Praxis Precision Medicines

PRAX

Market cap $9.54B

Praxis, a top biotech stock, surged Tuesday after the FDA assigned a potential approval date for its essential tremor treatment.

FDA assigned PDUFA target action date of January 29, 2027 No advisory committee meeting expected BOSTON, April 14, 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 accepted for review its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027 and is not planning to hold an advisory committee meeting.

Praxis Precision Medicines, Inc. remains a Strong Buy, driven by two NDA submissions and pipeline expansion opportunities targeting essential tremor and developmental and epileptic encephalopathies. The company's relutrigine achieved a 46% placebo-adjusted reduction in motor seizure frequency for SCN2A/SCN8A DEE and is under FDA priority review with a PDUFA date of September 27, 2026. Pipeline expansion includes relutrigine's potential sNDA for broad DEE and elsunersen for early-onset SCN2A DEE, with key data readouts expected in 2026–2027.

Praxis said elsunersen demonstrated a placebo-adjusted seizure reduction from baseline of 77% (p=0.015) in pediatric patients with SCN2A developmental and epileptic encephalopathy.

Elsunersen demonstrated placebo-adjusted seizure reduction from baseline of 77% (p=0.015) 71% of elsunersen-treated patients achieved >50% seizure reduction by period 6, with sustained benefit observed in the open-label extension for up to one year 100% of elsunersen patients - and none on placebo - had additional improvements, including sleep, motor function, muscle tone and attention No treatment-emergent or serious adverse events related to study drug reported BOSTON, April 06, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced positive topline results from the EMBRAVE Part A trial of elsunersen in pediatric patients with early-seizure onset SCN2A developmental and epileptic encephalopathy (DEE).  “We are thrilled to see the remarkable, consistent results from EMBRAVE Part A, showing 77% reduction in monthly seizures and disease modifying improvements in children with SCN2A early-seizure onset DEE.

BOSTON, April 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 April 1, 2026, the Compensation Committee of Praxis' Board of Directors granted restricted stock unit awards covering an aggregate of 3,558 shares of its common stock to eighteen 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).

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. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for relutrigine, for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of September 27, 2026.

5AM Venture Management sold 170,000 shares of Praxis Precision Medicines in the fourth quarter. The quarter-end position value decreased by $9.01 million as a result of the move, which marked a full exit from Praxis.

Cormorant Asset Management sold 50,000 shares of PRAX in the fourth quarter; the estimated trade size was $9.31 million based on quarterly average pricing. Meanwhile, the quarter-end value of the PRAX position increased by $227.00 million, reflecting both trading and stock price appreciation.

Deerfield Management Company increased its PRAX stake by 62,500 shares in the fourth quarter; the estimated transaction value was $11.64 million based on quarterly average prices. Meanwhile, the quarter-end value of the PRAX position rose by $221.69 million, reflecting both the share addition and price appreciation during the period.