Praxis Precision Medicines, Inc. 8-K Filings

Praxis Precision Medicines entered a research collaboration and license agreement with Remagine Labs to develop an iontophoretic transdermal patch to deliver ulixacaltamide for essential tremor. The patch will use Remagine’s electronically controlled, multi-day dosing platform to complement Praxis’s lead oral ulixacaltamide program.

The goal of adding a transdermal option is to broaden the patient population ulixacaltamide can reach and support its competitive positioning and long-term franchise value. Praxis also made an equity investment in Remagine, reinforcing their commitment to advance this delivery approach alongside ongoing clinical development.

Praxis Precision Medicines, Inc. reported that its Audit Committee dismissed Ernst & Young LLP as independent registered public accounting firm and engaged KPMG LLP, both effective June 29, 2026. EY’s audit reports on the company’s 2024 and 2025 financial statements contained no adverse opinions or disclaimers.

The company states there were no disagreements with EY on accounting principles, financial disclosures, or audit procedures, and no reportable events during those periods. Praxis also reports that it did not consult KPMG on accounting principles, potential audit opinions, or any matters involving disagreements or reportable events before the appointment.

Praxis Precision Medicines reported that the FDA has extended by three months the review period for its New Drug Application for relutrigine, a treatment for SCN2A and SCN8A developmental and epileptic encephalopathies. The PDUFA target action date moved from September 27, 2026 to December 27, 2026.

The extension follows Praxis’s submission of additional sensitivity analyses of existing clinical data, which the FDA classified as a “major amendment,” requiring more review time. The agency did not request new clinical studies and did not raise safety or manufacturing concerns, and the review remains active. Praxis states it continues preparing for a potential relutrigine launch and remains confident in the strength of its application.

Praxis Precision Medicines reported that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for elsunersen (PRAX-222), an antisense oligonucleotide being developed to treat seizures associated with SCN2A developmental and epileptic encephalopathy caused by gain-of-function SCN2A variants.

This designation is intended to enable expedited development and regulatory review for therapies that treat serious conditions and show preliminary clinical evidence of substantial improvement over existing treatments. The decision was supported by positive topline results from the EMBRAVE Part A trial, a randomized, sham-controlled Phase 1/2 study in nine pediatric patients aged 2–12 years with early-seizure-onset SCN2A-DEE.

Praxis Precision Medicines, Inc. reported results of its 2026 Annual Meeting of Stockholders held on June 10, 2026. Stockholders elected three Class III directors — Gregory Norden, Marcio Souza and William Young — to serve until the 2029 annual meeting, with each receiving more than 21 million votes in favor.

Stockholders also ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 26,667,376 votes for and limited opposition. In an advisory, non-binding vote, stockholders approved the compensation of the company’s named executive officers, with 24,054,017 votes for and 824,318 against. No other matters were submitted for a vote.

Praxis Precision Medicines reported clinical trial results for vormatrigine in patients with focal onset seizures. In the Phase 2/3 POWER1 study in highly refractory patients, vormatrigine did not meet the primary success measure, which is a setback for this program. A key secondary measure, the 50% response rate, was met, and seizure reduction in the second half of the study at the higher 30 mg dose was more pronounced, suggesting some dose-related benefit. Vormatrigine was generally well tolerated, with adverse event-related discontinuations under 10%, and about 90% of patients from the vormatrigine arm moved into and remain in the open-label extension. The company is pausing enrollment in the POWER2 study while it reassesses the vormatrigine program and considers potential modifications.

Praxis Precision Medicines reported a first quarter 2026 net loss of $92.6 million, wider than $69.3 million a year earlier, as it ramped spending on late-stage neurology programs. Research and development expenses rose to $78.0 million, with general and administrative costs increasing to $27.9 million.

The company ended March 31, 2026 with $1.4 billion in cash, cash equivalents and marketable securities, up from $926.1 million driven mainly by a January 2026 follow-on offering, and expects this to fund operations into 2028.

FDA accepted NDAs for ulixacaltamide in Essential Tremor and relutrigine in SCN2A/SCN8A DEEs, with PDUFA target action dates on January 29, 2027 and September 27, 2026, respectively. Elsunersen achieved a 77% placebo-adjusted seizure reduction in EMBRAVE Part A, and pivotal epilepsy readouts for vormatrigine and relutrigine’s EMERALD study are expected in 2026.

Praxis Precision Medicines, Inc. reported that the U.S. Food and Drug Administration has accepted for review its New Drug Application for ulixacaltamide HCl to treat essential tremor in adults. The FDA set a target action date under the Prescription Drug User Fee Act of January 29, 2027 and indicated it is not planning to hold an advisory committee meeting.

