TLDR
- TD Cowen increased Praxis Precision Medicines price target to $251 from $61 following successful Phase 3 trials for ulixacaltamide HCl
- Both essential tremor studies met primary endpoints, showing improved daily activities and sustained treatment effects
- Stock jumped 183.71% after trial results were announced, with shares up 92% over six months
- Pre-NDA meeting scheduled before year-end, with New Drug Application filing expected in early 2026
- Treatment showed side effects including brain fog and dizziness that may impact market adoption
Praxis Precision Medicines received a major analyst upgrade Thursday after revealing positive clinical trial data. TD Cowen raised its price target on PRAX stock from $61 to $251.
The firm kept its Buy rating intact. Shares rocketed 183.71% following the announcement.
Praxis Precision Medicines, Inc., PRAX
The company’s experimental drug ulixacaltamide HCl met its primary endpoint in two separate Phase 3 studies. Both trials focused on essential tremor, a neurological condition that causes involuntary shaking.
PRAX stock has climbed 92% over the past six months. Year-to-date gains total 104.62%.
The first Phase 3 study measured mADL11 scores. This metric tracks modified Activities of Daily Living.
Patients taking ulixacaltamide showed statistically better improvement compared to placebo. The drug helped with everyday tasks like eating and writing.
Clinical Data Supports Regulatory Filing
The second study examined maintenance of treatment effect. Ulixacaltamide demonstrated superior ability to maintain benefits over time versus placebo.
Two successful Phase 3 trials give Praxis the data needed for FDA submission. The company plans a pre-NDA meeting with regulators before 2025 ends.
A formal New Drug Application is scheduled for early 2026. Standard FDA review typically takes 12 to 18 months.
Other analysts joined the optimistic outlook. Guggenheim set a $350 price target on PRAX stock.
Piper Sandler maintained an Overweight rating with a $270 target. Multiple firms see continued upside potential.
Side Effects May Impact Commercial Success
The drug produced side effects in clinical trials. Participants reported brain fog and dizziness during treatment.
TD Cowen flagged tolerability as a key factor for market potential. Doctors and patients will weigh tremor reduction against cognitive side effects.
This balance could determine how widely ulixacaltamide gets prescribed. Essential tremor affects millions worldwide, creating a large addressable market.
Praxis recently changed its equity financing arrangements. The company terminated its 2024 Open Market Sale Agreement with Jefferies after selling $86.2 million in shares.
A new $250 million at-the-market offering program launched with TD Cowen. This provides capital as Praxis advances toward potential commercialization.
The company also develops vormatrigine for epilepsy. That candidate showed positive Phase 2 results.
PRAX stock currently trades with a market cap of $3.42 billion. Average daily volume sits at 672,694 shares.
Technical indicators show a buy signal. The stock demonstrates high volatility alongside strong price momentum.
Praxis expects its pre-NDA meeting with the FDA before the end of this year, with the New Drug Application submission targeted for the first quarter of 2026.