Praxis Precision Medicines Inc. (NASDAQ:PRAX) is one of the Reddit stocks that will go to the moon. On October 16, Praxis Precision Medicines announced positive topline results for its pivotal Phase 3 Essential3 program for ulixacaltamide in essential tremor/ET. Ulixacaltamide is a differentiated, highly selective small molecule inhibitor of T-type calcium channels designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical/CTC circuit.
The announcement is significant because ET is the most common movement disorder, affecting ~7 million people in the US, and current treatment options are limited in efficacy and tolerability, leading to an estimated minimum of 2 million patients actively seeking better treatment. Patients in the Essential3 program had been living with ET for an average of 30 years, underscoring the high unmet need; over 200,000 people were interested in participating in the study.
The Essential3 Phase 3 program included two simultaneously enrolled studies utilizing a decentralized, home-based design across all 50 states in the US. Praxis has submitted a pre-NDA meeting request to the FDA and plans to submit the NDA by early 2026, pending agreement with the agency.
Praxis Precision Medicines Inc. is a clinical-stage biopharmaceutical company that develops therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance.
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This article is originally published at Insider Monkey.
