Praxis Precision Medicines (PRAX) Soars on FDA Momentum and 760-Dollar Target: December 9, 2025 Stock Deep Dive

Praxis Precision Medicines (PRAX) Soars on FDA Momentum and 760-Dollar Target: December 9, 2025 Stock Deep Dive

Praxis Precision Medicines, Inc. (NASDAQ: PRAX) has turned into one of 2025’s most dramatic biotech stories. On December 9, 2025, the stock is trading around $265–270 per share, near its 52‑week high of about $278 and far above its low near $26.70, giving the company a market capitalization of roughly $6.6 billion. [1]

Behind that move is a mix of powerful late‑stage clinical data, accelerating FDA interactions, increasingly aggressive analyst targets — including a new $760 price target from Guggenheim — and a growing cloud of controversy after a short‑seller attack on Praxis’s lead program. [2]

Here is a detailed, news-style look at PRAX stock as of December 9, 2025, pulling together the latest price action, clinical milestones, analyst forecasts, institutional flows, and risks that could shape the next leg of this volatile biotech rally.


PRAX Stock Today: From Penny Territory to a Multi‑Billion Dollar Biotech

As of the morning of December 9, 2025, Praxis shares are changing hands at roughly $265 after opening around $271, with an intraday range that has already reached above $278. Over the last 12 months, the stock has traded between about $26.70 and $278.00, while its three‑month move has been extraordinary: Zacks estimates a roughly 520% gain over that period, with about 270% appreciation over the past year. [3]

Key snapshot metrics from recent quote services:

  • Price: about $265–270 (Dec 9, 2025, intraday) [4]
  • Market cap:$6.6 billion [5]
  • 52‑week range:$26.70 – ~$278 [6]
  • Beta: around 3, underscoring extreme volatility [7]
  • TTM revenue: roughly $7–9 million versus a net loss above $180–270 million [8]

In other words, PRAX is now priced like a high‑conviction late‑stage biotech: little current revenue, large losses, and a valuation driven mainly by expectations for future blockbuster drugs rather than today’s fundamentals.


The Engine of the Rally: Ulixacaltamide’s Essential Tremor Breakthrough

First successful Phase 3 program in essential tremor

The spark for PRAX’s massive re‑rating came on October 16, 2025, when Praxis reported positive topline results from its Phase 3 Essential3 program for ulixacaltamide, a T‑type calcium channel blocker for essential tremor (ET). [9]

In the main placebo‑controlled study (Study 1):

  • Patients on ulixacaltamide saw a 4.3‑point mean improvement from baseline at Week 8 on the mADL11 (Modified Activities of Daily Living, 11‑item) scale, compared with a smaller change on placebo, achieving high statistical significance. [10]
  • Benefits emerged as early as Week 2 and were sustained over 12 weeks. [11]
  • Key secondary endpoints, including global impression measures, were also reported as statistically significant. [12]

In Study 2, a randomized withdrawal design:

  • Responders who stayed on ulixacaltamide maintained benefit more often than those switched to placebo (about 55% vs 33%, respectively). [13]

The company and multiple analysts have highlighted these data as the first clearly positive Phase 3 program for a drug in development for essential tremor, a condition affecting millions of patients with limited effective treatment options. [14]

Positive pre‑NDA meeting and 2026 filing timeline

The story accelerated further in early December when Praxis confirmed it had completed a pre‑New Drug Application (pre‑NDA) meeting with the FDA for ulixacaltamide and secured agency alignment on the content and requirements of a planned NDA. [15]

  • Praxis now plans to submit the ulixacaltamide NDA in early 2026, positioning it as the company’s first potential commercial product. [16]
  • Analysts at Zacks and others see this regulatory progress as a key justification for the stock’s multi‑hundred‑percent move over the last three months. [17]

For investors and regulators, the central question is now less whether ulixacaltamide improves ET symptoms — the Phase 3 data are undeniably strong — and more how the FDA will weigh the statistical and methodological concerns that have since surfaced (more on that below).


Second Growth Engine: Relutrigine for Catastrophic Epilepsies

While ulixacaltamide drives the ET franchise, Praxis has also reported headline‑grabbing results in epilepsy, giving PRAX a potential dual blockbuster narrative.

