Highest-materiality recent filing
Praxis Q2 net loss $83.7M; FDA mid-cycle positive for ulixacaltamide and relutrigine; no AdCom
FDA mid-cycle meetings for ulixacaltamide (ET) and relutrigine (DEEs) found no major safety/efficacy concerns; no advisory committee planned; PDUFA dates Jan 29, 2027 and Dec 27, 2026.
FDA extends relutrigine PDUFA date by 3 months to Dec 27, 2026
FDA extended relutrigine NDA review by 3 months due to additional sensitivity analyses submitted by Praxis.
FDA grants Breakthrough Therapy Designation for Praxis Precision Medicines' elsunersen for SCN2A-DEE
FDA granted Breakthrough Therapy Designation for elsunersen (PRAX-222), an antisense oligonucleotide for seizures in SCN2A Developmental and Epileptic Encephalopathy.
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.
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.
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.
Elsunersen achieved 77% placebo-adjusted seizure reduction (p=0.015) in 9-patient Phase 1/2 trial.
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.
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.
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.
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).
Praxis gains FDA alignment for ulixacaltamide NDA; relutrigine & vormatrigine trials positive
Ulixacaltamide pre-NDA meeting with FDA completed; NDA submission expected early 2026.
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.
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.
Offering of 3,025,480 shares at $157.00 and 318,470 pre-funded warrants at $156.9999 per underlying share.
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.
Praxis terminates $250M Jefferies ATM, enters new $250M ATM with TD Cowen
Terminated 2024 Sales Agreement with Jefferies effective Sept 2, 2025; no penalties.
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.
FDA grants Breakthrough Therapy Designation for relutrigine in SCN2A/SCN8A DEEs
FDA granted Breakthrough Therapy Designation for relutrigine in pediatric SCN2A and SCN8A DEEs.
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).
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.
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.
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.
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.
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.
Placebo-adjusted reduction of 46% in countable motor seizures for relutrigine-treated patients.
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.
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.
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.
15 mg cohort: 100% total response (20% partial, 80% complete); 45 mg cohort: 100% complete response.
Cash and equivalents $247.6M as of Feb 29, 2024, funded by $161.7M January 2024 follow-on; runway into 2026.
Praxis raises ~$161.7M in stock/warrant offering; funds operations into 2026
Public offering of 3,168,275 shares of common at $35.50 and pre-funded warrants for 1,056,725 shares at $35.4999.
Entered exclusive collaboration with Tenacia Biotechnology for ulixacaltamide in essential tremor in Greater China.
Praxis Precision Medicines announces 1-for-15 reverse stock split effective Nov 28, 2023
Board approved final ratio of 1-for-15, within previously authorized range of 1-for-5 to 1-for-25.
Praxis Q3 net loss $24.6M; starts Essential3 Phase 3 for ulixacaltamide
Cash $101.1M as of Sep 30, 2023, providing runway into Q1 2025.
Praxis Precision updates clinical pipeline at R&D Day; ulixacaltamide NDA plan 2025
Ulixacaltamide: 55% vs 31% patients achieved ≥3-point mADL11 improvement (p=0.023) in Essential1.
Praxis posts Q2 net loss $34.3M, plans ulixacaltamide Phase 3 after FDA meeting
Q2 net loss $34.3M, cash $124.3M; cash runway into Q1 2025 from June offering net $63.4M.
Offering includes 55.15M shares of common stock and pre-funded warrants to purchase 7.05M shares at $0.95/$0.9499 per share.
On March 17, 2023, Nicole Sweeny, Chief Commercial Officer of Praxis Precision Medicines, Inc. (the “Company”), and the Company determined that, considering the current priorities of the Company, Ms. Sweeny would depart from the Company, effective March 31, 2023.
On August 10, 2022, Stefan Vitorovic, a member of the board of directors (the “Board”) of Praxis Precision Medicines, Inc. (the “Company”), notified the Board of his intention to resign from the Board, effective August 12, 2022.
On July 21, 2022, Bernard Ravina, Chief Medical Officer of Praxis Precision Medicines, Inc. (the “ Company ”), who is currently on leave attending to family medical matters, and the Company mutually decided that Dr. Ravina will transition from his full-time position as Chief Medical Officer to a part-time role as strategic advisor to the Company on August 1, 2022.
elected Jill DeSimone to the Board as a Class I director, effective May 23, 2022
Max materiality 0.90 · Median 0.70 · Most common event other_material