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Clinical Trial News

Sandoz Plans Generic Semaglutide Launch in Canada with Up to 70% Price Reduction

  • Swiss generic manufacturer Sandoz plans to launch unbranded semaglutide weight-loss drugs in Canada at discounts of up to 70% compared to branded versions once patents expire next year.
  • CEO Richard Saynor indicated pricing could drop to $40-50 per month compared to current branded medications priced between $200-400 monthly.
  • The move addresses surging global demand for weight-loss and diabetes drugs, with potential to expand patient access by two to three times current market size.
  • Sandoz joins other companies like Biocon in preparing generic versions of blockbuster GLP-1 medications as patent protections begin expiring.

Taconic and Cyagen Form Strategic Partnership to Expand Access to 16,000+ Genetically Engineered Mouse Models

AIDrug Discovery
  • Taconic Biosciences and Cyagen Biosciences announced a strategic partnership to provide preclinical researchers with streamlined access to Cyagen's library of over 16,000 genetically engineered mouse models.
  • Taconic will serve as the exclusive distributor of Cyagen's animal model library in North America and Europe, combining AI-generated models with world-class production services.
  • The collaboration expands Taconic's existing library from 4,500 to over 20,500 mouse models, including knockout, conditional knockout, and Cre-recombinase expressing models for disease research.
  • The partnership aims to accelerate drug discovery across multiple therapeutic areas including neurodegeneration, rare diseases, immuno-oncology, and metabolic disorders.

Health Canada Approves Dyanavel XR Extended-Release Amphetamine for ADHD Treatment in Adults and Children

Drug Approval
  • Health Canada has approved Dyanavel XR, an extended-release amphetamine formulation available as both tablets and oral suspension, for treating ADHD in adults 18 years and older and children aged 6-12 years.
  • The medication utilizes novel LiquiXR extended-release delivery technology and represents the first and only extended-release oral suspension and chewable tablet amphetamine approved in Canada.
  • Dyanavel XR demonstrates significant onset of action at one hour post-dose with a 13-hour duration of therapy, addressing the needs of ADHD patients who affect approximately 3-5% of adults and 5-9% of children and adolescents.
  • The approval expands Kye Pharmaceuticals' ADHD portfolio in Canada, providing healthcare professionals with additional treatment options for optimizing ADHD management in both pediatric and adult populations.

METiS Technologies Raises RMB 400 Million Series D to Advance AI-Driven Nanodelivery Platform

  • METiS Technologies completed a RMB 400 million Series D financing round co-led by Beijing Medical and Health Industry Investment Fund and Daxing Industrial Investment Fund to accelerate AI-driven nanodelivery innovation.
  • The company launched the OpenCGT platform to address precision nanodelivery challenges and enable clinical translation of next-generation cell and gene therapies, with its first project supporting AccurEdit Therapeutics' liver-targeted CRISPR gene-editing therapy.
  • METiS has developed three proprietary AI platforms (AiLNP, AiRNA, and AiTEM) that simulate nanoscale interactions to enable rational design of next-generation nanomaterials for therapeutic applications across cancer, metabolic disorders, and neurodegenerative conditions.

Cyclacel's Plogosertib Shows Promise Against Biliary Tract Cancer in Preclinical Study

Oncology
  • Independent researchers found that biliary tract cancer cell lines demonstrated sensitivity to plogosertib, a PLK1 inhibitor, both as monotherapy and in combination treatments.
  • The study identified BUBR1 as a potential biomarker, with cancer cells showing high BUBR1 expression being more sensitive to plogosertib treatment.
  • Plogosertib showed synergistic effects when combined with ATR inhibitors, suggesting a promising therapeutic strategy for treating this aggressive cancer with poor prognosis.
  • Early Phase 1 clinical data indicate plogosertib is well-tolerated with no dose-limiting toxicity observed across five dosing schedules.

