Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic Encephalopathy
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: GlobeNewswire
Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm, baseline-controlled study Enrollment in EMBRAVE3 is quickly accelerating and topline results expected in 2026 Topline results from ongoing EMBRAVE study (Part A, n=9) expected in 1H 2026 BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) and agreement to immediately convert the EMBRAVE3 registrational study of elsunersen in early-onset SCN2A developmental and epileptic encephalopathy (DEE) into a single-arm study where all patients will r
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News
- Praxis Precision Medicines (NASDAQ:PRAX) was given a new $313.00 price target on by analysts at Deutsche Bank Aktiengesellschaft.MarketBeat
- Praxis Precision to file an NDA for relutrigine in encephalopathies in 2026 [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026 [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026GlobeNewswire
- Praxis Precision Medicines (NASDAQ:PRAX) had its "buy" rating reaffirmed by analysts at Jefferies Financial Group Inc..MarketBeat
PRAX
Earnings
- 11/5/25 - Beat
PRAX
Sec Filings
- 12/11/25 - Form 8-K
- 12/8/25 - Form 8-K
- 11/21/25 - Form 4
- PRAX's page on the SEC website