Recent Updates — PRAX
Praxis Precision Medicines, Inc. entered into a research collaboration and license agreement with Remagine Labs, Inc. to develop an iontophoretic transdermal patch for delivering ulixacaltamide for essential tremor. The partnership involves applying Remagine's proprietary platform to ulixacaltamide to complement its lead oral program and broaden the patient population. Praxis Precision Medicines, Inc. is a biotechnology company focused on developing precision medicine for neurological disorders.
On June 29, 2026, the Audit Committee of Praxis Precision Medicines, Inc. dismissed Ernst & Young LLP (EY) as its independent registered public accounting firm, effective immediately. The company has engaged KPMG LLP as its new independent registered public accounting firm, effective the same date. Previous audit reports from EY for the fiscal years 2024 and 2025 were not adverse, disclaimed, or qualified. Praxis Precision Medicines, Inc. is a biotechnology company focused on developing precision medicines for neurological disorders.
Praxis Precision Medicines, Inc. announced on June 29, 2026, that the FDA has extended the review period for its relutrigine New Drug Application (NDA) for treating SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) by three months. The updated PDUFA target action date is now December 27, 2026, following the FDA's classification of the Company's additional sensitivity analyses as a
Praxis Precision Medicines, Inc. announced on June 22, 2026, that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for elsunersen (PRAX-222), an antisense oligonucleotide intended to treat seizures associated with SCN2A Developmental and Epileptic Encephalopathy (DEE). The designation is supported by preliminary clinical evidence from the EMBRAVE Part A trial, a Phase 1/2 study in pediatric patients. Praxis Precision Medicines, Inc. is a biopharmaceutical company focused on the development of medicines for neurological disorders.