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Argenx presents new Efgartigimod data at EULAR 2025

Argenx presents new Efgartigimod data at EULAR 2025

argenx (ARGX) SE 'announced the presentation of positive results from Phase 2 studies evaluating VYVGART in Sjogren's disease and idiopathic inflammatory myopathies at the European Congress of Rheumatology, EULAR 2025, from June 11 – 14 in Barcelona, Spain. argenx also announced that the FDA has granted efgartigimod Fast Track designation for the treatment of primary Sjogren's disease.'
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Spark Biomedical Completes Enrollment in a Neurostimulation Pivotal Trial for Opioid Use Disorder
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Spark Biomedical Completes Enrollment in a Neurostimulation Pivotal Trial for Opioid Use Disorder

Final enrollment concludes for Spark Biomedical's pivotal study investigating a non-invasive, drug-free neurostimulation therapy aimed at improving treatment retention for adults with opioid use disorder. Dallas, TX, June 12, 2025 (GLOBE NEWSWIRE) -- Spark Biomedical, a leader in wearable neurostimulation technology, has completed enrollment for its pivotal clinical trial, which aims to improve treatment retention for adults with opioid use disorder. Funded by the National Institute on Drug Abuse (NIDA) under the HEAL Initiative, the trial was conducted in partnership with the Hazelden Betty Ford Foundation and Gaudenzia. With relapse rates exceeding 70% among individuals with opioid use disorder and synthetic opioids like fentanyl driving overdose deaths to record highs, the need for innovative interventions has never been greater. Spark Biomedical's study investigated the use of wearable transcutaneous auricular neurostimulation (tAN® therapy) as a novel method to improve acute and long-term recovery. Additionally, the study examined the potential synergistic effects of tAN and two other approved medications for opioid use disorder (MOUD), lofexidine and XR-naltrexone. By helping individuals stay engaged in treatment longer, the trial seeks to support lasting recovery without additional opioid-based medications. Spark Biomedical's Co-founder & Chief Science Officer, Dr. Navid Khodaparast, Ph.D., shared, 'Completing enrollment marks a critical milestone in advancing transcutaneous auricular neurostimulation as a non-invasive, drug-free therapy for opioid use disorder. This study not only evaluates the standalone efficacy of wearable neurostimulation in enhancing treatment retention but also explores its potential to synergize with established pharmacotherapies.' 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Pluristyx Launches PluriForm™ Organoid Kit, Slashing Weeks Off Organoid Development Timelines
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Pluristyx Launches PluriForm™ Organoid Kit, Slashing Weeks Off Organoid Development Timelines

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FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025
FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

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FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

Geneva, Switzerland & Waltham, Mass., United States: FDA is expected to notify Innoviva Specialty Therapeutics regarding its decision to conduct an Advisory Committee Meeting in the Day 74 letter If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). 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In a pivotal Phase 3 clinical trial, zoliflodacin demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection with a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ('IST'), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ('GSK'). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to . For information about Innoviva Specialty Therapeutics, go to . ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash

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