EMBOLD trial: early stop for efficacy

In early December, the company announced that the registrational cohort of the EMBOLD study evaluating relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) was stopped early after an interim analysis met efficacy endpoints. [18]

Key points from Zacks and Investors Business Daily coverage and company updates:

  • Patients on relutrigine achieved about a 27% reduction in seizures over 28 days versus roughly 2% with placebo in earlier data, framing the drug as potentially transformative for these devastating, treatment‑resistant epilepsies. [19]
  • Praxis plans to present topline EMBOLD results at the American Epilepsy Society annual meeting in December 2025 and has an upcoming FDA meeting to discuss the regulatory path. [20]

Analyst view: blockbuster potential and accelerated timelines

H.C. Wainwright, in a December 5 note, raised its price target on PRAX to $340 from $258 and increased its probability of success for relutrigine to 80% from 60%, boosting projected peak sales from about $760 million to $2.8 billion. [21]

The firm suggested that, given Breakthrough Therapy Designation and strong data, relutrigine could receive priority review and potentially be approved as early as 2026, with ulixacaltamide close behind — implying a scenario where Praxis could have two major CNS drugs approved within months of each other if all goes well. [22]

Praxis is also running the EMERALD study to extend relutrigine into a broader DEE population, with completion expected in the second half of 2026, which could support a supplemental NDA in 2027. [23]


Street Sentiment: From Niche Biotech to High‑Conviction Story

New 760‑dollar target from Guggenheim and a wall of “Buy” ratings

The most eye‑catching headline today is from QuiverQuant’s analyst-tracking feed: Guggenheim’s Yatin Suneja just set a $760 price target on PRAX, the highest on the Street. [24]

According to the same dataset, in just the last week multiple firms have issued or raised targets:

  • Truist: $500, Buy (Dec 8) [25]
  • BTIG: $507, Buy (Dec 8) [26]
  • Needham: $315, Buy (Dec 8) [27]
  • TD Cowen: $353, Buy (Dec 8) [28]
  • HC Wainwright: $340, Buy (Dec 5) [29]
  • Piper Sandler: $450, Overweight, after pre‑NDA and EMBOLD wins (Dec 5) [30]
  • Wedbush: $83, Underperform — a notable outlier on the bearish side. [31]

Across different data providers:

  • QuiverQuant: median 12‑month target $315 across 13 analysts in the last six months. [32]
  • StockAnalysis: average target about $293.71 with a “Strong Buy” consensus. [33]
  • MarketBeat: average targets reported in the $292–$323 range, with a “Moderate Buy” rating from roughly 16 analysts (2 Strong Buy, ≈12–13 Buy, 2 Sell). [34]
  • Investing.com: cites an average target near $373, with a high of $760 and low of $83, and describes overall sentiment as “Strong Buy” with ~40% upside from current levels. [35]

The exact averages differ by data source and timing, but the pattern is clear: Wall Street is overwhelmingly bullish, with targets clustering a bit above the current price and a handful of extremely optimistic calls that assume multi‑billion‑dollar peak sales across both ET and epilepsy franchises.

Zacks and other research: rally justified but classified as “Hold”

Not every research lens screams “back up the truck.”

Zacks, for example, currently assigns PRAX a Rank #3 (Hold) even while acknowledging the more than 500% gain in three months and underlining the strength of recent Phase 3 and epilepsy data. [36]

That more cautious classification highlights a key point: much of PRAX’s move has now priced in good outcomes, so further upside may depend on clean regulatory reviews, sustained data robustness, and commercial execution.


Fresh Institutional Flows: Swiss National Bank, Vivo Capital, and B Group Add Exposure

On December 9, several new institutional filings hit the tape, adding another layer to the bullish narrative.

Swiss National Bank

  • Increased its PRAX holdings by 13.7% in Q2, now owning about 30,800 shares (≈0.15% of the company), valued at roughly $1.3 million at quarter‑end. [37]

Vivo Capital

  • Opened a new position of 167,600 shares, worth about $7.05 million, making PRAX around 0.7% of its portfolio and giving Vivo a roughly 0.8% stake in the company. [38]

B Group Inc.

