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- **Breakthrough Efficacy**: Vormatrigine achieved 56% median seizure reduction and 22% seizure-free rate in RADIANT, outperforming cenobamate even in high-dose patients.
- **Fast-Acting & Tolerable**: 54% of patients responded by week 1, with only 20% adverse event rate vs. competitors.
- **Strategic Pipeline**: POWER2 (40mg dose added) and POWER3 (monotherapy) studies to expand label, targeting $2-3B hyperrefractory epilepsy market.
- **Mood Benefits**: Observed mood improvements may support broader CNS applications, with formal endpoints added to future trials.

**【CEO Opening Remarks】**
- Announced best-in-disease results for vormatrigine in the RADIANT study, highlighting 56% median seizure reduction and 22% seizure-free rate.
- Emphasized vormatrigine's unique profile: once-daily dosing, fast-acting, no food effect, and no significant drug-drug interactions.
- Discussed the company's robust pipeline with 4 late-stage assets and 5 clinical readouts expected within the next year.
- Highlighted strong recruitment capabilities, with 99 patients screened for the POWER1 study as of July 25, 2025.

**【CSO (Steve Petrou) Study Details】**
- RADIANT study design: 28-day baseline observation followed by 8 weeks of 30mg vormatrigine.
- Key results:
  - 56% median seizure reduction (vs. 30% on cenobamate).
  - 60% responder rate (≥50% reduction), with 22% seizure-free.
  - Rapid onset: 54% response by week 1, 67% by week 8.
- Safety: 23% discontinuation rate, primarily due to background ASM adjustments.
- Notable: 30% of patients were on high-dose cenobamate (≥300mg), yet still achieved 55% response.

**【CEO Future Pipeline Update】**
- POWER2 study (400 patients, 12 weeks) to test 20mg, 30mg, and 40mg doses, with enrollment expected to complete in 2026.
- Added 40mg dose arm based on RADIANT modeling for potential higher efficacy.
- POWER3 study (monotherapy) to initiate in early 2026, targeting refractory epilepsy patients transitioning off background ASMs.
- Highlighted mood improvement observations in RADIANT, leading to inclusion of depression/mood endpoints in POWER2.

**【Q&A Highlights】**
- **Efficacy Across Background Therapies**: Consistent response rates (55-57%) across sodium channel blockers, SV2A modulators, and cenobamate.
- **Discontinuation Rate Insights**: 6 patients with proactive background ASM reduction had no AEs or discontinuations.
- **POWER1 Enrollment**: 99 patients screened as of July 25, with final data expected by year-end 2025.
- **Safety Profile**: Vormatrigine AE rate (20%) significantly lower than competitors, with no meaningful drug-drug interactions.
- **Market Potential**: $2-3B addressable market for hyperrefractory epilepsy, with vormatrigine uniquely positioned for monotherapy.


Praxis Precision Medicines, Inc. (PRAX) Q2 2025 Earnings Call Transcript

Revenue

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PRAX

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