Praxis Shares Jump 13% on FDA Breakthrough Designation for Tremor Drug Ranks 142nd in $450M Trading Volume Amid Biotech Rally

Market Snapshot

On December 29, 2025, . , , ranking 142nd in market-wide activity. This performance followed the company’s announcement of a major regulatory milestone: the U.S. Food and Drug Administration (FDA) granted to its drug candidate ulixacaltamide for treating essential tremor. The designation, which expedites drug development and regulatory review, came after positive topline results from two pivotal Phase 3 trials. The stock’s intraday price action reflected heightened investor optimism, .

Key Drivers

The FDA’s Breakthrough Therapy Designation for ulixacaltamide marked a pivotal catalyst for Praxis’s stock surge. The designation, awarded to drugs that show substantial improvement over existing therapies for serious conditions, underscores the drug’s potential to address a significant unmet need in essential tremor (ET) treatment. ET affects approximately seven million Americans and is currently managed with limited efficacy by , a . Praxis’s Phase 3 Essential3 program demonstrated statistically significant and clinically meaningful improvements in patients’ ability to perform self-care tasks, with sustained efficacy during a randomized withdrawal phase. The FDA’s endorsement not only validates the clinical data but also fast-tracks the regulatory timeline, with Praxis planning to submit a New Drug Application (NDA) in early 2026.

The clinical and regulatory progress has reshaped investor sentiment toward Praxis. Analysts at Guggenheim and BTIG upgraded their price targets and ratings, reflecting confidence in ulixacaltamide’s commercial potential. , emphasizing the drug’s de-risked profile and the high unmet demand in ET treatment. , citing the drug’s “advantageous launch setup” and potential to build a large patient database. These upgrades, combined with the FDA’s designation, signaled to the market that Praxis is advancing a drug with both clinical and commercial differentiation.

The broader market opportunity for ulixacaltamide further amplified the stock’s rally. ET is a multi-billion-dollar commercial opportunity, . Propranolol’s limitations—poor tolerability and contraindications for comorbidities—create a gap that ulixacaltamide is positioned to fill. Praxis’s management highlighted the drug’s mechanism as a selective T-type calcium channel inhibitor, targeting abnormal neuronal firing linked to tremors. This novel approach, coupled with the FDA’s expedited pathway, strengthens the drug’s competitive positioning against existing therapies.

Beyond ulixacaltamide, Praxis’s broader pipeline and regulatory updates contributed to the stock’s momentum. The company recently announced plans to file an NDA for relutrigine in early 2026, with potential approval expected in 2027. Additionally, Praxis is reworking its EMBRAVE3 trial for elsunersen into a single-arm study, reflecting flexibility in its development strategy. These updates, while secondary to the ulixacaltamide news, reinforced the company’s ability to advance multiple programs, enhancing its appeal as a diversified biopharma player. The combination of near-term regulatory milestones and a robust pipeline has positioned Praxis as a high-conviction name in the neurology-focused biotech sector.

The market’s reaction to the news also reflected broader trends in investor behavior. Biotech stocks often experience volatile swings around regulatory decisions, and Praxis’s 13.25% gain aligns with historical patterns for companies with late-stage candidates. The surge in volume and price suggests that investors are hedging their bets on the drug’s approval likelihood, , now seemingly elevated by the FDA’s endorsement. While the company’s financials remain challenging—marked by negative margins and no revenue growth—its ability to secure regulatory milestones has shifted focus toward long-term value creation rather than short-term profitability.

In summary, Praxis’s stock rally on December 29, 2025, was driven by the FDA’s Breakthrough Therapy Designation for ulixacaltamide, bolstered by strong Phase 3 data, analyst upgrades, and the drug’s commercial potential. The designation accelerates the path to market, while the company’s broader pipeline and strategic adjustments in clinical trials further solidify its growth narrative. As the biotech sector remains sensitive to regulatory and clinical news, Praxis’s recent developments have positioned it as a focal point for investors seeking exposure to high-impact, late-stage drug candidates.