  • Boosted its stake by 84.2% to 35,000 shares, now about 1.1% of its portfolio and 0.17% of Praxis’s equity. [39]

MarketBeat’s aggregated data indicate that institutional investors and hedge funds now own roughly 68% of PRAX’s outstanding shares, underscoring that the story has moved firmly into the institutional growth‑biotech bucket. [40]

At the same time, there has been substantial insider and fund selling — notably by long‑time holders like Adage and by company insiders including General Counsel Alex Nemiroff and accounting officer Lauren Mastrocola. QuiverQuant estimates 16 open‑market sales and zero insider purchases over the last six months, including tens of millions of dollars in stock sold by Adage and senior executives. [41]


The Shadow Over the Story: Culper’s Short Report and Trial Design Questions

The bull case on PRAX is powerful, but the stock has not climbed in a straight line. On November 20, 2025, short‑seller Culper Research published a detailed report accusing Praxis of “engineering” its ulixacaltamide Phase 3 success. [42]

Key allegations include:

  • Last‑minute primary endpoint change: Culper argues that Praxis changed the Essential3 primary endpoint from a Day‑84 assessment to Day 56 “at the last minute,” allegedly without explicit FDA sign‑off. [43]
  • Handling of dropouts: The report criticizes the statistical treatment of high dropout rates, claiming that the imputation methods used for about one‑third of treated patients inflated ulixacaltamide’s apparent benefit. [44]
  • Regulatory risk: Culper suggests that, given the endpoint change and other design concerns, the drug may face a tough reception at the FDA and could ultimately fail to win approval, despite the company’s robust topline narrative. [45]

The report triggered a sharp pullback in the stock on publication day, and prompted a flurry of commentary from financial media, including coverage by Benzinga, Investing.com and others. [46]

Praxis’s response: fireside chat and sensitivity analyses

Praxis has pushed back, hosting a fireside chat on November 24, 2025 with external experts to discuss Essential3 design, statistical modeling, and sensitivity analyses. According to summary coverage, management emphasized that:

  • The study remained positive at multiple time points, including at the original later assessment. [47]
  • A delta‑adjusted “tipping point” analysis was used to stress‑test the impact of non‑random dropouts, with results still meeting conventional robustness thresholds. [48]

Nevertheless, the regulatory lens on the ET program is now sharper. Several sell‑side analysts — including Wedbush and Needham — have explicitly flagged the possibility of an FDA advisory committee and assign less than 50% probability to ultimate ulixacaltamide approval despite acknowledging the apparently strong efficacy data. [49]

In short: Praxis’s science is compelling enough to generate huge upside expectations, but the path to approval is no longer perception‑risk‑free.


Valuation and Forecast: What the Numbers Signal as of December 9, 2025

At around $265–270 per share, PRAX trades at:

  • A market cap near $6.6–6.8 billion [50]
  • With trailing‑twelve‑month revenue under $10 million and losses well above $180 million per year. [51]

This is classic late‑stage biotech territory: valuation is dominated by discounted expectations for future cash flows from ulixacaltamide and relutrigine rather than current earnings.

Based on the range of published forecasts:

  • Consensus price targets across platforms cluster in the roughly $290–$320 range. [52]
  • More aggressive models (e.g., Investing.com and Guggenheim) imply mid‑$300s averages or even $760 at the high end, assuming blockbuster peak sales and relatively high probabilities of success in both ET and DEE. [53]

Given that:

  • A single failed regulatory decision — particularly for ulixacaltamide — could wipe out a large portion of the current market cap, while
  • Parallel success in two indications with high unmet need could make today’s valuation look conservative,

the risk/reward profile remains extremely skewed. This is not a steady compounder; it’s a binary, trial‑and‑FDA‑driven equity.

