Recent 8-K filings for PRAX
Highest-materiality recent filing
Praxis Precision Medicines announces positive topline results from EMBOLD study of relutrigine in SCN2A/SCN8A DEE
- Placebo-adjusted reduction of 46% in countable motor seizures for relutrigine-treated patients.
- 5 of 16 randomized patients achieved 28-day seizure-free status on relutrigine vs. none on placebo.
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Praxis Precision Medicines: Phase 2/3 vormatrigine study fails primary endpoint in focal seizures
POWER1 study of vormatrigine in focal onset seizures did not meet primary success measure.
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Praxis reports Q1 net loss of $92.6M; FDA accepts NDAs for ulixacaltamide and relutrigine
FDA accepted NDA for ulixacaltamide (Essential Tremor) with PDUFA Jan 29, 2027; relutrigine NDA (SCN2A/SCN8A DEEs) granted priority review with PDUFA Sept 27, 2026.
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Praxis Precision: FDA accepts NDA for ulixacaltamide in essential tremor; PDUFA Jan 29, 2027
FDA accepted NDA for ulixacaltamide HCl to treat essential tremor in adults; PDUFA target action date January 29, 2027.
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Elsunersen achieved 77% placebo-adjusted seizure reduction (p=0.015) in 9-patient Phase 1/2 trial.
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Praxis reports Q4 net loss $88.9M; submits two NDAs; cash $926M
Net loss $88.9M in Q4 2025 ($303.3M FY), vs $58.7M ($182.8M FY) prior year.
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Praxis Precision Medicines prices $661M equity offering at $260/share, net proceeds ~$621M
Offering of 2,212,000 shares plus full exercise of underwriter option for 331,800 shares at $260/share.
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PRAX gets FDA Breakthrough Therapy Designation for ulixacaltamide in essential tremor
Ulixacaltamide granted BTD for treatment of essential tremor based on Essential3 Phase 3 data.
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Praxis gets FDA nod to simplify EMBRAVE3 study; relutrigine NDA on track for early 2026
FDA agreed to convert EMBRAVE3 from double-blind to single-arm baseline-controlled study, enrolling 30 patients (down from 40).
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Praxis gains FDA alignment for ulixacaltamide NDA; relutrigine & vormatrigine trials positive
Ulixacaltamide pre-NDA meeting with FDA completed; NDA submission expected early 2026.
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Praxis reports Q3 net loss $73.9M; ulixacaltamide Phase 3 positive; pro forma cash ~$956M
Ulixacaltamide met primary endpoints in both Essential3 Phase 3 studies for essential tremor; pre-NDA meeting with FDA scheduled Q4 2025.
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FDA grants Type B meeting for Praxis's ulixacaltamide in Q4 2025
FDA granted a Type B meeting following review of Essential3 topline results for ulixacaltamide.
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Offering of 3,025,480 shares at $157.00 and 318,470 pre-funded warrants at $156.9999 per underlying share.
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Study 1: 4.3 pt mean improvement in mADL11 at Week 8 vs 1.7 pt placebo (p<0.0001); all key secondary endpoints significant.
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Praxis terminates $250M Jefferies ATM, enters new $250M ATM with TD Cowen
Terminated 2024 Sales Agreement with Jefferies effective Sept 2, 2025; no penalties.
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Praxis reports RADIANT study positive: 56.3% median seizure reduction; Q2 net loss $71.1M
Vormatrigine in focal onset seizures (n=37): 56.3% median reduction in seizure frequency over 8 weeks; 22% achieved 100% reduction in last 28 days.
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FDA grants Breakthrough Therapy Designation for relutrigine in SCN2A/SCN8A DEEs
FDA granted Breakthrough Therapy Designation for relutrigine in pediatric SCN2A and SCN8A DEEs.
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Praxis posts Q1 net loss of $69.3M; cash $472M, runway into 2028
Net loss $69.3M for Q1 2025 vs $39.6M YoY; R&D spend $60.8M (up 125% YoY).
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Updated EMBOLD open-label data (n=12) show sustained seizure reduction and increased seizure-free periods through 11 months of relutrigine treatment in SCN2A/SCN8A DEEs.
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Praxis Essential3 interim analysis recommends futility; studies continue to Q3 2025
IDMC recommended stopping Essential3 Study 1 for futility; Praxis continues both studies to completion.
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Praxis reports $470M cash, NDA plans for ulixacaltamide in 2025, and UCB option exercise for KCNT1
Cash, cash equivalents and marketable securities ~$470M at Dec 31, 2024; runway into 2028.
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Praxis Q3 net loss $51.9M; relutrigine seizure freedom; ulixacaltamide interim Q1 2025
Cash and equivalents $411.2M at Sep 30, 2024, up from $81.3M at Dec 31, 2023; net loss $51.9M vs $24.6M prior year Q3.
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Praxis Precision amends exec severance; CEO multiplier 1.75x, CFO/GC 1x
CEO Marcio Souza gets 1.75x base salary plus target bonus, plus prorated bonus, on change-in-control qualifying termination.
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Placebo-adjusted reduction of 46% in countable motor seizures for relutrigine-treated patients.
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Praxis reports Q2 2024 net loss $32.7M; cash $433.8M; multiple trial milestones on track
Cash and investments $433.8M ($81.3M at Dec 31, 2023); runway into 2027.
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Praxis Q1 net loss $39.6M; cash $451.2M, positive PRAX-628 data; Essential3 topline H2 2024
Net loss $39.6M in Q1 2024 vs $37.5M a year ago; R&D expense $27.0M, G&A $15.3M.
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Praxis Precision Medicines prices $56.50/share offering, expected $215.6M net proceeds
Offering includes 3,318,585 shares at $56.50 and 221,238 pre-funded warrants at $56.4999; underwriters exercised option for 530,973 additional shares.
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15 mg cohort: 100% total response (20% partial, 80% complete); 45 mg cohort: 100% complete response.
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Cash and equivalents $247.6M as of Feb 29, 2024, funded by $161.7M January 2024 follow-on; runway into 2026.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.75 · Most common event other_material