Praxis Precision Medicines reported positive early clinical results and a key regulatory milestone in severe childhood epilepsies. In the EMBRAVE Part A Phase 1/2 trial, elsunersen produced a 77% placebo-adjusted seizure reduction from baseline and 57% of pediatric SCN2A DEE patients experienced at least a 28-day seizure-free period. All nine patients, aged 2–12 years, continued into an open-label extension where efficacy was sustained for up to one year, and all elsunersen-treated patients showed functional improvements such as better sleep, motor function, muscle tone, attention or neuropsychomotor development. Elsunersen was well-tolerated with no drug-related serious adverse events, no discontinuations and no neuroinflammation signals at doses up to 8 mg, and most treatment-emergent adverse events were mild to moderate. Separately, the FDA accepted for priority review the company’s New Drug Application for relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies, with a Prescription Drug User Fee Act target action date of September 27, 2026.

Praxis Precision Medicines reported a larger net loss for 2025 while advancing a late-stage CNS portfolio and significantly strengthening its balance sheet. The company posted a full-year net loss of $303.3 million, up from $182.8 million in 2024, driven mainly by higher research and development spending of $267.1 million as multiple programs advanced.

Cash, cash equivalents and marketable securities were $926.1 million as of December 31, 2025, compared to $469.5 million a year earlier, and together with $621.2 million in net proceeds from a January 2026 follow-on offering are expected to fund operations into 2028. The company submitted two NDAs to the FDA, for ulixacaltamide in essential tremor and relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies, and highlighted two additional late-stage programs, vormatrigine and elsunersen, with topline results expected in the first half of 2026.

Praxis Precision Medicines, Inc. filed an amended current report to update board committee assignments and its Non-Employee Director Compensation Policy, effective February 6, 2026. New directors Jeffrey B. Kindler and Stuart A. Arbuckle, previously elected as Class II directors, received formal committee roles.

Mr. Kindler was appointed to the Audit Committee and the Nominating and Corporate Governance Committee, while Mr. Arbuckle joined the Compensation Committee and the Science and Technology Committee. The amended policy provides Outside Directors a $50,000 annual cash retainer for board service plus additional annual retainers for chair and member roles on key committees, paid quarterly in arrears and prorated for partial service.

The policy also grants equity compensation under the company’s equity plan, including initial restricted stock unit awards and, when applicable, pro rata options and RSUs based on a Black-Scholes valuation and Fair Market Value, along with recurring annual option and RSU awards that vest over one or two years or accelerate upon a Sale Event.

Praxis Precision Medicines reported leadership changes. The company appointed Megan Sniecinski as Chief Operating Officer, effective January 1, 2026. She previously served as Chief Business Officer since 2021 and has held senior roles at BioCryst Pharmaceuticals, PTC Therapeutics and Merck. In connection with her new role, her annual base salary was set at $626,000 with a 2026 target bonus equal to 50% of base salary, and she will continue to participate in standard executive employment and indemnification arrangements.

The Board also elected Jeffrey B. Kindler and Stuart A. Arbuckle as independent Class II directors, each serving until the 2028 annual meeting of stockholders or until a successor is elected and qualified. Both will receive compensation under the company’s Non-Employee Director Compensation Policy, including an initial stock option award, annual cash retainer and annual stock option award. Each entered into the company’s standard indemnification agreement, and there are no related person transactions or special arrangements tied to their selection.

Praxis Precision Medicines, Inc. entered into an underwriting agreement for an underwritten public offering of 2,212,000 shares of its common stock at $260.00 per share. Underwriters were also granted an option to purchase up to 331,800 additional shares, which was exercised in full on January 7, 2026. Net proceeds from the offering are expected to be approximately $621.2 million after underwriting discounts, commissions and estimated expenses.

The company plans to use the cash, together with existing cash, cash equivalents and marketable securities, to prepare for potential commercialization of late-stage product candidates, continue research and development of clinical-stage and earlier-stage programs, and for working capital and general corporate purposes. Praxis believes this funding, combined with current resources, will be sufficient to cover operating expenses and capital expenditure requirements into 2028, although this depends on assumptions that may change.

Praxis Precision Medicines reported preliminary year-end liquidity, stating that as of December 31, 2025 its cash, cash equivalents and marketable securities totaled approximately $925 million. This figure is based on unaudited internal information and management estimates for the year and is still subject to the company’s normal year-end closing procedures.

The company emphasized that its independent registered public accounting firm has not audited or reviewed this estimate and does not provide any assurance on it. The disclosure is being furnished rather than filed, meaning it is provided for investor information but is not automatically incorporated into other securities law filings unless specifically referenced.

Praxis Precision Medicines reported multiple advances across its neurology pipeline. For ulixacaltamide, the company completed a successful pre-New Drug Application meeting with the U.S. Food and Drug Administration and gained alignment on NDA content, and now expects to finish its NDA submission in early 2026.

