MedPath

Clinical Trial News

Supernus Pharmaceuticals Acquires Sage Therapeutics for Up to $795 Million, Securing Postpartum Depression Drug Zurzuvae

Drug Approval
  • Supernus Pharmaceuticals agreed to acquire Sage Therapeutics for up to $795 million, offering $8.50 per share in cash plus contingent value rights worth $3.50 per share based on sales milestones.
  • The deal significantly exceeds Biogen's rejected $469 million unsolicited offer from January 2025, providing Sage shareholders with a 36% premium over previous trading levels.
  • Supernus gains exclusive U.S. rights to Zurzuvae, the only FDA-approved oral treatment for postpartum depression, which generated $36.1 million in 2024 sales and $13.8 million in Q1 2025.
  • The acquisition allows Supernus to diversify its CNS portfolio beyond its existing Parkinson's disease and ADHD treatments, while positioning the company for significant growth if Zurzuvae reaches projected sales milestones.

Liso-cel Achieves 95.5% Response Rate in Relapsed/Refractory Marginal Zone Lymphoma

CAR-TOncology
  • Lisocabtagene maraleucel (liso-cel) demonstrated a 95.5% overall response rate and 62.1% complete response rate in 66 patients with relapsed/refractory marginal zone lymphoma in the TRANSCEND FL trial.
  • The therapy showed durable responses with 24-month duration of response, progression-free survival, and overall survival rates of 88.6%, 85.7%, and 90.4%, respectively.
  • Safety profile remained consistent with previous reports, with 76% experiencing any-grade cytokine release syndrome and only 4% experiencing grade 3 events.
  • The results address a significant unmet need for patients with marginal zone lymphoma, where median overall survival after multiple relapses is currently 3 to 5 years.

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Single Psilocybin Dose Provides Two-Year Depression Relief in Cancer Patients

  • A phase 2 clinical trial demonstrated that a single 25 mg dose of psilocybin combined with psychological support provided sustained depression relief for 53.6% of cancer patients over two years.
  • Half of the 28 cancer patients with major depressive disorder maintained significant depression reduction and remission throughout the entire two-year follow-up period.
  • The treatment also reduced anxiety symptoms in 42.9% of patients at the two-year mark, offering a potentially paradigm-changing alternative to conventional antidepressants.
  • A randomized, double-blind trial is currently underway to evaluate up to two doses of psilocybin versus placebo for treating depression and anxiety in cancer patients.

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

NCT07002034RecruitingPhase 2
Reunion Neuroscience Inc
Posted 7/30/2025

RE104 Safety and Efficacy Study in Postpartum Depression

NCT06342310CompletedPhase 2
Reunion Neuroscience Inc
Posted 6/14/2024

ViroGates and GENSPEED Achieve Breakthrough in Point-of-Care Chronic Inflammation Testing for Longevity Market

  • ViroGates and GENSPEED have successfully demonstrated proof of concept for their enhanced suPARnostic® POC+ product, achieving improved sensitivity for measuring chronic inflammation biomarkers in the 2-6 ng/mL range critical for longevity testing.
  • The collaboration has overcome previous limitations in precision and consistency at lower suPAR levels by modifying system components and procedures, bringing assay results closer to ELISA standards.
  • The improved point-of-care test uses only finger-prick blood and delivers results in approximately 20 minutes, enabling suPAR testing in smaller healthcare settings without access to larger analyzers.
  • Both companies plan to launch the enhanced product by the end of Q4 2025, pending final validation, with equal cost-sharing demonstrating their commitment to innovation in longevity diagnostics.

MBX Biosciences Submits IND Application for Once-Monthly Obesity Drug MBX 4291

  • MBX Biosciences has submitted an Investigational New Drug application to the FDA for MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug designed for once-monthly administration in obesity treatment.
  • The drug demonstrated similar weight loss efficacy to tirzepatide in preclinical studies while showing extended duration of action, supporting its potential for monthly dosing with improved gastrointestinal tolerability.
  • Pending IND clearance, the company plans to initiate a Phase 1 clinical trial in healthy overweight volunteers during the third quarter of 2025.
  • MBX 4291 was developed using the company's proprietary Precision Endocrine Peptide platform, which aims to overcome limitations of current peptide therapies through optimized pharmaceutical properties.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity

