Praxis Precision Medicines, INC 8-K filings

Praxis Precision Medicines reported significant advancements in its late-stage drug candidates, ulixacaltamide and relutrigine, with constructive FDA interactions and upcoming PDUFA dates, alongside a robust cash position.

Praxis Precision Medicines announces a research collaboration and license agreement with Remagine Labs to develop a transdermal patch for essential tremor treatment.

Praxis Precision Medicines announced an FDA review extension for relutrigine, pushing the target action date to December 27, 2026.

Praxis Precision Medicines stockholders re-elected three Class III directors and ratified the appointment of Ernst & Young LLP.

Praxis Precision Medicines announced its Phase 2/3 POWER1 study for vormatrigine in focal onset seizures did not meet its primary success measure, leading to a pause in enrollment for the POWER2 study.

Praxis Precision Medicines reported Q1 2026 financial results, highlighting FDA acceptance of two NDAs and positive clinical trial updates across its CNS pipeline, with substantial cash reserves extending runway into 2028.

Praxis Precision Medicines announced the FDA has accepted its New Drug Application for ulixacaltamide HCl for essential tremor.

Praxis Precision Medicines announced positive topline results from the EMBRAVE Part A trial of elsunersen for SCN2A DEE and FDA priority review acceptance for relutrigine.

Praxis Precision Medicines announced its fourth quarter and full-year 2025 financial results, highlighted by two NDA submissions and a strong cash position extending operations into 2028.

Praxis Precision Medicines, Inc. updated its non-employee director compensation policy and assigned new committee roles to recently elected board members Jeffrey B. Kindler and Stuart A. Arbuckle.

Praxis Precision Medicines announces the appointment of a new Chief Operating Officer and the election of two independent directors to its Board.

Praxis Precision Medicines, Inc. announced the pricing and full exercise of an over-allotment option in an underwritten public offering, raising approximately $621.2 million in net proceeds.

Praxis Precision Medicines, Inc. announced preliminary unaudited cash, cash equivalents, and marketable securities of approximately $925 million as of December 31, 2025.

Praxis Precision Medicines announced that the FDA granted Breakthrough Therapy Designation for ulixacaltamide for essential tremor.

Praxis Precision Medicines announced FDA agreements to streamline its elsunersen study and confirm an early 2026 NDA filing for relutrigine.

Praxis Precision Medicines announced significant progress in its clinical pipeline, including successful FDA pre-NDA alignment for ulixacaltamide and positive registrational results for relutrigine.

Praxis Precision Medicines announced positive Phase 3 results for ulixacaltamide in essential tremor, advanced other CNS programs, and secured funding into 2028.

Praxis Precision Medicines announced a Type B meeting with the FDA for ulixacaltamide in Q4 2025, following positive Essential3 topline results, and updated its corporate presentation.

Praxis Precision Medicines successfully completed an underwritten offering of common stock and pre-funded warrants, raising approximately $567 million to fund R&D and extend its cash runway into 2028.

Praxis Precision Medicines announced positive topline results from its Phase 3 Essential3 program for ulixacaltamide in essential tremor, marking a significant step towards a potential new treatment.

Praxis Precision Medicines terminates its 2024 ATM program with Jefferies and establishes a new $250 million at-the-market equity offering with TD Cowen for flexible capital raising.

Praxis Precision Medicines announced positive topline results from its RADIANT study for vormatrigine in focal onset seizures, alongside its second quarter 2025 financial results, maintaining cash runway into 2028.

A biopharmaceutical company has received breakthrough therapy designation from the FDA for its lead drug candidate targeting severe pediatric epileptic encephalopathies, signaling expedited development and review.

Praxis Precision Medicines, Inc. announced the successful election of two Class II directors, the ratification of Ernst & Young LLP as its independent auditor, and the advisory approval of executive compensation at its 2025 Annual Meeting of Stockholders.

Praxis Precision Medicines updates investors on clinical trial designs, data, and development plans for its programs targeting developmental and epileptic encephalopathies (DEEs) and essential tremor.

Praxis Precision Medicines announces Q1 2025 financial results, highlighting progress in epilepsy and DEE programs with multiple upcoming data readouts and a cash runway into 2028.

Praxis Precision Medicines stops Study 1 of its Essential3 program for essential tremor due to futility, but will continue both studies to completion, while advancing other CNS therapies and reporting a strong cash position.

Praxis Precision Medicines outlines its 2025 priorities, highlighting late-stage clinical trials and anticipated commercial launches.

Praxis Precision Medicines reports significant progress in its clinical programs, including positive results for relutrigine in DEEs and advancement of ulixacaltamide and vormatrigine, while also announcing Q3 2024 financial results.

Praxis Precision Medicines has amended employment agreements for its top executives, enhancing severance benefits, particularly in the event of a change of control.