Praxis Precision Medicines Announces Positive Pre-NDA Meeting with FDA for Ulixacaltamide in Essential Tremor

Core Insights - Praxis Precision Medicines has successfully completed its pre-NDA meeting with the FDA and expects to submit its first NDA in early 2026 [1][2] Company Overview - Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders through genetic insights [5] - The company utilizes its proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide platform, Solidus™, to address both rare and prevalent neurological disorders [5] Product Information - Ulixacaltamide is a selective small molecule inhibitor targeting T-type calcium channels, aimed at treating essential tremor by blocking abnormal neuronal activity [4] - The Essential3 program has shown statistically significant improvements in daily functioning for patients with essential tremor [2] Market Opportunity - Essential tremor affects approximately seven million people in the U.S., representing a significant commercial opportunity [3] - Current treatment options are limited, with only propranolol approved and many patients inadequately treated, highlighting the need for more effective therapies [3]