Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Relutrigine for the Treatment of Seizures Associated with SCN2A and SCN8A Developmental and Epileptic Encephalo...
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: GlobeNewswire
The Breakthrough Therapy Designation (BTD) was granted based on the highly compelling results from the Phase 2 EMBOLD trial in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) The EMBOLD cohort 2 pivotal trial is on track for topline results in H1 2026 with NDA filing to follow Praxis has recently initiated the EMERALD study investigating relutrigine broadly in DEEs BOSTON, July 17, 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 that the U.S. Food and Drug Administration (FDA) has granted BTD for relutrigine, a sodium channel functional state modulator for pediatric use for the treatment of patients with SCN2A and SCN8A DEEs. “This BTD represents a significant milestone for our relutrigine program and further vali
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News
- Has Praxis Precision Medicines Rally Gone Too Far or Is the Market Still Missing Something [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines (NASDAQ:PRAX) was given a new $750.00 price target on by analysts at UBS Group AG.MarketBeat
- Praxis Precision Medicines (NASDAQ:PRAX) had its "outperform" rating reaffirmed by analysts at Oppenheimer Holdings, Inc..MarketBeat
- 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
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