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Clinical Trial News

Influenza Pipeline Surges with 120+ Therapies as Moderna, AstraZeneca Lead Innovation Wave

Monoclonal AntibodyDrug Approval
  • The global influenza pipeline has expanded to include 120+ companies developing 120+ treatment therapies, with breakthrough innovations spanning vaccines, antibodies, and combination therapies.
  • Moderna's mRNA-1083 combination vaccine achieved primary endpoints in Phase III trials, demonstrating stronger immune responses than licensed comparator vaccines for both influenza and COVID-19.
  • AstraZeneca launched FluMist Home in August 2025, marking the first FDA-approved influenza vaccine for self-administration or caregiver delivery at home.
  • Leading pipeline candidates include Moderna's mRNA-1010 seasonal vaccine, SAB Biotherapeutics' broadly neutralizing antibody SAB-176, and innovative intranasal therapies targeting multiple respiratory viruses.

Quoin Pharmaceuticals Appoints Sally Lawlor as CFO to Navigate QRX003 Commercialization

Orphan DrugRare Disease
  • Quoin Pharmaceuticals has appointed Sally Lawlor as Chief Financial Officer, bringing over 20 years of pharmaceutical finance experience to guide the company through commercialization preparations.
  • The appointment comes as Quoin advances QRX003 through two pivotal clinical studies for Netherton Syndrome, with full enrollment expected in early to mid-Q1 2026.
  • QRX003 has received regulatory advantages including Orphan Drug Designation from the EMA and Rare Pediatric Disease Designation from the FDA.
  • The company reported $7.8 million in cash as of June 30, 2025, providing operational runway into Q1 2026 as it prepares for potential commercialization.

Merck KGaA Partners with Skyhawk Therapeutics in $2 Billion RNA Splicing Collaboration for Neurological Disorders

AI
  • Merck KGaA, Darmstadt, Germany has entered a strategic collaboration with Skyhawk Therapeutics valued at over $2 billion to discover novel RNA-targeting small molecules for neurological disorders with high unmet medical need.
  • The partnership leverages Skyhawk's proprietary SkySTAR platform, which uses computational biology and AI to design oral drug candidates that can cross the blood-brain barrier and correct RNA mis-splicing.
  • Skyhawk will lead discovery and preclinical development, while Merck will assume responsibility for further development and commercialization upon option exercise.
  • This collaboration adds to Skyhawk's growing portfolio of pharma partnerships, including a $1.8 billion alliance with Ipsen for neurological diseases and ongoing programs with Sanofi in oncology and immunology.

NewAmsterdam's Obicetrapib Receives EMA Validation for European Review Following Positive Phase 3 Results

Drug Approval
  • The European Medicines Agency has validated Marketing Authorization Applications for obicetrapib monotherapy and obicetrapib-ezetimibe combination therapy, marking a significant regulatory milestone for NewAmsterdam Pharma.
  • Phase 3 trials demonstrated clinically meaningful LDL-C reductions of 35-40% with obicetrapib monotherapy and approximately 50% with the combination therapy, both showing safety profiles comparable to placebo.
  • The partnership with Menarini Group provides NewAmsterdam with potential milestone payments up to €863 million and tiered double-digit royalties, while Menarini handles European commercialization responsibilities.
  • With cardiovascular disease causing 17.9 million deaths annually and many patients failing to reach LDL-C targets despite existing therapies, obicetrapib could address a significant unmet medical need.

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT05142722CompletedPhase 3
NewAmsterdam Pharma
Posted 12/15/2021

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT06005597CompletedPhase 3
NewAmsterdam Pharma
Posted 3/1/2024

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

NCT05425745CompletedPhase 3
NewAmsterdam Pharma
Posted 7/25/2022

NanoViricides' NV-387 Antiviral Drug Shows Potential to Prevent Cancer Metastasis Resurgence Through Anti-Inflammatory Effects

  • NanoViricides reports that its broad-spectrum antiviral drug NV-387 could help reduce metastatic cancer resurgence by preventing viral infections from awakening dormant cancer cells.
  • The drug has completed Phase I clinical trials and is advancing to Phase II, demonstrating effectiveness against multiple respiratory viruses while reducing inflammatory cytokine IL-6 levels.
  • Recent studies have linked viral infections and increased IL-6 inflammation to higher risk of metastatic cancer resurgence, particularly in COVID-19 and breast cancer patients.
  • NV-387 outperformed approved antiviral drugs including Tamiflu, Rapivab, and Xofluza in animal studies, showing superior lung protection and anti-inflammatory effects.

IQVIA and Veeva Systems Form Strategic Partnership to Accelerate Clinical Development and Commercial Operations

AI
  • IQVIA and Veeva Systems announced global clinical and commercial partnerships on August 18, 2025, resolving all pending legal disputes between the companies.
  • The partnership enables seamless integration of both companies' software, data, and services, including IQVIA data in Veeva platforms and Veeva software in IQVIA clinical trials.
  • Customers will benefit from accelerated database builds, study locks, and data delivery through combined clinical data management and EDC programming expertise.
  • The collaboration aims to help pharmaceutical companies bring treatments to market more efficiently and improve patient access to medical innovations.

Unicycive Therapeutics Secures Patent Protection for UNI-494 Kidney Disease Treatment Through 2040

  • Unicycive Therapeutics received U.S. Patent 12,377,082 for UNI-494 to treat chronic kidney disease, extending intellectual property protection until 2040.
  • UNI-494 is a novel nicotinamide ester derivative that functions as a selective ATP-sensitive mitochondrial potassium channel activator, targeting mitochondrial dysfunction in kidney disease.
  • The drug has received FDA orphan drug designation for preventing delayed graft function in kidney transplant patients and completed Phase I safety studies in healthy volunteers.
  • Acute kidney injury affects an estimated 2 million deaths worldwide annually, with survivors at increased risk of developing chronic kidney disease and end-stage renal disease.

ASTER 70 Trial Shows No Survival Benefit from Adjuvant Chemotherapy in Elderly Breast Cancer Patients

  • The ASTER 70 phase III trial involving 1,089 patients aged 70 and older with high-risk ER+HER2- breast cancer found no significant overall survival benefit from adding chemotherapy to hormone therapy.
  • After 7.8 years of follow-up, four-year survival rates were 90.5% with chemotherapy versus 89.3% with hormone therapy alone, while eight-year rates were 72.7% versus 68.3% respectively.
  • Patients receiving chemotherapy experienced significantly more grade 3 or higher adverse events (34% versus 9%) and reported worse quality of life including increased fatigue, pain, and digestive disorders.
  • The findings challenge current treatment standards and support more individualized approaches for elderly breast cancer patients based on age, frailty, and patient preferences rather than tumor biology alone.

Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment

NCT01564056Active, Not RecruitingPhase 3
UNICANCER
Posted 4/12/2012

Phase III IMvigor011 Trial Demonstrates Significant Survival Benefits for ctDNA-Guided Bladder Cancer Treatment

Precision Medicine
  • The randomized phase III IMvigor011 trial achieved positive topline results, showing statistically significant and clinically meaningful improvements in disease-free survival and overall survival for Signatera-positive muscle-invasive bladder cancer patients treated with atezolizumab.
  • This represents the first prospective phase III study in muscle-invasive bladder cancer to use a personalized, ctDNA molecular residual disease-guided approach for treatment selection.
  • