Praxis Advances Essential Tremor Program After Successful FDA Pre-NDA Meeting And Expects Early 2026 Submission

Praxis Precision Medicines announced that it has successfully completed its pre-NDA meeting with the U.S. FDA, receiving both written guidance and in-person feedback. The company confirmed that it has secured alignment with regulators on the components of its upcoming New Drug Application and is preparing to submit the NDA in early 2026. This marks an important regulatory milestone for Praxis as it advances a potential new therapy for essential tremor (ET).

Essential tremor is the most common movement disorder, affecting approximately seven million people in the U.S. and representing a significant commercial and clinical opportunity. ET is characterized by involuntary rhythmic shaking, primarily in the upper limbs, but it can also affect the head, voice, or legs. These tremors progressively worsen, often interfering with daily tasks and quality of life. Despite its prevalence, current therapeutic options remain limited.

“We are very pleased with the collaborative discussions we recently had with the FDA and remain on track to submit Praxis’ first NDA in early 2026. Building on the strong momentum from the positive Essential3 program, where ulixacaltamide demonstrated statistically significant and clinically meaningful improvements in daily functioning, the FDA feedback moves us closer to delivering a much-needed therapy to the millions of people living with essential tremor who currently lack effective and safe treatment options,” said Marcio Souza, president and chief executive officer.

Propranolol is currently the only FDA-approved medication for ET, though its efficacy is modest and its tolerability profile restricts its use, especially in patients with certain comorbidities. Other treatments such as additional beta-blockers and anti-convulsants are used off-label, but they too suffer from limited benefit and side-effect challenges. As a result, a large portion of patients remain undertreated or untreated.

Surveys indicate that up to 77% of patients feel their ET is not adequately managed, and as many as half are receiving no treatment at all. Neurologists report that 85% of their patient visits involve individuals seeking help for ET symptoms, yet 40% of those patients are without a therapeutic regimen. These data highlight the urgent need for safer, more effective, and tolerable therapies, a gap Praxis aims to address through its upcoming NDA submission.