Praxis Precision Medicines Inc. (NASDAQ:PRAX) shares are up on Tuesday as the company announced FDA acceptance of its New Drug Application (NDA) for ulixacaltamide HCl, a treatment for essential tremor.

Praxis Precision Medicines is a fully integrated central nervous system (CNS) precision neuroscience biopharmaceutical company, focused on genetic epilepsies.

Essential tremor is a common, often inherited, neurological disorder causing involuntary, rhythmic shaking, typically in the hands, head, or voice during movement.

The FDA has set a target action date of January 29, 2027, for ulixacaltamide, which has received Breakthrough Therapy Designation.

This announcement is seen as a significant step toward delivering a much-needed therapy for patients suffering from essential tremor.

Phase 3 Data Supports FDA Filing

The NDA is supported by positive results from the Essential3 Phase 3 program, which comprised two simultaneously enrolled pivotal studies in adults with essential tremor.

Study 1 showed a statistically significant and clinically meaningful 4.3-point mean improvement in the mADL11 score at Week 8.

In Study 2, 55% of patients in the ulixacaltamide arm maintained response versus 33% in the placebo group.

Trial Shows Significant Seizure Reduction

Last week, Praxis Precision Medicines shared results from the EMBRAVE Part A Trial of elsunersen in Patients with SCN2A Early-Onset Development and Epileptic Encephalopathy.

Praxis said elsunersen demonstrated a placebo-adjusted seizure reduction from baseline of 77% (p=0.015) in pediatric patients with SCN2A developmental and epileptic encephalopathy.

The company reported that 71% of elsunersen-treated patients achieved greater than 50% seizure reduction by period six, with efficacy sustained for up to one year in the open-label extension.

In addition, 57% of patients experienced at least a 28-day period of seizure freedom.

Technical Setup Signals Continued Momentum

Praxis Precision Medicines is currently trading near its 52-week high of $356.00, reflecting strong upward momentum. The stock is trading 11% above its 20-day simple moving average (SMA) and 7.7% above its 50-day SMA, indicating a bullish short-term trend.

The relative strength index (RSI) is at 53.43, suggesting that the stock is in neutral territory, neither overbought nor oversold. This positioning implies that there is room for further upward movement without immediate selling pressure.

  • Key Resistance: $356.00 — A critical level where selling pressure may emerge.
  • Key Support: $293.00 — A level that could provide buying interest if tested.

The stock has returned an impressive 1038.45% over the past 12 months, highlighting its strong performance and investor interest in the company’s growth prospects.

This long-term trend suggests that investors remain optimistic about the company’s future, especially with the upcoming FDA decision.

Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $588.60. Recent analyst moves include:

  • Needham: Buy (Maintains Target to $510.00) (April 14)
  • HC Wainwright & Co.: Buy (Maintains Target to $1245.00) (April 7)
  • BTIG: Buy (Maintains Target to $843.00) (April 6)

PRAX Price Action: Praxis Precision Medicine shares were up 7.15% at $339.67 at the time of publication on Tuesday. The stock is trading near its 52-week high of $355.99, according to Benzinga Pro data.

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