$PRAX

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 (NASDAQ:PRAX) and Remagine Labs announced a licensing and research collaboration to develop an iontophoretic transdermal patch delivering ulixacaltamide, using Remagine’s multi-day skin dosing platform. Separately, Praxis said the FDA extended a relutrigine NDA review by three months, moving the PDUFA date from Sept. 27 to Dec. 27.

Praxis Precision Medicines (NASDAQ: PRAX) and Remagine Labs announced a research and license collaboration to develop an iontophoretic transdermal patch delivering ulixacaltamide for essential tremor. The FDA accepted Praxis’s NDA in April 2026 with a PDUFA target date of Jan. 29, 2027. Praxis will invest in Remagine’s equity to accelerate the program.

DeSimone Jill sold 11,600 shares of Praxis Precision Medicines, Inc. (PRAX) at an average of $311.32 ($301.44–$315.70, $3.61M total) across 12 trades on 2026-06-24 under a Rule 10b5-1 trading plan.

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, Inc. (PRAX) filed an SEC Form 8-K — Submission of Matters to a Vote of Security Holders. prax-20260610 FALSE 0001689548 0001689548 2026-06-10 2026-06-10 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported):

BTIG reaffirmed a Buy rating on Praxis Precision Medicines (PRAX) and cut its price target to $810 from $843 on June 2. The firm cited Phase 2/3 POWER1 results for vormatrigine, noting revenue loss but pointing to continued patient retention in an open-label extension and response/seizure trends. Truist also maintained a Buy rating, raising its target to $715.