Praxis Shares Rise on FDA Path for Essential Tremor Drug
The company announced a successful pre-New Drug Application meeting with regulators for its novel treatment, ulixacaltamide, targeting a multi-billion dollar market.
Shares of Praxis Precision Medicines Inc. (NASDAQ: PRAX) advanced in trading after the company announced it had completed a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration for its lead drug candidate, ulixacaltamide, a potential treatment for essential tremor.
The stock climbed approximately 2.1% to $189.97 in recent trading sessions, pushing the company’s market capitalization to over $4.6 billion. The positive regulatory feedback marks a significant milestone for Praxis, providing a clearer pathway toward commercialization for a drug aimed at a condition affecting an estimated seven million people in the United States.
According to a company announcement, Praxis has reached an alignment with the FDA on the substance and format of its NDA submission. This critical step de-risks the regulatory process and sets a timeline for the formal application, which the company expects to file in the first half of 2026.
Essential tremor is a neurological disorder that causes involuntary, rhythmic shaking, most often in the hands, and currently has limited effective treatment options. Many existing therapies are older drugs repurposed for the condition, often carrying significant side effects that limit their use. Ulixacaltamide, a novel small molecule, has been designed specifically to address the underlying neuronal imbalance believed to cause the condition.
The drug previously demonstrated significant improvement in tremor control and daily functioning in its pivotal Phase 3 clinical trial, known as the Essential3 program. The successful trial results, combined with the recent FDA alignment, have bolstered investor and analyst confidence in the drug's potential.
Analysts are projecting a substantial market opportunity for an effective new treatment. According to research from AInvest, which called the drug a potential "game-changer," peak sales estimates for ulixacaltamide exceed $2.5 billion. The broader market for essential tremor treatments is projected to reach $2.3 billion by 2033, highlighting the significant commercial potential.
Wall Street has responded favorably to the drug's progress. Following the positive clinical data, analysts at LifeSci Capital reiterated a "Buy" rating on Praxis with a price target of $383.00, citing the drug's promising efficacy and manageable side effect profile. The consensus analyst target price for the company stands at $323.93, suggesting considerable upside from its current valuation.
The Boston-based biopharmaceutical firm is focused entirely on central nervous system disorders. The advancement of ulixacaltamide is central to its growth strategy and its mission to develop transformative therapies for conditions with high unmet needs.
As Praxis prepares for its NDA submission in 2026, investors will be closely watching for further updates on manufacturing readiness and commercial strategy. The successful pre-NDA meeting provides the company with a clear runway to bring a potentially best-in-class treatment to a large and underserved patient population.