Praxis Precision Medicines (PRAX) Stock Soars as Tremor Drug Clears Key Clinical Milestone

TLDR

• TD Cowen raised Praxis Precision Medicines price target from $61 to $251, maintaining a Buy rating after strong Phase 3 results
• Ulixacaltamide HCl met primary endpoints in both essential tremor studies, showing improved daily living activities and maintained treatment effects
• The stock has jumped over 92% in the past six months and surged 183.71% recently following the trial data announcement
• Company plans pre-NDA meeting before year-end with New Drug Application submission targeted for early 2026
• Side effects including brain fog and dizziness will need to be balanced against efficacy when determining market potential

TD Cowen delivered a major vote of confidence for Praxis Precision Medicines on Thursday, raising its price target from $61 to $251. The firm maintained its Buy rating on the stock.

Praxis Precision Medicines, Inc., PRAX

The dramatic increase came after the company announced positive Phase 3 clinical trial results for ulixacaltamide HCl, its experimental treatment for essential tremor. The drug met its primary endpoint in both studies.

Shares responded with force. The stock surged 183.71% following the announcement.

Over the past six months, PRAX has climbed more than 92%. That’s a remarkable run by any measure.

The company ran two separate Phase 3 studies. In the first trial, ulixacaltamide showed statistically improved results in mADL11, which measures modified Activities of Daily Living.

The drug outperformed placebo in helping patients with everyday tasks. The second study focused on maintenance of effect.

Results showed ulixacaltamide maintained its treatment benefits over time better than placebo. These outcomes give Praxis two successful Phase 3 trials to support its regulatory filing.

Essential tremor affects millions of people worldwide. The condition causes involuntary shaking that can interfere with eating, writing, and other basic activities.

Current treatment options remain limited. A new therapy that works could tap into a large patient population.

FDA Submission Timeline Takes Shape

Praxis plans to meet with the FDA for a pre-NDA discussion before the end of 2025. The company aims to submit its New Drug Application in early 2026.

That timeline puts potential FDA approval roughly 12 to 18 months away, assuming a standard review process. TD Cowen’s new price target reflects optimism about the drug’s commercial prospects.

The $251 target represents more than a 300% increase from the previous $61 figure. Guggenheim went even higher, setting a $350 price target.

Piper Sandler maintained an Overweight rating with a $270 target. Multiple firms see upside from current levels.

Balancing Efficacy Against Side Effects

The drug isn’t without concerns. Trial participants reported side effects including brain fog and dizziness.

These tolerability issues could affect how widely ulixacaltamide gets prescribed. TD Cowen noted that balancing the side effect profile against efficacy will be critical.

Doctors and patients will weigh the tremor reduction benefits against cognitive and balance-related complaints. That calculus will determine market uptake.

The company also has other programs in development. Vormatrigine, a treatment for epilepsy, showed positive Phase 2 data.

Praxis recently terminated its 2024 Open Market Sale Agreement with Jefferies. The company had sold approximately $86.2 million in shares under that program.

It initiated a new $250 million at-the-market equity offering with TD Cowen. The financing gives Praxis additional resources as it moves toward commercialization.

Current market cap stands at $3.42 billion. Average daily trading volume is 672,694 shares.

The stock has gained 104.62% year-to-date. Technical indicators currently show a buy signal.

The company expects to hold its pre-NDA meeting with regulators before year-end, with the formal application submission planned for the first quarter of 2026.

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