PRAX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• For our ulixacaltamide program within the Cerebrum™ platform, we submitted a New Drug Application, or NDA, for ulixacaltamide HCl for the treatment of essential tremor, or ET, to the FDA based on the positive results of our two studies in the Phase 3 Essential3 program in ET, and it was accepted for…

• For our relutrigine program within the Cerebrum™ platform, we submitted an NDA for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies, or DEEs, to the FDA based on the positive results from the registrational cohort of the EMBOLD study in SCN2A-DEE and SCN8…

• The FDA has completed its Bioresearch Monitoring, or BIMO, inspection as part of its ongoing review of the ulixacaltamide and relutrigine NDAs. The BIMO inspection was conducted jointly for both applications, and the

• scope of the inspection was comprehensive, spanning overall quality and clinical operations, data integrity, including statistical and interim analyses, and safety, amongst other standard areas in the BIMO program. The inspection was completed successfully, and no form 483 was issued.

• For our vormatrigine program within the Cerebrum™ platform, our ENERGY program is ongoing, which consists of five studies to generate patient eligibility, efficacy, safety and pharmacokinetics, or PK, data in patients with focal onset seizures, or FOS, or generalized epilepsy. Studies under the ENER…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• For our ulixacaltamide program within the Cerebrum™ platform, we announced positive topline results for the two studies in the Phase 3 Essential3 program in essential tremor, or ET, in October 2025. We submitted a New Drug Application, or NDA, for ulixacaltamide HCl for the treatment of ET to the FD…

• For our relutrigine program within the Cerebrum™ platform, in December 2025, we announced positive results from the registrational cohort of the EMBOLD study in SCN2A and SCN8A developmental and epileptic encephalopathies, or DEEs, after receiving a recommendation from the Data Monitoring Committee …

• For our vormatrigine program within the Cerebrum™ platform, our ENERGY program is ongoing, which consists of five studies to generate patient eligibility, efficacy, safety and pharmacokinetics, or PK, data in patients with focal onset seizures, or FOS, or generalized epilepsy. Studies under the ENER…

• our third efficacy study, is enrolling patients, with completion expected in the second half of 2026 and topline results expected in 2027. We intend to initiate POWER3, a clinical trial evaluating vormatrigine as a single-agent treatment for FOS, in the first half of 2026.

• For our most advanced product candidate under the Solidus™ platform, elsunersen, we announced positive topline results from the EMBRAVE Part A study evaluating the safety and efficacy of elsunersen versus sham procedure in April 2026 for treating SCN2A gain-of-function DEE. We are currently enrollin…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• However, because of the low risk profile of the instruments in our portfolio at any given time, an immediate change in market interest rates of 100 basis points would not have a material impact on our financial position or results of operations.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• On March 25, 2026, Jill DeSimone, a member of our board of directors, adopted a “Rule 10b5-1 trading arrangement” providing for the sale from time to time of an aggregate of up to 11,600 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense conditions of …