For relutrigine, Praxis announced positive registrational EMBOLD results in patients with SCN2A and SCN8A developmental and epileptic encephalopathies. Patients on relutrigine (n=51) achieved a 53% placebo-adjusted reduction in seizures over 16 weeks and a 66% increase in motor seizure-free days, with statistically significant improvements in clinician and caregiver global impression scores and no drug-related serious adverse events. Praxis plans to meet with the FDA and set NDA timing afterward.

For vormatrigine, full RADIANT data in focal onset seizures showed an 8-week 54% median seizure reduction, with FOS patients reaching 100% median weekly seizure reduction by week 8 and maintaining this through 16 weeks; more than 11% were seizure-free for the entire 8-week period and roughly one third for a consecutive 28-day period. Recruitment is complete for the POWER1 pivotal study in focal onset seizures, POWER2 is on track to finish in the second half of 2026, and the POWER3 monotherapy study is expected to begin in the first half of 2026.

Praxis Precision Medicines (PRAX) reported that it announced its financial results for the quarter ended September 30, 2025. The company furnished a press release detailing these results as Exhibit 99.1.

The information under Item 2.02 and Exhibit 99.1 is being furnished, not filed, under the Exchange Act and is not subject to Section 18 liability, nor incorporated by reference unless specifically stated. PRAX’s common stock trades on The Nasdaq Global Select Market under the symbol PRAX.

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.

Praxis Precision Medicines announced an underwritten equity offering of 3,025,480 shares of common stock and pre-funded warrants to purchase up to 318,470 shares. The shares were priced at $157.00 each and the pre-funded warrants at $156.9999 per underlying share, reflecting a $0.0001 exercise price. The underwriters’ 30-day option to purchase up to 501,592 additional shares was exercised in full on October 17, 2025.

All securities are being sold by the company, with expected net proceeds of approximately $567.0 million after underwriting discounts and expenses, giving effect to the option exercise. Closing is expected on October 20, 2025, subject to customary conditions. The pre-funded warrants are immediately exercisable, permit cashless exercise, include 4.99% or 9.99% beneficial ownership limits (adjustable up to 19.99% on 61 days’ notice), and will not be listed on Nasdaq. The company plans to use proceeds to advance clinical programs, prepare for potential commercialization of late-stage assets, and for working capital, stating funding into 2028 when combined with existing cash.

Praxis Precision Medicines (PRAX) reported positive topline Phase 3 results for ulixacaltamide in essential tremor. In Study 1, the placebo-controlled parallel study, ulixacaltamide produced a statistically significant and clinically meaningful improvement in the mADL11 primary endpoint at Week 8 (p<0.0001), with effects evident from Week 2 and sustained through 12 weeks. All key secondary endpoints in Study 1 reached statistical significance.

In Study 2, a randomized withdrawal design, 55% of patients continuing ulixacaltamide maintained response versus 33% on placebo (p=0.0369; OR=2.7). The first key secondary endpoint (rate of disease improvement) was significant; PGI-C and CGI-S favored ulixacaltamide numerically. Ulixacaltamide was generally well tolerated, with no deaths and no drug-related serious adverse events; common adverse events included dizziness and brain fog. The company has requested a pre-NDA meeting with the FDA and plans to submit an NDA by early 2026, upon agreement with the agency.

Praxis Precision Medicines, Inc. is reshaping its at-the-market equity financing. The company terminated its 2024 Open Market Sale Agreement with Jefferies, under which it had sold 1,368,176 shares of common stock for aggregate gross proceeds of approximately $86.2 million, with no termination penalties. As a result, no further shares will be sold under that 2024 ATM program.

The company has entered into a new 2025 Sales Agreement with TD Securities (USA) LLC (TD Cowen) to sell up to $250 million of common stock from time to time through an at-the-market offering. Praxis will set sale parameters and pay TD Cowen a commission of up to 3.0% of gross proceeds, and sales will be made under its effective shelf registration statement and related prospectus supplement.

Praxis Precision Medicines, Inc. (Nasdaq: PRAX) filed a Form 8-K detailing the voting results from its 2025 Annual Meeting held on June 26, 2025. A quorum was present and all three management proposals passed.

• Proposal 1 – Election of Class II Directors: Dr. Jeffrey Chodakewitz was elected with 14,596,188 votes for and 2,998,186 withheld; Dr. Merit Cudkowicz received 17,499,300 votes for and 95,074 withheld. Both directors will serve until the 2028 annual meeting. Broker non-votes for each nominee totaled 778,152.
• Proposal 2 – Auditor Ratification: Ernst & Young LLP was re-appointed as independent registered public accounting firm for FY 2025 with 18,358,636 votes for, 7,630 against and 6,260 abstentions (no broker non-votes).
• Proposal 3 – Say-on-Pay (advisory): Executive compensation was approved with 10,671,320 votes for, 6,919,705 against, 3,349 abstentions and 778,152 broker non-votes.

No additional matters were brought before stockholders. The filing is primarily administrative and does not disclose financial performance, transactions, or strategic changes.