$PRAX News
Last published 22h ago
- 22h agoPRAXPraxis Precision Medicines Details Launch Readiness for Relutrigine and Ulixacaltamide and Outlines Expanded Pipeline in Preparation to be the Preeminent CNS Biotech at Investor DayGlobeNewswireDetailed launch readiness for relutrigine and ulixacaltamide, with PDUFA target action dates of December 27, 2026 and January 29, 2027
- 1d agoBBIOVRTXGILDVTRS+1A Run of FDA Target Dates Fills the Biotech Calendar From Late November to Year EndPR NewswireBiotech Today News Commentary - The final weeks of 2026 carry a cluster of U.S. Food and Drug Administration (FDA) target action dates for...
- 4d agoPRAXPRAXIS PRECISION MEDICINES, INC. (PRAX) - GUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - PRAXIS PRECISION MEDICINES INCEarnings Call TranscriptsAll right, I think we're live now. Good morning, everyone. Welcome to our third annual, or Guggenheim's third annual health care innovation conference. My name is Yadin Suneja, one of the biotech analysts here. Our next
- 4d agoPRAXGUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - PRAXIS PRECISION MEDICINES INCEarnings Call TranscriptsAll right, I think we're live now. Good morning, everyone. Welcome to our third annual, or Guggenheim's third annual health care innovation conference. My name is Yadin Suneja, one of the biotech analysts here. Our next
- 4d agoPRAXPraxis Precision Medicines, Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 4d agoPRAXPraxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2026 Financial ResultsGlobeNewswireFDA reviews of relutrigine, with PDUFA target action date of December 27, 2026, and ulixacaltamide HCI, with PDUFA target action date of January 29, 2027, are ongoing Topline results from the EMERALD study of
- 4d agoPRAXPraxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2026 Financial ResultsGlobeNewswireFDA reviews of relutrigine, with PDUFA target action date of December 27, 2026, and ulixacaltamide HCI, with PDUFA target action date of January 29, 2027, are ongoing
- 1w agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that
- 2w agoPRAXPraxis Precision Medicines Announces Third Quarter 2026 Financial Results Date, Investor Day and November Conference ParticipationGlobeNewswireBOSTON, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced it
- 2mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Sept. 03, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced
- 3mo agoPRAXPraxis Precision Medicines Second Quarter 2026 Financial Results Conference Call - PRAXIS PRECISION MEDICINES INCEarnings Call TranscriptsGood day, and thank you for standing by. Welcome to the Praxis Precision Medicine Second Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's prese
- 3mo agoPRAXPraxis Precision Medicines Provides Corporate Update and Reports Second Quarter 2026 Financial ResultsGlobeNewswireMid-cycle meeting completed for ulixacaltamide HCl; FDA identified no major safety or efficacy concerns to date and does not plan to request an advisory committee meeting; PDUFA date of January 29, 2027 Mid-cycle
- 3mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that
- 3mo agoPRAXPraxis Precision Medicines to Report Second Quarter 2026 Financial Results on Thursday, August 6, 2026GlobeNewswireBOSTON, July 30, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced it
- 4mo agoPRAXPraxis Precision Medicines and Remagine Labs Announce Strategic Collaboration to Develop Transdermal Ulixacaltamide for Essential TremorGlobeNewswireCollaboration 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
- 4mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, 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
- 4mo agoPRAXPraxis Precision Medicines Announces Extension Period for Relutrigine for Treatment of SCN2A and SCN8A Developmental and Epileptic EncephalopathiesGlobeNewswireFDA 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
- 4mo agoPRAXPraxis 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 VariantsGlobeNewswireThe 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),
- 5mo agoPRAXPraxis Precision Medicines to Participate in Goldmans Sachs 47th Annual Global Healthcare ConferenceGlobeNewswireBOSTON, 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
- 5mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, 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
- 5mo agoPRAXPraxis Precision Medicines Provides Vormatrigine Program UpdateGlobeNewswirePOWER1 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
- 6mo agoPRAXPraxis Precision Medicines Provides Corporate Update and Reports First Quarter 2026 Financial ResultsGlobeNewswireFDA accepted the new drug application (NDA) for ulixacaltamide in Essential Tremor with a PDUFA target action date of January 29, 2027, and the NDA for relutrigine, with priority review, in SCN2A and SCN8A developmental
- 6mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, May 05, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that
- 6mo agoPRAXPraxis Precision Medicines to Report First Quarter 2026 Financial Results on Thursday, May 7, 2026, and Participate in Upcoming Investor ConferenceGlobeNewswireBOSTON, May 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
