{"id":991268,"date":"2026-08-06T10:43:54","date_gmt":"2026-08-06T14:43:54","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/praxis-precision-medicines-provides-corporate-update-and-reports-second-quarter-2026-financial-results\/"},"modified":"2026-08-06T10:43:54","modified_gmt":"2026-08-06T14:43:54","slug":"praxis-precision-medicines-provides-corporate-update-and-reports-second-quarter-2026-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/praxis-precision-medicines-provides-corporate-update-and-reports-second-quarter-2026-financial-results\/","title":{"rendered":"Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2026 Financial Results"},"content":{"rendered":"
\n

\n Mid-cycle meeting completed for ulixacaltamide HCl; FDA identified no major safety or efficacy concerns to date and does not plan to request an advisory committee meeting; PDUFA date of January 29, 2027<\/em>\n <\/p>\n

\n Mid-cycle meeting completed for relutrigine; FDA identified no major safety or efficacy concerns to date and does not plan to request an advisory committee meeting; PDUFA date of December 27, 2026<\/em>\n <\/p>\n

\n FDA Bioresearch Monitoring (BIMO) inspections of Praxis for both ulixacaltamide and relutrigine completed with no Form FDA 483 observations<\/em>\n <\/p>\n

\n Commercial infrastructure build-out accelerating for ulixacaltamide HCl in Essential Tremor and relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) ahead of expected approvals<\/em>\n <\/p>\n

\n Praxis received its third Breakthrough Therapy Designation following the positive results from the EMBRAVE Part A trial of elsunersen for the treatment of seizures associated with SCN2A DEE caused by gain of function variants<\/em>\n <\/p>\n

\n Cash and investments of approximately $1.4 billion as of June 30, 2026 maintains runway into 2028<\/em>\n <\/p>\n

\n Conference call today, August 6, 2026, at 8:30am <\/em>\n <\/p>\n

BOSTON, Aug. 06, 2026 (GLOBE NEWSWIRE) — Praxis Precision Medicines<\/u><\/a>, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today provided a corporate update and reported financial results for the second quarter of 2026.<\/p>\n

\u201cThis quarter reflected meaningful progress toward becoming a multi-product commercial company, with both ulixacaltamide and relutrigine advancing closer to patients through ongoing constructive dialogue with the FDA with positive mid-cycle meetings and BIMO sponsor inspections completed for both programs. We have also taken significant steps in launch preparations: our commercial leadership is in place, we are standing up our state-of-the-art commercial systems, and the momentum is tangible with field force hiring well under way,\u201d said Marcio Souza, president and chief executive officer. \u201cAcross the rest of our portfolio, the Breakthrough Therapy Designation for elsunersen, our third in twelve months, further validates our position as a leader in CNS disease, our Solidus\u2122 ASO platform for treating devastating CNS disorders and the depth of our CNS therapeutic development engine. Lastly, we\u2019re excited to be continuing the POWER2 study with renewed conviction, informed by what we learned in POWER1, as we work to transform care for patients with focal epilepsy with vormatrigine.\u201d<\/p>\n

\n Recent Highlights and Anticipated Milestones<\/strong>
\n
\n
\n Cerebrum\u2122 for Small Molecules <\/em>
\n <\/strong>\n <\/p>\n

\n Ulixacaltamide for Essential Tremor (ET):<\/strong>\u00a0ET is one of the most common movement disorders, affecting approximately seven million patients in the U.S. Ulixacaltamide is the first and only investigational therapy to demonstrate positive results in a Phase 3 program in ET and was granted Breakthrough Therapy Designation by the FDA in December 2025.<\/p>\n