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PRAX Stock Skyrockets 520% in 3 Months: Here's What You Need to Know
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Key Takeaways
PRAX surged on pivotal Essential3 results showing ulixacaltamide met all key endpoints in essential tremor.
Efficacy appeared early and was sustained, with Study 2 confirming a maintained response versus placebo.
Progress on pre-NDA steps and positive relutrigine data added further fuel to PRAX's recent stock rally.
Shares of Praxis Precision Medicines (PRAX - Free Report) have skyrocketed 519.5% in the past three months. The sharp rally in the stock was largely fueled by encouraging top-line data from two pivotal late-stage studies of PRAX’s lead candidate, ulixacaltamide, from the Essential3 program for essential tremor (ET), reported in mid-October 2025.
More on PRAX’s Phase III Essential Tremor Study Data
Praxis’ phase III Essential3 program delivered a strong efficacy signal for ulixacaltamide across both late-stage studies in ET, meeting all primary endpoints and most key secondary measures. In the placebo-controlled parallel-group study (Study 1), patients treated with ulixacaltamide achieved a statistically significant and clinically meaningful 4.3-point mean improvement from baseline in the Modified Activities of Daily Living 11 (mADL11) score at Week 8, the pre-specified primary endpoint. Notably, treatment effects emerged as early as Week 2 and were sustained throughout the 12-week dosing period, underscoring both the rapid onset and durability of benefit.
Study 1 also showed consistent benefits across all key secondary endpoints, with ulixacaltamide outperforming placebo on measures of disease improvement as well as patient- and clinician-reported outcomes. Sensitivity and robustness analyses, including imputation of missing data and later timepoint assessments, reinforced the reliability of the primary outcome, with treatment effects remaining significant under conservative assumptions.
The randomized withdrawal Study 2 further validated ulixacaltamide’s therapeutic impact by demonstrating superior maintenance of response. After an initial 8-week ulixacaltamide treatment phase, 55% of the responders who continued to receive the candidate for an additional four weeks maintained response compared to 33% of patients who were switched to placebo. The first key secondary endpoint, rate of disease improvement, also significantly favored ongoing ulixacaltamide therapy. While additional secondary measures, such as patient- and clinician-reported outcomes, trended in favor of the candidate, they did not reach statistical significance.
In the past year, shares of Praxis have surged 272.6% compared with the industry’s 9.2% growth.
Image Source: Zacks Investment Research
Cross-study analyses strengthened the overall efficacy profile, showing robust improvements in mADL11 when ulixacaltamide-treated patients across both studies were compared with placebo. From a safety standpoint, ulixacaltamide was generally well tolerated, with a profile consistent with previous studies. Treatment-related adverse events were mostly mild in severity.
Other Factors Potentially Driving PRAX Stock Price Rally
Last week, Praxis reported the successful completion of its pre-new drug application (NDA) meeting with the FDA for ulixacaltamide to treat ET, with the agency aligning on the content of the impending NDA. The company received written feedback and held an in-person discussion, clearing a key regulatory step and reinforcing momentum from the successful phase III Essential3 program. Praxis now plans to submit its NDA in early 2026, positioning ulixacaltamide as a potential new treatment option in a market with limited effective therapies. Subject to its acceptance, the ulixacaltamide NDA could become PRAX’s first regulatory application under FDA review. This has also likely contributed to the stock price rally in the past three months.
Another catalyst likely underpinning the stock price surge is Praxis’ encouraging progress with relutrigine, another late-stage central nervous system asset. The company recently reported positive results from the registrational cohort of the EMBOLD study in patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEE), with positive data from an interim analysis triggering an early stop for efficacy. The data marks a meaningful milestone in a high-unmet-need, no-approved-therapy setting.
Importantly, the FDA has confirmed an upcoming meeting to review the results and discuss the regulatory path forward, adding near-term clarity on next steps. Praxis refrained from commenting on the timeline for filing an NDA for relutrigine to treat the DEE indication until then. PRAX previously reached an agreement with the FDA that positive EMBOLD study results could serve as substantial evidence of effectiveness for a potential NDA.
Beyond this, relutrigine’s opportunity extends into a broader DEE population through the ongoing registrational EMERALD study, which is expected to be completed in the second half of 2026 and could support a supplemental NDA by 2027 if successful.
