Praxis Precision Medicines Announces Positive Pre-NDA Meeting with FDA for Ulixacaltamide in Essential Tremor

Rhea-AI Summary

Praxis Precision Medicines (NASDAQ: PRAX) completed a pre-NDA meeting with the FDA for ulixacaltamide in essential tremor and received written feedback plus an in-person discussion. The company said it gained alignment with the agency on NDA content and expects to submit the NDA in early 2026. Praxis highlighted momentum from the positive Essential3 program, where ulixacaltamide showed statistically significant, clinically meaningful improvements in daily functioning. Management framed the FDA feedback as advancing the program toward a potential new treatment for millions living with essential tremor.

Positive

• FDA alignment on NDA content after pre-NDA meeting
• Company expects NDA submission in early 2026
• Ulixacaltamide showed statistically significant functional improvements in Essential3

Negative

• NDA not yet submitted; regulatory approval still required
• Clinical-stage program means no marketed product or revenue yet

News Market Reaction

+3.05% 1.6x vol

51 alerts

+3.05% News Effect

+49.8% Peak in 5 hr 50 min

+$205M Valuation Impact

$6.93B Market Cap

1.6x Rel. Volume

On the day this news was published, PRAX gained 3.05%, reflecting a moderate positive market reaction. Argus tracked a peak move of +49.8% during that session. Our momentum scanner triggered 51 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $205M to the company's valuation, bringing the market cap to $6.93B at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

NDA submission timing: 2026

1 metrics

NDA submission timing 2026 Company expects to complete ulixacaltamide NDA submission in early 2026

Market Reality Check

Price: $319.54 Vol: Volume 684,650 is below t...

low vol

$319.54 Last Close

Volume Volume 684,650 is below the 20-day average of 938,853 (relative volume 0.73x). low

Technical Price 186.15 is trading above the 200-day MA at 67.96, reflecting a strong pre-news uptrend.

Historical Context

5 past events · Latest: Dec 03 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Inducement grants	Neutral	+3.9%	Inducement RSU awards to new employees under 2024 Inducement Plan.
Nov 24	Scientific meeting	Positive	-3.5%	Upcoming AES presentations on preclinical and clinical epilepsy portfolio data.
Nov 20	Fireside chat	Positive	-13.3%	Analyst-hosted fireside chat on ulixacaltamide clinical data interpretation.
Nov 06	Inducement grants	Neutral	+4.7%	RSU awards to new employees under Nasdaq Listing Rule 5635(c)(4).
Nov 05	Investor conferences	Positive	-4.1%	Participation in multiple November investor conferences and webcasts.

Pattern Detected

Recent news has often seen mixed reactions: several seemingly positive pipeline or visibility updates were followed by negative moves, while routine inducement grant notices saw modest gains.

Recent Company History

Over the last month, Praxis issued multiple updates highlighting corporate activity and clinical communication. Investor and scientific outreach included epilepsy data presentations at AES and a fireside chat focused on ulixacaltamide, yet those events coincided with declines of -3.46% and -13.33%. In contrast, routine inducement grant announcements on Nov 6, 2025 and Dec 1, 2025 were followed by gains of 4.68% and 3.93%. Today’s positive pre‑NDA FDA alignment for ulixacaltamide fits the broader narrative of advancing late‑stage programs after the Essential3 results.

Regulatory & Risk Context

Short Interest: 9.45%

Short Interest

9.45%

0% 15% 30%+

moderate

Short interest at 9.45% of float with 7.03 days to cover indicates moderate positioning that could amplify moves in either direction if sentiment shifts.

Market Pulse Summary

This announcement highlights successful pre-NDA interactions with the FDA and plans to submit an uli...

Analysis

This announcement highlights successful pre-NDA interactions with the FDA and plans to submit an ulixacaltamide NDA in early 2026 for essential tremor, building on prior Essential3 efficacy data. In recent months, Praxis has raised substantial capital, advanced multiple CNS programs, and increased scientific and investor outreach. Investors may focus on the eventual NDA content, regulatory review outcomes, cash usage trends, and any further clinical or safety updates related to ulixacaltamide and the broader pipeline.

Key Terms

pre-NDA, New Drug Application, essential tremor, clinically meaningful, +4 more

8 terms

pre-NDA regulatory

"announced the successful completion of its pre-NDA (New Drug Application) meeting"

A "pre-nda" is an early-stage agreement where parties share confidential information before fully committing to a deal or partnership. It acts like a promise to keep shared details private, allowing them to explore opportunities safely. For investors, it signals serious interest and helps ensure that sensitive information remains protected as discussions progress.

