Praxis Precision Medicines, Inc.
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See all $PRAX insider activity →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.
Recent PRAX coverage spans earnings, market movers and financial news.
The call provides fresh, decision-relevant timelines and cash runway details that can shift probability-weighted valuation for two late-stage neurology assets.
Near-term FDA PDUFA milestones for two reviewed CNS assets can drive volatility and position re-pricing into late-2026/early-2027.
Clean FDA mid-cycle reviews for two late-stage programs, plus no Form FDA 483 findings and a strong cash balance, likely supports near-term upside momentum.
Near-term catalyst is FDA review progress for ulixacaltamide and relutrigine, plus cash runway and launch-prep momentum.
The Remagine platform deal expands Praxis's delivery approach for ulixacaltamide and could improve development optionality, but it is not yet a clinical or regulatory milestone.
alphai scores every news story that mentions PRAX with an AI model for sentiment and relevance, and aggregates insider trades from Praxis Precision Medicines, Inc.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
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.
9 min readPraxis 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.
5 min readPraxis 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.
4 min readPraxis 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
6 min readPraxis 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.
4 min readPraxis 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.
4 min readDeSimone 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.
2 min readPraxis 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.
3 min readPraxis 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 $
4 min readPraxis 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):
2 min read