Praxis Precision Medicines, Inc. Price and Consensus
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has gained 13% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.78 to $8.15. In the past year, shares of ANIP have rallied 40.9%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. In the past year, shares of ARQT have surged 148%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
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PRAX Stock Skyrockets 520% in 3 Months: Here's What You Need to Know
Key Takeaways
Shares of Praxis Precision Medicines (PRAX - Free Report) have skyrocketed 519.5% in the past three months. The sharp rally in the stock was largely fueled by encouraging top-line data from two pivotal late-stage studies of PRAX’s lead candidate, ulixacaltamide, from the Essential3 program for essential tremor (ET), reported in mid-October 2025.
More on PRAX’s Phase III Essential Tremor Study Data
Praxis’ phase III Essential3 program delivered a strong efficacy signal for ulixacaltamide across both late-stage studies in ET, meeting all primary endpoints and most key secondary measures. In the placebo-controlled parallel-group study (Study 1), patients treated with ulixacaltamide achieved a statistically significant and clinically meaningful 4.3-point mean improvement from baseline in the Modified Activities of Daily Living 11 (mADL11) score at Week 8, the pre-specified primary endpoint. Notably, treatment effects emerged as early as Week 2 and were sustained throughout the 12-week dosing period, underscoring both the rapid onset and durability of benefit.
Study 1 also showed consistent benefits across all key secondary endpoints, with ulixacaltamide outperforming placebo on measures of disease improvement as well as patient- and clinician-reported outcomes. Sensitivity and robustness analyses, including imputation of missing data and later timepoint assessments, reinforced the reliability of the primary outcome, with treatment effects remaining significant under conservative assumptions.
The randomized withdrawal Study 2 further validated ulixacaltamide’s therapeutic impact by demonstrating superior maintenance of response. After an initial 8-week ulixacaltamide treatment phase, 55% of the responders who continued to receive the candidate for an additional four weeks maintained response compared to 33% of patients who were switched to placebo. The first key secondary endpoint, rate of disease improvement, also significantly favored ongoing ulixacaltamide therapy. While additional secondary measures, such as patient- and clinician-reported outcomes, trended in favor of the candidate, they did not reach statistical significance.
In the past year, shares of Praxis have surged 272.6% compared with the industry’s 9.2% growth.
Image Source: Zacks Investment Research
Cross-study analyses strengthened the overall efficacy profile, showing robust improvements in mADL11 when ulixacaltamide-treated patients across both studies were compared with placebo. From a safety standpoint, ulixacaltamide was generally well tolerated, with a profile consistent with previous studies. Treatment-related adverse events were mostly mild in severity.
Other Factors Potentially Driving PRAX Stock Price Rally
Last week, Praxis reported the successful completion of its pre-new drug application (NDA) meeting with the FDA for ulixacaltamide to treat ET, with the agency aligning on the content of the impending NDA. The company received written feedback and held an in-person discussion, clearing a key regulatory step and reinforcing momentum from the successful phase III Essential3 program. Praxis now plans to submit its NDA in early 2026, positioning ulixacaltamide as a potential new treatment option in a market with limited effective therapies. Subject to its acceptance, the ulixacaltamide NDA could become PRAX’s first regulatory application under FDA review. This has also likely contributed to the stock price rally in the past three months.
Another catalyst likely underpinning the stock price surge is Praxis’ encouraging progress with relutrigine, another late-stage central nervous system asset. The company recently reported positive results from the registrational cohort of the EMBOLD study in patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEE), with positive data from an interim analysis triggering an early stop for efficacy. The data marks a meaningful milestone in a high-unmet-need, no-approved-therapy setting.
Importantly, the FDA has confirmed an upcoming meeting to review the results and discuss the regulatory path forward, adding near-term clarity on next steps. Praxis refrained from commenting on the timeline for filing an NDA for relutrigine to treat the DEE indication until then. PRAX previously reached an agreement with the FDA that positive EMBOLD study results could serve as substantial evidence of effectiveness for a potential NDA.
Beyond this, relutrigine’s opportunity extends into a broader DEE population through the ongoing registrational EMERALD study, which is expected to be completed in the second half of 2026 and could support a supplemental NDA by 2027 if successful.
Praxis Precision Medicines, Inc. Price and Consensus
Praxis Precision Medicines, Inc. price-consensus-chart | Praxis Precision Medicines, Inc. Quote
PRAX’s Zacks Rank and Stocks to Consider
Praxis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector include CorMedix (CRMD - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CRMD and ANIP sport a Zacks Rank #1 (Strong Buy) each, ARQT carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has gained 13% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.28 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.78 to $8.15. In the past year, shares of ANIP have rallied 40.9%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. In the past year, shares of ARQT have surged 148%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.