NCT07142707RecruitingNot Applicable
MBX Biosciences
Posted 9/3/2025

Novo Nordisk Loses Canadian Semaglutide Patent Protection Over Missed $450 Fee, Opening Door to Generics in 2026

  • Novo Nordisk permanently forfeited Canadian patent protection for semaglutide after failing to pay a routine $450 maintenance fee in 2019, clearing the path for generic competitors.
  • The patent lapse affects Ozempic and Wegovy, which generated approximately $2.5 billion in Canadian sales last year, making Ozempic the nation's top-selling drug.
  • Generic manufacturers including Sandoz, Hikma Pharmaceuticals, and Aspen Pharmacare have confirmed semaglutide dossiers ready for launch once data exclusivity expires in January 2026.
  • The decision also invalidates Novo's certificate of supplementary protection that would have extended exclusivity until March 2028, potentially costing the company two additional years of market protection.

BDD Pharma's OralogiK System Advances Timed-Release Drug Delivery for ADHD and Rheumatoid Arthritis

  • BDD Pharma has developed OralogiK, a breakthrough tablet technology that releases medication at precisely timed intervals to optimize therapeutic outcomes for conditions like ADHD and rheumatoid arthritis.
  • The system allows patients to take medication before bedtime, with the drug releasing during sleep to provide symptom relief upon waking, eliminating morning pain and stiffness.
  • The company's first OralogiK therapy for ADHD is expected to launch next year, offering once-daily dosing instead of multiple daily doses.
  • BDD Pharma recently opened a £2 million GMP manufacturing facility in Glasgow to accelerate development and maintain Scottish production capabilities.

First Patient Treated with Novel B-Cell Targeting Therapy for Myasthenia Gravis in Phase III Trial

Rare Disease
  • The first patient worldwide has been treated with Remibrutinib, a novel B-cell targeting therapy for Myasthenia Gravis, marking the start of an international Phase III clinical trial at HonorHealth Research Institute.
  • This represents the first time a drug has targeted B cells in Myasthenia Gravis treatment, offering a new mechanism of action that blocks a different part of the neuro-muscular-junction pathway than existing therapies.
  • The rare autoimmune disease affects fewer than 200 people per million, causing muscle weakness symptoms that severely impact daily activities like brushing teeth and getting dressed.
  • If successful, the trial could lead to FDA approval for Remibrutinib in Myasthenia Gravis, with the drug already approved for certain cancer types.

Alzamend Neuro Completes $5 Million Financing to Advance Five Phase II Trials for AL001 Lithium Therapy

  • Alzamend Neuro completed a $5 million private placement months ahead of schedule to fund five Phase II clinical trials of AL001 "Lithium in Brain" studies at Massachusetts General Hospital.
  • The company's AL001 drug candidate uses patented ionic cocrystal technology to deliver lithium via a therapeutic combination of lithium, salicylate and L-proline for treating neurological and psychiatric conditions.
  • Five Phase II trials are planned across multiple indications, with the first healthy subject trial initiated in May 2025 and additional trials for bipolar disorder, Alzheimer's disease, major depressive disorder and PTSD expected to commence through Q4 2025.
  • The financing targets treatment solutions for over 43 million Americans afflicted with Alzheimer's disease, bipolar disorder, major depressive disorder and post-traumatic stress disorder.

ZIRCON Phase 3 Trial Demonstrates High Accuracy of Novel PET Tracer for Kidney Cancer Detection

  • The ZIRCON phase 3 trial evaluated 89Zr-TLX250 PET tracer for characterizing small renal masses, achieving greater than 85% accuracy in identifying clear cell renal cell carcinoma.
  • The novel molecular imaging approach demonstrated exceptional positive predictive value of 93-95% for ccRCC, with all positive cases indicating malignancy even when not specifically ccRCC.
  • This represents a significant advance in noninvasive kidney cancer diagnosis, potentially reducing unnecessary interventions while providing actionable clinical information for treatment decisions.

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

NCT03849118CompletedPhase 3
Telix Pharmaceuticals (Innovations) Pty Limited
Posted 8/15/2019

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.