BioPharmSignal logoBioPharmSignal

Biotech News

Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs

Praxis Precision Medicines (PRAX)Praxis Precision MedicinesFDA / regulatory

FDA assigned PDUFA target action date of September 27, 2026 BOSTON, March 30, 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.

Open original release

Related news

PRAXPraxis Precision Medicines2026-04-14 11:30 EST

Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor

PRAXPraxis Precision Medicines2026-04-06 12:00 EST

Praxis Precision Medicines Announces Positive Results from the EMBRAVE Part A Trial of Elsunersen in Patients with SCN2A Early-Onset Developmental and Epileptic Encephalopathy

AXSMAxsome2026-07-15 11:00 EST

Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy

BTAIBioXcel2026-04-01 11:00 EST

BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting

TEVATeva Pharmaceutical Industries2026-03-30 12:00 EST

Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)

IKTInhibikase Therapeutics2026-07-23 12:00 EST

Inhibikase Therapeutics Announces FDA Orphan Drug Designation Granted to IKT-001 for the Treatment of PAH

AXSMAxsome2026-05-01 11:15 EST

Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought Leader

TEVATeva Pharmaceutical Industries2026-04-29 10:30 EST

Teva to Acquire Emalex Biosciences, Adding NDA-Ready, First-in-Class Therapy to Neuroscience Pipeline and Accelerating Teva’s Pivot to Growth Strategy

BCLIBrainstorm Cell Therapeutics Inc.2026-06-02 13:00 EST

BrainStorm Cell Therapeutics Announces Publication Calling for Updated FDA Approaches to ALS, Rare Diseases and Regenerative Medicine

KTTAPasithea Therapeutics2026-06-02 11:02 EST

Pasithea Therapeutics Announces Orphan Drug Designation by FDA of PAS-004 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

View all latest news

Praxis Precision Medicines

Praxis Precision Medicines is a neuroscience company focused on precision approaches to brain disease and movement disorders. Its platform aims to translate genetics and neurobiology into treatment options.

Recent company news

PRAXPraxis Precision Medicines2026-06-01 20:15 EST

Praxis Precision Medicines Provides Vormatrigine Program Update

PRAXPraxis Precision Medicines2026-05-07 12:00 EST

Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2026 Financial Results

PRAXPraxis Precision Medicines2026-05-05 20:01 EST

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

PRAXPraxis Precision Medicines2026-05-04 20:01 EST

Praxis Precision Medicines to Report First Quarter 2026 Financial Results on Thursday, May 7, 2026, and Participate in Upcoming Investor Conference

PRAXPraxis Precision Medicines2026-04-14 11:30 EST

Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor

Stock data

Close
315.80 USD
Market cap
7.19B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States