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Clinical Trial News

Nyxoah's Genio System Shows Strong Patient Satisfaction and Efficacy in DREAM Pivotal Study Publication

  • Nyxoah's DREAM pivotal study data published in the Journal of Clinical Sleep Medicine demonstrates 90% patient satisfaction with the Genio hypoglossal neurostimulation system for obstructive sleep apnea treatment.
  • The study achieved primary endpoints with 63.5% AHI responder rate and 71.3% ODI responder rate at 12 months, while showing high device usage with 85.9% of participants using the device over 70% of nights.
  • Genio's bilateral stimulation resulted in a 66.6% median reduction in supine AHI and significant improvements in quality-of-life measures, including a 3.4-point reduction in Epworth Sleepiness Score.
  • The leadless, battery-free design addresses patient needs for OSA treatment, particularly for those who fail or refuse CPAP therapy, with safety results comparable to other neuromodulation therapies.

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

NCT03868618Active, Not RecruitingNot Applicable
Nyxoah S.A.
Posted 10/14/2020

Torrent Pharmaceuticals Prepares First-Wave Semaglutide Launch Following Patent Expiry

  • Torrent Pharmaceuticals is conducting Phase 3 clinical trials for oral semaglutide and has partnered for injectable versions, positioning itself for launch within 1-2 years following Novo Nordisk's patent expiry.
  • The company plans to manufacture the active pharmaceutical ingredient in-house at its Gujarat facility while potentially outsourcing fill-finish operations to optimize production costs.
  • Torrent's entry into the semaglutide market could address unmet demand in India's expanding obesity and diabetes segment, where GLP-1 drugs are gaining traction among clinicians and patients.
  • The strategic move represents a significant addition to Torrent's chronic medicine portfolio as generic drugmakers prepare for the high-stakes market opportunity post-patent expiry.

XVIVO Heart Preservation Technology Faces 6-12 Month CE Approval Delay Despite Promising Clinical Results

  • XVIVO's heart perfusion solution faces a 6-12 month delay in CE approval due to additional scientific consultation requirements at EU competent authorities, despite main system components already receiving approval.
  • The company's European multicenter heart trial demonstrated a 76% risk reduction in severe primary graft dysfunction (PGD) and improved one-year survival rates of 92% versus 86% in the control group.
  • The delay affects access to potentially life-saving heart preservation technology for European patients awaiting transplants, with CEO expressing disappointment over the regulatory setback.

Asahi Kasei to Build Fourth Planova Virus Filter Plant in Japan with Government Support

  • Asahi Kasei Life Science announced plans to construct a new spinning plant for Planova virus removal filters in Nobeoka City, Japan, with construction beginning July 2026 and operations starting January 2030.
  • The facility will be the company's fourth spinning plant for hollow-fiber cellulose membrane filters, backed by a grant from Japan's Ministry of Economy, Trade, and Industry under the Biopharmaceutical Manufacturing Project.
  • The expansion responds to accelerating global demand driven by the biopharmaceutical market forecast to surpass $500 billion by 2032 with 8.2% compound annual growth from 2022 to 2032.
  • The new plant will focus on producing Planova filters S20N, 15N, 20N, 35N, and 75N to enhance global supply chain resilience and strengthen the company's position in virus filtration for biologics.

GEN Pharmaceuticals Reports Positive Phase 1 Results for Novel Alzheimer's Drug SUL-238

  • GEN Pharmaceuticals announced positive Phase 1 trial results for SUL-238, a first-in-class mitochondria-directed drug candidate for Alzheimer's disease and other neurodegenerative conditions.
  • The study demonstrated that single oral doses of 50-2000 mg were safe and well-tolerated in 53 healthy elderly volunteers, with favorable pharmacokinetics and high brain penetration.
  • SUL-238 showed impressive cerebrospinal fluid penetration rates of 21.1% at 2 hours and 74.2% at 8 hours post-dose, supporting its potential for treating brain disorders.
  • The hibernation-derived small molecule targets mitochondrial dysfunction and has shown efficacy in preclinical models of neurodegenerative, cardiovascular, and renal diseases.

