Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026

EMBOLD data to serve as basis of efficacy and safety following discussion with the FDA EMBOLD data to serve as basis of efficacy and safety following discussion with the FDA

GlobeNewsWire • Dec 11, 2025

Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic Encephalopathy

Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen

GlobeNewsWire • Dec 9, 2025

PRAX Stock Skyrockets 520% in 3 Months: Here's What You Need to Know

Praxis stock soars after late-stage data show strong efficacy for ulixacaltamide therapy in essential tremor and momentum builds toward an early-2026 regulatory filing.

Zacks Investment Research • Dec 8, 2025

Praxis Surges 30%, Hitting Another 3-Year High, On A Surprise Win In Epilepsy

Praxis Precision Medicines shares shot skyward Friday after the company stopped an epilepsy study early due to strong effectiveness.

Investors Business Daily • Dec 5, 2025

Praxis' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next

Praxis Precision Medicines Inc. (NASDAQ: PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).

Benzinga • Dec 5, 2025

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

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

GlobeNewsWire • Dec 4, 2025

Praxis Precision Medicines Announces Positive Results from EMBOLD Study for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies

Successful interim analysis triggered early stop for efficacy Topline study results to be shared at the American Epilepsy Society Annual Meeting on December 6, 2025 Praxis confirms an upcoming meeting with the FDA to discuss the results and NDA path 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 positive results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs), following a recommendation by the Data Monitoring Committee to stop the study early for efficacy. “SCN2A and SCN8A DEEs are devastating conditions with extremely high mortality due to the debilitating seizure burden they impose on patients, and there are currently no approved treatment options.

GlobeNewsWire • Dec 4, 2025

Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BOSTON, Dec. 03, 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 that on December 1, 2025, the Compensation Committee of Praxis' Board of Directors granted restricted stock unit awards covering an aggregate of 3,594 shares of its common stock to six new non-executive employees under the Praxis Precision Medicines, Inc. 2024 Inducement Plan (the 2024 Inducement Plan). The restricted stock unit awards were granted as inducements material to the employees' entering into employment with Praxis in accordance with Nasdaq Listing Rule 5635(c)(4).

GlobeNewsWire • Dec 3, 2025

Praxis: Moving To Strong Buy Based On Ulixacaltamide Success In Treating ET

Praxis Precision Medicines, Inc. is upgraded to a Strong Buy, driven by pipeline progress and positive phase 3 data for Ulixacaltamide in Essential Tremor. PRAX's Ulixacaltamide achieved primary endpoints in two phase 3 studies, positioning it as the first potential FDA-approved therapy for Essential Tremor, targeting a large unmet market. Upcoming PRAX catalysts include a pre-NDA meeting with the FDA in Q4 2025 and a potential NDA filing for Ulixacaltamide in 2026, alongside advancing late-stage trials for Vormatrigine and Relutrigine.

Seeking Alpha • Nov 26, 2025

Praxis Precision Medicines, Inc. (PRAX) Discusses Essential3 Program and Statistical Modeling Approaches in Clinical Studies Transcript

Praxis Precision Medicines, Inc. ( PRAX ) Discusses Essential3 Program and Statistical Modeling Approaches in Clinical Studies November 24, 2025 1:00 PM EST Company Participants Marcio Souza - President, CEO & Director Conference Call Participants Douglas Tsao - H.C. Wainwright & Co, LLC, Research Division Chuck McCullogh Presentation Douglas Tsao H.C.

Seeking Alpha • Nov 25, 2025