globenewswire.com · 29 jun

Praxis Precision Medicines Announces Extension Period for Relutrigine for Treatment of SCN2A and SCN8A Developmental and Epileptic Encephalopathies

FDA sets updated PDUFA date of December 27, 2026 BOSTON, June 29, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) notified Praxis that it has extended by three months the review period for its New Drug Application (NDA) for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs), setting an updated PDUFA target action date from September 27, 2026 to December 27, 2026. The extension follows Praxis's submission of additional sensitivity analyses of existing clinical data, which the FDA has deemed a "major amendment," allowing additional time for the FDA to review.

benzinga.com · 22 jun

Praxis' Seizure Drug Move Towards Faster Development After Positive Trial Results

Praxis Precision Medicines Inc. (NASDAQ:PRAX) said on Monday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to elsunersen (PRAX-222), its investigational therapy for seizures associated with SCN2A developmental and epileptic encephalopathy (SCN2A-DEE) caused by gain-of-function variants in the SCN2A gene.

globenewswire.com · 22 jun

Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic Encephalopathy Caused by Gain of Function Variants

The Breakthrough Therapy Designation (BTD) was granted based on the positive results from the EMBRAVE Part A trial of elsunersen Elsunersen demonstrated a 77% sham-adjusted reduction in monthly seizures (p=0.015), with benefit sustained in the open-label extension for up to one year The pivotal EMBRAVE3 study is enrolling under a streamlined, single-arm registrational pathway aligned with the FDA Elsunersen now holds Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease Designations from the FDA, and Orphan Drug and PRIME designations from the EMA BOSTON, June 22, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted BTD for elsunersen (PRAX-222), an antisense oligonucleotide (ASO) for the treatment of seizures associated with SCN2A Developmental and Epileptic Encephalopathy (SCN2A-DEE) caused by Gain of Function (GoF) variants in SCN2A. “Our third Breakthrough Therapy Designation for the late-stage pipeline is a defining milestone for Praxis, with immediate implications for the elsunersen program and for our Solidus™ ASO platform.

seekingalpha.com · 8 jun

Praxis Precision Medicines, Inc. (PRAX) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

Praxis Precision Medicines, Inc. (PRAX) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

seekingalpha.com · 5 jun

Praxis' Premium Price May Reflect Unrealistic Market Prospects In Essential Tremor

Praxis Precision Medicines, Inc. is valued as a pure-play on ulixacaltamide's commercial launch in essential tremor, with pipeline optionality limited. I maintain a cautious Hold rating, as PRAX trades above my fair value estimate of $223.73 versus a current share price of $265. Key risks include real-world persistence, payer step edits, and competition from cheap off-label generics, which could materially limit ulixacaltamide's addressable market and duration.

globenewswire.com · 4 jun

Praxis Precision Medicines to Participate in Goldmans Sachs 47th Annual Global Healthcare Conference

BOSTON, June 04, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced it will be presenting a corporate overview at the Goldman Sachs 47th Annual Global Healthcare Conference 2026 taking place in Miami, FL at the Loews Miami Beach Hotel on Monday, June 8, 2026 at 8:00am ET.

globenewswire.com · 2 jun

Praxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BOSTON, June 02, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (Nasdaq: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that on June 1, 2026, the Compensation Committee of Praxis' Board of Directors granted restricted stock unit awards covering an aggregate of 2,754 shares of its common stock to thirteen new non-executive employees under the Praxis Precision Medicines, Inc. 2024 Inducement Plan (the 2024 Inducement Plan). The restricted stock unit awards were granted as inducements material to the employees' entering into employment with Praxis in accordance with Nasdaq Listing Rule 5635(c)(4).

benzinga.com · 2 jun

Praxis Reassesses Vormatrigine Program After Pivotal Epilepsy Study Misses Primary Endpoint

Praxis Precision Medicines Inc. (NASDAQ:PRAX) on Monday reported results from its Phase 2/3 POWER1 study of vormatrigine for focal onset seizures.