PRAX

Collaboration aims to quickly enable ulixacaltamide to be delivered via active transdermal route         Potential to expand the addressable market for ulixacaltamide beyond the initial patient population and to enable additional life-cycle management opportunities         Praxis to make equity investment in Remagine Labs, accelerating the companies' collaboration BOSTON, Mass. and AUSTIN, Texas, July 07, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a fully integrated central nervous system (CNS) precision neuroscience biopharmaceutical company, and Remagine Labs, Inc., a developer of electronically controlled transdermal drug delivery systems, today announced a research collaboration and license agreement to develop an iontophoretic transdermal patch for the delivery of ulixacaltamide, Praxis's highly selective T-type calcium channel inhibitor in development for essential tremor (ET).

BOSTON, July 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 July 1, 2026, the Compensation Committee of Praxis' Board of Directors granted restricted stock unit awards covering an aggregate of 951 shares of its common stock to five 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 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.

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.

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

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.

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.

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).

POWER1 Study in highly refractory patients with focal onset seizures did not meet its primary success measure Secondary measure, the 50% response rate, was met and seizure reduction during the second half of the study on higher dose (30 mg) was more pronounced Vormatrigine was generally well-tolerated; adverse event-related discontinuations were less than 10% Approximately 90% of patients from the vormatrigine arm transitioned to and remain in the open label extension (OLE) study Praxis is pausing enrollment in the POWER2 study to reassess the vormatrigine program and determine potential modifications BOSTON, June 01, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced results from the Phase 2/3 POWER1 study evaluating vormatrigine in patients with focal onset seizures (FOS). “While the results for POWER1 were not what we hoped for, we are encouraged by the signal we saw on the higher dose arm, the low discontinuation rate and solid safety profile,” said Marcio Souza, President and Chief Executive Officer of Praxis.

Praxis Precision Medicines NASDAQ: PRAX said it is preparing for two potential U.S. product launches while advancing several late-stage clinical programs, as management outlined first-quarter 2026 results and pipeline updates on the company's earnings call.