Praxis Precision Medicines (PRAX) Enters Into Licensing and Research Collaboration With Remagine Labs

Praxis Precision Medicines (PRAX) says it is entering a key period with four late-stage assets and FDA Breakthrough Therapy Designations. Two candidates are under FDA review: Relutrigine (priority review, decision Dec 27, 2026) and Ulixacaltamide (decision Jan 29, 2027). Relutrigine peak DEE revenues are projected over $5B, Ulixacaltamide over $10B. Vormatrigine Phase 2/3 POWER1 missed a primary endpoint; POWER2 enrollment was paused and plans to restart are underway.

Praxis Precision Medicines (PRAX) shares rose 9.3% pre-open after the company reported Q2 2026 results and said the FDA completed mid-cycle reviews for ulixacaltamide (PDUFA Jan 29, 2027) and relutrigine (PDUFA Dec 27, 2026) with no major safety or efficacy concerns and no advisory committee. FDA inspections had no Form 483 observations. Praxis reported about $1.4B cash and investments as of June 30, 2026 and received a third Breakthrough Therapy Designation for elsunersen.

Praxis Precision Medicines, Inc. (PRAX) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 praxisq22026pr.htm EX-99.1 Document Praxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2026 Financial Results Mid-cycle meeting completed for ulixacaltamide HCl; FDA identified no major safety or efficacy concerns to date and does not plan t

Praxis Precision Medicines’ shares rose after the FDA granted Breakthrough Therapy Designation to Elsunersen for seizures linked to SCN2A Developmental and Epileptic Encephalopathy (SCN2A-DEE), according to the company. Based on EMBRAVE Part A, Elsunersen cut monthly seizure frequency by 77% vs sham; results were sustained up to one year. Praxis is enrolling about 30 patients in EMBRAVE3.

Praxis Precision Medicine said the FDA granted Breakthrough Therapy Designation for elsunersen in SCN2A gain-of-function epilepsy (SCN2A-DEE), citing topline results from its randomized, sham-controlled Phase 1/2 EMBRAVE Part A trial in nine pediatric patients. The company reported seizure reductions maintained up to one year in an open-label extension and no drug-related serious adverse events up to 8 mg. EMBRAVE3 enrollment continues (~30 patients) after FDA discussions. Shares rose 4.70% to $

Praxis Precision Medicines (NASDAQ:PRAX) reported Phase 2/3 POWER1 study results on June 2, evaluating vormatrigine for focal onset seizures in a double-blind, placebo-controlled trial that allowed up to three approved anti-seizure drugs. The company said higher-dose groups showed positive effectiveness signals, while key seizure-reduction endpoints were not met. It reported a favorable safety profile and low discontinuation rates, and plans to assess results to guide POWER2 and further developm