- Shares Surge: PRAX closed at $57.35 on Oct 15, 2025 and premarket on Oct 16 spiked to around $162 (a ~180% jump) after the company reported positive Phase 3 results [1] [2]. Reuters noted the news “sentits shares surging more than twofold before the bell” [3]. This gave PRAX a new 52-week high as broad investor interest poured in.
- Trial Results: The Phase 3 Essential3 program tested ulixacaltamide (PRAX-944) in essential tremor. In Study 1 (473 patients), the drug achieved a 4.3-point mean improvement in the mADL11 daily-living score at Week 8 versus placebo (p<0.0001) [4] [5]. All key secondary endpoints were also met [6]. In Study 2 (a randomized withdrawal trial), 55% of patients on ulixacaltamide maintained their response vs. 33% on placebo (p=0.0369) [7]. Ulixacaltamide was generally well tolerated: there were no drug-related serious adverse events [8] [9] (most common side effects were constipation, dizziness, “brain fog,” etc [10]). Investigators hailed the findings – co-leader Alexander Shtilbans said “these results give hope that ulixacaltamide could be widely used” in ET patients [11], and co-leader Salima Brillman noted the drug “is a real opportunity to help people regain their independence” [12].
- Regulatory Path: Praxis said it has submitted a pre-NDA meeting request to the FDA and plans to file for approval by early 2026 [13] [14]. Notably, trial patients had suffered from ET for ~30 years on average, highlighting a large unmet need [15]. If approved, ulixacaltamide would be the first targeted therapy for essential tremor (no such drugs are yet FDA-approved) [16]. The company is already planning its regulatory submission based on this data [17] [18].
- Pipeline & Milestones: Aside from ET, Praxis is pushing several CNS programs. In July 2025 the FDA granted Breakthrough Therapy status to Praxis’s PRAX-562 (relutrigine) for rare pediatric epilepsies (SCN2A and SCN8A) [19] [20]. CEO Marcio Souza called this designation “a significant milestone” for the relutrigine program [21]. Praxis’s other lead drug, vormatrigine, showed a 56.3% median seizure reduction in its Phase 2 RADIANT study [22], and Phase 3 “POWER” trials are ongoing. These developments underscore why Praxis has been burning cash: for Q2 2025 it reported a net loss of $71.1M (vs. $32.7M a year prior) [23] as R&D ramped up. However, it still had about $446–447M in cash and investments at mid-2025 [24] [25] – enough to fund operations into 2028 under current plans. The company recently ended its old $250M ATM share-sales agreement with Jefferies and launched a new $250M ATM program with TD Cowen [26] to ensure capital for these trials.
- Analyst Sentiment: Wall Street views PRAX as a high-risk, high-reward play, and sentiment turned bullish on the ET news. In early October, MarketBeat noted a “Moderate Buy” consensus (12 analysts) with an average 12-month target of $85.56 [27]. After the Phase 3 success, TipRanks reports a Strong Buy consensus (10 Buy, 1 Sell) with an average price target of $105.90 [28]. Several analysts had already been optimistic: Piper Sandler reaffirmed an Overweight (Buy) rating with a $270 target [29], HC Wainwright and Oppenheimer had $115 targets, Truist maintained a Buy at $85, while TD Cowen’s target was $61 [30]. (In contrast, Wedbush’s $33 target reflected a cautious stance.) Not all feedback was uniformly positive. For example, following the earlier epilepsy data, RBC’s Brian Abrahams pointed out the need for a “clear efficacy advantage” versus existing drugs [31]. But with ET results in hand, many experts now stress the breakthrough nature of the data. One TS2.tech roundup of 2025 neurology advances highlighted Praxis’s relutrigine breakthrough, quoting CEO Souza saying the BTD further “validates its potential” [32].
Market Outlook
With the stock now trading well above $150, investors are debating how much further PRAX could rise. If ulixacaltamide wins approval, analysts believe it could capture a sizable ET market. However, success in neurology trials can be binary – failures or setbacks could send the stock sharply down. Looking ahead, Praxis expects more data by late 2025/early 2026 (e.g. vormatrigine POWER1 topline, PRAX-562 EMBOLD readout [33] [34]). Management’s guidance (via press releases and presentations) has focused on these milestones rather than concrete revenue forecasts, which is typical for clinical-stage biotechs [35]. In the near term, analysts will scrutinize FDA feedback and the actual content of the trial data (for example, detailed efficacy and safety results). As Reuters summarized, the Phase 3 win “gives hope” for a much-needed new ET therapy [36]. Coupled with a healthy cash position and ongoing epilepsy trials, many experts now view Praxis’s prospects more favorably. Still, they caution that valuation is stretched – PRAX’s market cap (above $1.2B) reflects sky-high expectations that all these programs succeed. As of Oct. 16, 2025, the stock is riding a wave of bullish sentiment, but investors will want hard evidence from regulators and future studies before declaring victory [37] [38].
Sources: Company press releases and filings; Reuters and other news coverage [39] [40] [41] [42] [43]; analyst reports and data aggregators [44] [45] [46] [47] [48] [49]. These sources provide the factual basis for the above summary and quotes.
References
1. stockanalysis.com, 2. www.reuters.com, 3. www.reuters.com, 4. www.benzinga.com, 5. www.reuters.com, 6. www.benzinga.com, 7. www.benzinga.com, 8. in.investing.com, 9. www.benzinga.com, 10. www.benzinga.com, 11. www.reuters.com, 12. www.reuters.com, 13. in.investing.com, 14. www.reuters.com, 15. in.investing.com, 16. www.reuters.com, 17. in.investing.com, 18. www.reuters.com, 19. ts2.tech, 20. www.neurologylive.com, 21. ts2.tech, 22. www.nasdaq.com, 23. www.nasdaq.com, 24. www.nasdaq.com, 25. www.tipranks.com, 26. www.investing.com, 27. www.marketbeat.com, 28. www.tipranks.com, 29. www.investing.com, 30. www.investing.com, 31. www.biopharmadive.com, 32. ts2.tech, 33. www.nasdaq.com, 34. www.neurologylive.com, 35. www.nasdaq.com, 36. www.reuters.com, 37. www.reuters.com, 38. www.neurologylive.com, 39. www.reuters.com, 40. in.investing.com, 41. www.benzinga.com, 42. ts2.tech, 43. www.neurologylive.com, 44. www.tipranks.com, 45. www.investing.com, 46. www.marketbeat.com, 47. www.biopharmadive.com, 48. www.nasdaq.com, 49. stockanalysis.com