- 7mo agoPRAXPraxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential TremorGlobeNewswireFDA 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
- 7mo agoPRAXPraxis to Showcase Essential3, the First Positive Phase 3 Program in Essential Tremor, at AAN 2026GlobeNewswireEssential3 is the first positive Phase 3 program in essential tremor; ulixacaltamide has received FDA Breakthrough Therapy Designation, with data selected for plenary presentation at AAN 2026Praxis to present 3 oral
- 7mo agoPRAXPraxis Precision Medicines Announces Positive Results from the EMBRAVE Part A Trial of Elsunersen in Patients with SCN2A Early-Onset Developmental and Epileptic EncephalopathyGlobeNewswireElsunersen 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
- 7mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, 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
- 7mo agoPRAXPraxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEsGlobeNewswireFDA 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
- 8mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, March 04, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that
- 8mo agoPRAXPraxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial ResultsGlobeNewswireTwo new drug applications (NDA) for ulixacaltamide in essential tremor (ET) and for relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) have been submitted to the U.S. Food and Drug
- 9mo agoPRAXPraxis Precision Medicines to Report Fourth Quarter and Full Year 2025 Financial Results on Thursday, February 19, 2026, and Participate in Upcoming Investor ConferencesGlobeNewswireBOSTON, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced it
- 9mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that
- 10mo agoPRAXPraxis Precision Medicines Appoints Global Epilepsy Leader Dr. Orrin Devinsky as Head of Clinical StrategyGlobeNewswireBOSTON, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced the
- 10mo agoPRAXPraxis Precision Medicines Enters Its Next Chapter Following a Pivotal Year of ProgressGlobeNewswireTwo NDA submissions expected by mid-February 2026 for ulixacaltamide in essential tremor and relutrigine in SCN2A/8A-DEEs, both with Breakthrough Therapy Designation from the FDA Multiple registrational readouts
- 10mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous
- 10mo agoPRAXPraxis Precision Medicines Further Positioned for Next-Phase Growth with Key Board and Executive AppointmentsGlobeNewswireBOSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous
- 10mo agoPRAXPraxis Precision Medicines, Inc. Announces Pricing of $575 Million Public OfferingGlobeNewswireBOSTON, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous
- 10mo agoPRAXPraxis Precision Medicines, Inc. Announces Proposed Public OfferingGlobeNewswireBOSTON, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous
- 10mo agoPRAXPraxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential TremorGlobeNewswireThe Breakthrough Therapy Designation was granted based on the positive topline results from the Essential3 Phase 3 program in essential tremor Praxis remains on track to submit ulixacaltamide NDA in early 2026 based on
- 11mo agoPRAXPraxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026GlobeNewswireBOSTON, Dec. 11, 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
- 11mo agoPRAXPraxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic EncephalopathyGlobeNewswireClear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm,
- 11mo agoPRAXPraxis AES Wrap-up: Best-in-Class Potential Across Rare Pediatric and Adult EpilepsiesGlobeNewswirePositive Results in the EMBOLD study of relutrigine showed a 53% placebo-adjusted reduction in seizures (p < 0.0002), 66% increase in motor seizure-free days (p = 0.0340), broad and clinically meaningful functional
- 11mo agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Dec. 03, 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
- 11mo agoPRAXPraxis to present latest preclinical and clinical advancements across leading epilepsy portfolio at the 2025 American Epilepsy Society (AES) Annual MeetingGlobeNewswireBOSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system (CNS)
- 11mo agoPRAXPraxis Precision Medicines to Participate in Upcoming Fireside ChatGlobeNewswireBOSTON, Nov. 20, 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
- 1y agoPRAXPraxis Precision Medicines, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Nov. 06, 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
- 1y agoPRAXPraxis Precision Medicines to Participate in Upcoming Investor ConferencesGlobeNewswireBOSTON, Nov. 05, 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
- 1y agoPRAXPraxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2025 Financial ResultsGlobeNewswireAnnounced positive results from two pivotal Phase 3 Essential3 studies of ulixacaltamide HCl in essential tremor (ET); Pre-NDA meeting with FDA scheduled for Q4 2025 Plans to accelerate the development of relutrigine in
- 1y agoPRAXPraxis announces accelerated development path for relutrigine in SCN2A and SCN8A DEE patients following positive FDA feedbackGlobeNewswireComprehensive meeting with FDA conducted in Q3 in conjunction with Breakthrough Therapy Designation Key aspects of a potential NDA application discussed and aligned with the Agency Praxis plans to perform an interim