Pluristyx Secures Strategic Investment to Advance iPSC Technologies and Gene-Edited Cell Lines

Gene Editing
  • Pluristyx completed a funding round led by BioLife Solutions and BroadOak Capital Partners to expand its induced pluripotent stem cell technology portfolio.
  • The investment will support expansion of clinical-grade cell lines incorporating proprietary FailSafe® and iACT™ engineering with hypoimmune genetic modifications.
  • Funding will also advance the recently launched PluriForm™ kit for organoid generation and complex test systems development.
  • The company's iPSC products are designed to serve as universal raw materials for next-generation cell-based therapies targeting currently untreatable diseases.

Global Alzheimer's Platform Foundation and Genentech Partner to Enhance Diversity in Alzheimer's Clinical Trials

  • The Global Alzheimer's Platform Foundation and Genentech announced a collaboration to expand access to Alzheimer's clinical trials for underrepresented communities, including racial and ethnic minorities, women, and economically disadvantaged individuals.
  • The partnership will leverage GAP's Site Alliance for Understudied Communities and Genentech's Advancing Inclusive Research Site Alliance to remove barriers to clinical research participation.
  • Genentech will activate specialized clinical trial sites from GAP's network for several Alzheimer's disease studies, focusing on community-based education and inclusive recruitment practices.
  • The collaboration aims to ensure that scientific advances in Alzheimer's disease benefit all communities by improving representation and building trust in clinical research.

Qualigen Therapeutics Secures $4.5 Million in Series A-3 Preferred Stock Financing to Advance Cancer Therapeutics Pipeline

OncologyOrphan Drug
  • Qualigen Therapeutics completed a $4.5 million private placement of Series A-3 Preferred Stock on July 28, 2025, with institutional and accredited investors.
  • The financing will support working capital needs for the clinical-stage biotechnology company's cancer therapeutics development programs.
  • Qualigen's pipeline includes QN-302 for pancreatic cancer, QN-247 for hematologic malignancies, and RAS oncogene inhibitors, all targeting high unmet medical needs.
  • The preferred stock is convertible into 1,607,143 common shares at $2.80 per share, with Univest LLC serving as exclusive placement agent.

U.S. POINTER Study Demonstrates Structured Lifestyle Interventions Significantly Improve Cognitive Function in At-Risk Older Adults

  • The U.S. POINTER study, a $50 million phase 3 randomized controlled trial, found that both structured and self-guided lifestyle interventions improved cognition in older adults at risk for dementia over two years.
  • Participants in the structured intervention group showed statistically significantly greater improvements in global cognitive composite scores compared to the self-guided group (0.029 SD per year, P = .0008).
  • The structured program involved 38 guided peer meetings with specific goals for exercise, MIND diet adherence, cognitive training, and regular clinician check-ins, while the self-guided group attended only 6 meetings.
  • The trial enrolled 2,111 diverse participants with 89% retention, including 30% from ethnoracial minority groups and 30% APOE-e4 carriers at higher risk for neurodegenerative disorders.

Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

NCT01041989Active, Not RecruitingNot Applicable
Finnish Institute for Health and Welfare
Posted 9/1/2009

Avacta Completes Transition to Pure-Play Therapeutics with £2.2M Coris Sale

Precision MedicineOncology
  • Avacta Group has agreed to sell Coris Bioconcept SRL to 3B BlackBio Dx Ltd for £2.15 million upfront plus potential earn-outs of up to £615,000, completing its transformation into a pure-play therapeutics company.
  • The sale represents the final step in Avacta's strategic pivot away from diagnostics, following the earlier divestment of Launch Diagnostics in March 2025.
  • Proceeds will fund advancement of Avacta's preCISION platform for peptide drug conjugates targeting precision oncology treatments.
  • The transaction extends Avacta's cash runway into Q1 2026 and allows full focus on its tumor-targeting therapeutic pipeline powered by fibroblast activation protein technology.

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