Most research notes explicitly stress this point, and several outlets — including H.C. Wainwright and Zacks — remind readers that their commentary is not investment advice and should be weighed against individual risk tolerance. [54]


Key Catalysts to Watch Into 2026

For investors and observers following Praxis Precision Medicines after December 9, 2025, the main forward‑looking milestones are:

  1. Ulixacaltamide NDA submission (early 2026)
    • Praxis plans to file its ET NDA in early 2026, following a positive pre‑NDA meeting. The critical unknowns are how FDA reviewers will assess the endpoint change, dropout handling, and overall risk–benefit profile highlighted by both bulls and short‑sellers. [55]
  2. EMBOLD full data and FDA meeting for relutrigine
    • Detailed EMBOLD efficacy and safety results will be presented at the American Epilepsy Society meeting, followed by a regulatory strategy discussion with the FDA. Analysts see potential for Breakthrough‑enabled priority review and relatively fast timelines given the severe unmet need. [56]
  3. EMERALD trial progress and broader epilepsy expansion
    • Readouts and updates from the EMERALD program in a broader DEE population, expected in 2H 2026, could support relutrigine’s life‑cycle expansion and materially affect long‑term revenue projections. [57]
  4. Regulatory and legal overhangs
    • Short‑seller allegations, shareholder law‑firm investigations, and any future regulatory commentary around trial conduct could impact sentiment sharply in either direction. [58]
  5. Additional financing or partnerships
    • Following its $525 million public offering in October, Praxis has more cash to fund its pipeline, but commercial launches and larger Phase 3 programs may still require partnerships or additional capital, which could be either a de‑risking event or a dilutive one depending on structure and timing. [59]

Bottom Line: A Biotech Lightning Rod at the Center of 2025’s Risk Trade

As of December 9, 2025, Praxis Precision Medicines is one of the most talked‑about biotech stocks in the market:

  • It has delivered rare Phase 3 successes in essential tremor and promising registrational data in catastrophic epilepsies. [60]
  • The company has completed a positive pre‑NDA meeting and is preparing its first major filing. [61]
  • Wall Street has responded with a wave of aggressive buy ratings and price targets, including a headline‑grabbing $760 call from Guggenheim. [62]
  • At the same time, Culper’s short report and ongoing scrutiny of trial design have injected substantial regulatory and reputational risk into the story. [63]

For now, PRAX sits at the intersection of breakthrough science, ambitious valuation, and intense debate — a textbook case of late‑stage biotech where fortunes will likely hinge on a small number of FDA decisions over the next 12–24 months.

References

1. stockanalysis.com, 2. www.quiverquant.com, 3. stockanalysis.com, 4. stockanalysis.com, 5. www.investing.com, 6. stockanalysis.com, 7. stockanalysis.com, 8. stockanalysis.com, 9. ir.praxismedicines.com, 10. www.nasdaq.com, 11. www.nasdaq.com, 12. www.sec.gov, 13. www.nasdaq.com, 14. www.praxisessentialtremor.com, 15. stockanalysis.com, 16. www.nasdaq.com, 17. www.nasdaq.com, 18. stockanalysis.com, 19. www.investors.com, 20. stockanalysis.com, 21. www.investing.com, 22. www.investing.com, 23. www.nasdaq.com, 24. www.quiverquant.com, 25. www.marketbeat.com, 26. www.quiverquant.com, 27. www.marketbeat.com, 28. www.quiverquant.com, 29. www.investing.com, 30. www.insidermonkey.com, 31. www.investors.com, 32. www.quiverquant.com, 33. stockanalysis.com, 34. www.marketbeat.com, 35. www.investing.com, 36. www.nasdaq.com, 37. www.marketbeat.com, 38. www.marketbeat.com, 39. www.marketbeat.com, 40. www.marketbeat.com, 41. www.quiverquant.com, 42. culperresearch.com, 43. culperresearch.com, 44. culperresearch.com, 45. www.investing.com, 46. www.investing.com, 47. www.sec.gov, 48. www.sec.gov, 49. www.investors.com, 50. www.marketbeat.com, 51. stockanalysis.com, 52. www.marketbeat.com, 53. www.quiverquant.com, 54. www.investing.com, 55. www.nasdaq.com, 56. www.investing.com, 57. www.nasdaq.com, 58. stockanalysis.com, 59. stockanalysis.com, 60. www.sec.gov, 61. stockanalysis.com, 62. www.quiverquant.com, 63. culperresearch.com

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