Results of Operations and Financial Condition. On August 6, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2026. A copy of the press release containing these announcements is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”).

Other Events. On July 7, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced that the Company entered into a research collaboration and license agreement (the “Agreement”) with Remagine Labs, Inc., a developer of electronically controlled transdermal drug delivery systems (“Remagine”), to develop an iontophoretic transdermal patch for the delivery of ulixacaltamide for essential tremor. Under the Agreement, the Company and Remagine will collaborate to apply Remagine’s proprietary…

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 Dece…

Other Events. On June 29, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) notified the Company that it has extended by three months the review period for its New Drug Application (“NDA”) for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (“DEEs”), setting an updated PDUFA target action date from September 27, 2026 to December 27, 2026. The extension follows the Company’s subm…

Other Events. On June 1, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced results from the Phase 2/3 POWER1 study evaluating vormatrigine in patients with focal onset seizures (“FOS”). The POWER1 study in highly refractory patients with FOS did not meet its primary success measure. The secondary measure, the 50% response rate, was met and seizure reduction during the second half of the study on higher dose (30 mg) was more pronounced. Vormatrigine was generally well-tolerated…

Results of Operations and Financial Condition. On May 7, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2026. A copy of the press release containing these announcements is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”).

Results of Operations and Financial Condition. 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 as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”). 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 deem…

Director — Jeffrey B. Kindler, Stuart A. Arbuckle: Two new directors were elected and appointed to various committees with associated compensatory arrangements.

Chief Operating Officer — Megan Sniecinski: Megan Sniecinski was promoted to Chief Operating Officer within the company.

Other Events. On January 6, 2026, Praxis Precision Medicines, Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Piper Sandler & Co., TD Securities (USA) LLC and Guggenheim Securities, LLC, as representatives of the several underwriters named in Schedule A thereto (collectively, the “Underwriters”), relating to an underwritten offering of 2,212,000 shares (the “Shares”) of the Company’s common stock, $0.0001 par value per share (the “Common Stock”)…

Results of Operations and Financial Condition. Praxis Precision Medicines, Inc. (the “Company”) is providing the following financial information. As of December 31, 2025, the Company’s cash, cash equivalents and marketable securities were approximately $925 million. The cash, cash equivalents and marketable securities information above is based on preliminary unaudited information and management estimates for the year ended December 31, 2025, is not a comprehensive statement of the Company’s…

Other Events. Elsunersen On December 9, 2025, Praxis Precision Medicines, Inc. (the “Company”) announced the completion of a Type C meeting with the U.S. Food and Drug Administration (the “FDA”) and agreement to immediately convert the EMBRAVE3 registrational study of elsunersen in early-onset SCN2A developmental and epileptic encephalopathy (“DEE”) into a single-arm study where all patients will receive elsunersen for 24 weeks, followed by an open-label extension. Key Changes to EMBRAVE3 • T…

Other Events. Ulixacaltamide On December 4, 2025, Praxis Precision Medicines, Inc. (the “Company”) announced the successful completion of its pre-New Drug Application (“NDA”) meeting with the U.S. Food and Drug Administration (the “FDA”), including receipt of written feedback and an in-person meeting. The Company has gained alignment from the FDA on the content of the NDA and expects to complete its NDA submission in early 2026. Relutrigine On December 4, 2025, the Company announced positive…

of this Current Report and Exhibit 99.1 attached hereto 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 any of it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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 R…

Other Events. On October 16, 2025, Praxis Precision Medicines, Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with TD Securities (USA) LLC, Piper Sandler & Co. and Guggenheim Securities, LLC, as representatives of the several underwriters named in Schedule A thereto (collectively, the “Underwriters”), relating to an underwritten offering of 3,025,480 shares (the “Shares”) of the Company’s common stock, $0.0001 par value per share (the “Common Stock”…

Other Events. On October 16, 2025, the Company announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor (“ET”). About the Essential3 Program Trial Design The Essential3 Phase 3 program (NCT06087276) included two simultaneously enrolled studies utilizing a decentralized design conducted within the United States, where participants were allocated to the studies in a 2:1 blinded randomization (Study 1:Study 2). Study 1 was a double-blind, parall…

Other Events. Termination of 2024 Sales Agreement As previously disclosed, on March 5, 2024, Praxis Precision Medicines, Inc. (the “Company”) entered into an Open Market Sale Agreement SM (the “Original 2024 Sales Agreement”) with Jefferies LLC (“Jefferies”), and on December 23, 2024, entered into Amendment No. 1 to the Original 2024 Sales Agreement (the “2024 Sales Agreement Amendment”, and together with the Original 2024 Sales Agreement, the “2024 Sales Agreement”) with Jefferies, pursuant…

Other Events. On August 4, 2025, the Company announced topline results from the RADIANT study evaluating vormatrigine in patients with focal onset seizures (n=37). Dosing with vormatrigine over eight weeks led to 56.3% median reduction in seizure frequency from baseline, with approximately 22% of patients reaching 100% reduction in seizure frequency in the last 28 days. Patients observed a rapid and sustained response, with approximately 60% of patients achieving 50% response in the study. Vo…

Results of Operations and Financial Condition. On August 4, 2025, Praxis Precision Medicines, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2025. A copy of the press release containing these announcements is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”). Item. 7.01. Regulation FD Disclosure. On August 4, 2025, the Company published a corporate presentation announcing topline results from its RADIANT study. The present…

Other Events. On July 17, 2025, the Company announced that the U.S. Food and Drug Administration has granted breakthrough therapy designation (the “BTD”) for relutrigine, a sodium channel functional state modulator for pediatric use for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (“DEEs”). The BTD enables expedited development and regulatory review for drugs that are intended to treat a serious condition, and preliminary clinical evidence indica…

Results of Operations and Financial Condition. On May 2, 2025, Praxis Precision Medicines, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2025. A copy of the press release containing these announcements 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 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes…

Other Events. On May 2, 2025, the Company provided updates on its programs in developmental and epileptic encephalopathies (“DEEs”) at an investor event, including: • The Company reported updated data from the initial cohort of patients with SCN2A gain-of-function and SCN8A DEEs participating in the EMBOLD study’s open-label extension as of April 2025, demonstrating a sustained and increasing effect on seizure reduction and increased seizure-free periods through 11 months of treatment with re…

Results of Operations and Financial Condition. On February 28, 2025, Praxis Precision Medicines, Inc. (the “Company”) announced its financial results for the quarter and full year ended December 31, 2024. A copy of the press release containing these announcements 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 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deem…

of this Current Report on Form 8-K (including Exhibit 99.1) 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 (the “Securities Act”), or the Exchange Act, except as expressly provided by specific reference in such a filing. Financial Disclosure Advisory…