From GlobeNewswire: 2025-05-02 08:30:00

Praxis Precision Medicines plans six major study readouts in the next 12 months. Initiating pivotal studies in two DEE programs in mid-2025. Vormatrigine shows best-in-class safety profile with no food effect. Virtual investor event scheduled for May 2, 2025. $472 million in cash and investments as of March 31, 2025, ensuring funding into 2028.

Praxis Precision Medicines making strides in late-stage epilepsy portfolio. Expecting transformative year with multiple upcoming catalysts and data readouts. Vormatrigine demonstrates strong competitive differentiation. EMBOLD study on track for topline results by first half of 2026. Strong financial position supports funding for late-stage programs into 2028.

Vormatrigine targets hyperexcitable state of sodium-channels in common epilepsies. Phase 1 studies show strong competitive differentiation. Food effect study demonstrates no significant impact on absorption. ENERGY program enrollment progressing. RADIANT and POWER1 studies continue to attract epilepsy patients. POWER2 study set to initiate in second half of 2025.

Relutrigine evaluated in EMBOLD study for SCN2A and SCN8A DEEs. EMERALD study to initiate in mid-2025 for broader DEE patient population. Rare Pediatric Disease Designation in three indications. Ulixacaltamide Essential3 program for Essential Tremor continues despite interim analysis results. Topline results expected in third quarter of 2025.

Elsunersen targets early-seizure-onset SCN2A DEE. Two studies support registrational filing. The EMBRAVE Part A Phase 1/2 study is ongoing, with topline results expected in the first half of 2026. The EMBRAVE3 registrational study for SCN2A GoF-DEE will start in mid-2025. Praxis plans to nominate development candidates for ASO therapeutic initiatives in 2025. Financially, Praxis had $472.0 million in cash as of March 31, 2025, with no collaboration revenue recognized and a net loss of $69.3 million for the quarter.

Elsunersen, an antisense oligonucleotide, has shown promising results in treating early-onset SCN2A developmental and epileptic encephalopathy. Vormatrigine, a next-generation small molecule, targets sodium-channels in the brain for epilepsy treatment. Relutrigine, a first-in-class small molecule, is designed to treat DEE by inhibiting seizures. Ulixacaltamide is a T-type calcium channel inhibitor for essential tremor treatment. Elsunersen has received designations from the FDA and EMA for treating SCN2A-DEE. The program is ongoing with Ionis Pharmaceuticals, Inc., and RogCon, Inc. For more information on the EMBRAVE study, visit https://www.embravestudy.com/.

Praxis Precision Medicines is developing therapies for CNS disorders by translating insights from genetic epilepsies. The company has multiple clinical-stage product candidates for epilepsy and movement disorders. For more information, visit www.praxismedicines.com and follow them on social media.

Praxis Precision Medicines reported its financials for March 31, 2025. With cash and cash equivalents of $165,567 and marketable securities of $306,456, the total assets amounted to $478,736. Total liabilities and stockholders’ equity were also reported in detail. The company’s consolidated statements of operations showed a net loss of $69,296 for the quarter. 1. The stock market reached new highs today, with the S&P 500 closing at a record 3,000 points. This surge was driven by strong earnings reports from tech giants like Amazon and Facebook, as well as positive economic data indicating a robust economy.

2. In other news, the unemployment rate dropped to a 50-year low of 3.7%, with job growth exceeding expectations. The Labor Department reported that 224,000 new jobs were added in June, far surpassing the projected 160,000. This marks the longest streak of job creation on record.

3. On the international front, tensions are rising in the Persian Gulf as Iran seizes another foreign tanker. The UK has deployed a second warship to the region in response to this latest incident, heightening fears of a potential military conflict.

4. Meanwhile, climate change continues to be a pressing issue, with record-breaking temperatures reported across Europe. France recorded its highest temperature ever at 114.6 degrees Fahrenheit, prompting concerns about the increasing frequency and intensity of heatwaves due to global warming.



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