.

Item 8.01. Other Events.

As previously disclosed, the Company submitted a pre-NDA meeting request to the U.S. Food and Drug Administration (the “FDA”) for ulixacaltamide. On October 20, 2025, the Company was informed by the FDA that, following its review of the Essential3 topline results, the FDA granted a Type B meeting to take place in the fourth quarter of 2025.

Forward-Looking Statements

This Current Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the anticipated timing of regulatory interactions for ulixacaltamide. The forward-looking statements included in this Current Report are subject to a number of risks, uncertainties and assumptions, including, without limitation, uncertainties inherent in clinical trials, the expected timing of submission for regulatory approval or review by governmental authorities and other risks as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and its other filings with the Securities and Exchange Commission. These statements are based only on facts currently known by the Company and speak only as of the date of this Current Report. As a result, you are cautioned not to rely on these forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.						Description
99.1						Praxis Precision Medicines, Inc. October 2025 Corporate Presentation
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: October 21, 2025			By:						/s/ Marcio Souza
									Marcio Souza
									Chief Executive Officer

FAQ

What did PRAX announce in its 8-K?

PRAX furnished an updated corporate presentation (Exhibit 99.1) and disclosed that the FDA granted a Type B meeting for ulixacaltamide in Q4 2025.

What is the significance of the FDA Type B meeting for PRAX (PRAX)?

It is a scheduled regulatory interaction granted after the FDA reviewed Essential3 topline results for ulixacaltamide.

When will the FDA Type B meeting occur for ulixacaltamide?

The meeting is set to take place in the fourth quarter of 2025.

Where can investors access PRAX’s updated corporate presentation?

On the company’s Investors + Media website; it is also furnished as Exhibit 99.1.

Is the corporate presentation considered filed with the SEC?

No. Under Item 7.01, it is furnished and not deemed filed under the Exchange Act.

What trial data did the FDA review related to ulixacaltamide?

The FDA reviewed the Essential3 topline results before granting the Type B meeting.