DeSimone Jill sold $3.6M of PRAX

Praxis Precision Medicines (PRAX) reported Q2 2026 results on an earnings call. Cash and marketable securities rose to $1.4B at June 30, 2026. Q2 net loss was $83.7M, with $78M operating cash burn. Ulixacaltamide PDUFA is Jan. 29, 2027, relutrigine PDUFA Dec. 27, 2026. The POWER1 vormatrigine trial missed its primary endpoint.

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. 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 to request an advisory committee meeting; PDUFA

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’ 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.