New Drug Application regulatory

"completion of its pre-NDA (New Drug Application) meeting with the FDA"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

essential tremor medical

"ulixacaltamide in essential tremor who currently lack effective and safe treatment options"

Essential tremor is a neurological condition that causes involuntary shaking, usually in the hands or arms, which can make everyday tasks difficult. While it is not life-threatening, it can impact a person's ability to perform precise movements. For investors, understanding such health conditions is important because they can influence a person's productivity, decision-making, and overall financial stability.

clinically meaningful medical

"demonstrated statistically significant and clinically meaningful improvements in daily functioning"

"Clinically meaningful" describes a change or result that is significant enough to have a real impact on a person's health or well-being. For investors, it matters because it indicates whether a new treatment or discovery offers a genuine benefit, rather than just a small or temporary improvement that may not make a real difference in outcomes. In essence, it highlights whether something is truly valuable or just minor noise.

statistically significant medical

"ulixacaltamide demonstrated statistically significant and clinically meaningful improvements"

"Statistically significant" means that a result or difference observed in data is unlikely to have occurred by chance alone, suggesting there is a real underlying effect. For investors, it indicates that the findings or patterns they see are likely meaningful and not just random noise, helping them make more informed decisions based on reliable information. Think of it as a pattern that is strong enough to stand out clearly from background randomness.

central nervous system (CNS) medical

"therapies for central nervous system (CNS) disorders characterized by neuronal"

The central nervous system (CNS) is the part of the body that includes the brain and spinal cord, acting as the control center for processing information and directing actions. It is essential for coordinating all bodily functions, from movement to thinking. For investors, understanding the CNS is important because it illustrates how complex systems—like markets or organizations—rely on core components to operate smoothly.

neuronal excitation-inhibition imbalance medical

"CNS disorders characterized by neuronal excitation-inhibition imbalance"

Neuronal excitation-inhibition imbalance occurs when the brain's cells that send signals become too active or not active enough, disrupting normal communication. Imagine a busy city where traffic lights are out of sync, causing traffic jams or empty roads—similar disruptions can affect brain function. For investors, such imbalances can be linked to mental health issues that may influence decision-making, focus, and overall well-being.

NDA regulatory

"alignment from the agency on the content of the NDA and expects to complete"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

AI-generated analysis. Not financial advice.

Praxis confirms plans to submit the essential tremor NDA for ulixacaltamide in early 2026

BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of its pre-NDA (New Drug Application) meeting with the FDA, including receipt of written feedback and an in-person meeting. Praxis has gained alignment from the agency on the content of the NDA and expects to complete its NDA submission in early 2026.

“We are very pleased with the collaborative discussions we recently had with the FDA and remain on track to submit Praxis’ first NDA in early 2026. Building on the strong momentum from the positive Essential3 program, where ulixacaltamide demonstrated statistically significant and clinically meaningful improvements in daily functioning, the FDA feedback moves us closer to delivering a much-needed therapy to the millions of people living with essential tremor who currently lack effective and safe treatment options,” said Marcio Souza, president and chief executive officer.

About Essential Tremor (ET)

Essential tremor is the most common movement disorder, affecting roughly seven million people in the United States alone, representing a multi-billion-dollar commercial opportunity. ET is characterized by involuntary rhythmic movement in the upper limbs, with or without tremor in other body locations such as the head, vocal cords, or legs. These tremors significantly disrupt daily living and are progressive in nature, with increases in tremor severity and amplitude commonly observed over the course of the disease. Propranolol, a beta-blocker, is the only approved pharmacotherapy for ET, offering limited efficacy and poor tolerability and is also contraindicated for comorbidities that affect a significant share of the ET population. Other beta blockers and anti-convulsants are used off-label, though similarly are characterized by limited efficacy and tolerability. The vast majority of patients are left without a treatment option, with an estimated minimum of 2 million patients seeking treatment. In a patient survey, up to 77% of patients felt their ET is inadequately controlled and up to 50% of patients are not receiving treatment. Similarly, U.S. neurologists surveyed indicated that 85% of their visits are for patients seeking treatment, and 40% of their patients are not receiving any treatment. These findings underscore the need for more effective treatments for ET.

About Ulixacaltamide

Ulixacaltamide is a differentiated and highly selective small molecule inhibitor of T-type calcium channels designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity. Ulixacaltamide is the most advanced program within Praxis’ Cerebrum™ small molecule platform.

About Praxis  
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on Facebook, Instagram, LinkedIn and Twitter/X.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Praxis’ future expectations, plans and prospects, including, without limitation, statements regarding the development of Praxis’ product candidates and the anticipated timing of regulatory submissions and interactions, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “endeavor,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would” and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995.

The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials; the expected timing of clinical trials, data readouts and the results thereof, and submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials; and other risks concerning Praxis’ programs and operations as described in its Annual Report on Form 10-K for the year ended December 31, 2024 and as updated in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other filings made with the Securities and Exchange Commission. Although Praxis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on information and factors currently known by Praxis. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Investor Contact: 
Praxis Precision Medicines 
investors@praxismedicines.com 
857-702-9452 
 
Media Contact:
Dan Ferry
Life Science Advisors
Daniel@lifesciadvisors.com
617-430-7576

FAQ

What did Praxis announce about ulixacaltamide and the FDA on December 4, 2025?

Praxis announced completion of a pre-NDA meeting with the FDA, receipt of written feedback, and alignment on NDA content for ulixacaltamide.

When does Praxis expect to submit the ulixacaltamide NDA (PRAX)?

Praxis expects to complete and submit the ulixacaltamide NDA in early 2026.

What clinical evidence did Praxis cite for ulixacaltamide in essential tremor (PRAX)?

Praxis referenced the positive Essential3 program, reporting statistically significant, clinically meaningful improvements in daily functioning.

Does the FDA meeting mean ulixacaltamide is approved for essential tremor (PRAX)?

No; the company received pre-NDA alignment and feedback but regulatory approval is still required after submission and review.

How might the pre-NDA meeting affect PRAX investors and timeline?

The meeting indicates regulatory alignment and supports the company’s plan to submit an NDA in early 2026, but approval timing and outcome remain uncertain.