Syndax Reports Strong Q2 2025 Results with Revuforj Revenue Growth and Pending FDA Approval for NPM1 AML

Monoclonal AntibodyDrug Approval
  • Syndax Pharmaceuticals reported $28.6 million in Revuforj net revenue for Q2 2025, representing a 43% increase over the first quarter despite approximately one-third of patients pausing treatment for stem cell transplants.
  • The FDA granted Priority Review to Syndax's supplemental New Drug Application for Revuforj in relapsed/refractory mutant NPM1 acute myeloid leukemia, with a PDUFA action date of October 25, 2025.
  • Niktimvo generated $36.2 million in net revenue during its first full quarter of launch, with Syndax recording $9.4 million in collaboration revenue from its 50% profit-sharing agreement with Incyte.
  • The company maintains $517.9 million in cash and investments, which management expects will fund operations to profitability alongside growing product revenues from both approved therapies.

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

Breakthrough Study Reveals Hidden Cancer Cells in 42% of Ovarian Cancer Patients in Clinical Remission

  • A multi-institutional study found that 42% of ovarian cancer patients who achieved clinical remission after first-line therapy still harbored minimal residual disease (MRD) detectable through second-look laparoscopy.
  • Patients with surgical MRD showed significantly worse progression-free survival (HR, 2.9) and overall survival (HR, 7.7) compared to those without detectable residual disease.
  • Advanced spatial transcriptomic and proteomic profiling of MRD samples identified specific druggable targets and biological features like hypoxia signaling and immune evasion.
  • Circulating tumor DNA (ctDNA) blood tests demonstrated potential as a non-invasive tool for MRD detection, with ctDNA-positive status correlating with inferior survival outcomes.

Vertex Pharmaceuticals Discontinues VX-993 Development After Phase 2 Failure in Acute Pain

  • Vertex Pharmaceuticals announced that its experimental non-opioid pain reliever VX-993 failed to significantly outperform placebo in a Phase 2 trial for acute pain treatment.
  • The company will discontinue development of VX-993 as a single-agent medicine for acute pain, with CEO Reshma Kewalramani stating they do not expect it to be superior to existing NaV1.8 inhibitors.
  • VX-993 was designed as a next-generation version of Vertex's recently approved pill Journavx, with potential for higher dosing and IV infusion formulation.
  • Despite the acute pain setback, Vertex will continue testing VX-993 in a separate trial for patients with diabetes who have chronic nerve pain.

A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

NCT06619847CompletedPhase 2
Vertex Pharmaceuticals Incorporated
Posted 10/29/2024

First Commercial Brain Gene Therapy Treatments Delivered in US Using ClearPoint Neuro's SmartFlow Cannula

FDA ApprovalRare DiseaseNeurology
  • The first commercial gene therapy treatments ever delivered directly to the brain in the United States have been successfully performed using ClearPoint Neuro's SmartFlow Neuro Cannula to administer KEBILIDI for AADC deficiency.
  • KEBILIDI (eladocagene exuparvovec-tneq) is delivered directly to the putamen region of the brain through stereotactic neurosurgery, with the SmartFlow cannula being the only FDA-authorized device for this administration.
  • ClearPoint Neuro reported record clinical activity in July with 17 global patients treated across 11 different drug platforms, while nine of the company's partners have now been accepted into FDA expedited review programs.
  • New ICD-10 codes specific to neuro infusions will become effective October 1, 2025, to assist in tracking commercial use of brain-delivered therapies.

Redwire Launches SpaceMD to Commercialize Space-Grown Pharmaceutical Crystals

  • Redwire has established SpaceMD, a new subsidiary focused on commercializing pharmaceutical crystal growth in microgravity using its PIL-BOX technology platform.
  • The company has successfully crystallized 17 compounds on the International Space Station across 28 PIL-BOX missions, including critical molecules like insulin.
  • SpaceMD announced its first licensing agreement with ExesaLibero Pharma to enhance the small-molecule drug ELP-004 for treating bone erosion diseases.
  • The partnership represents a shift from experimental space medicine to full commercialization, with SpaceMD receiving royalties from resulting pharmaceutical products.

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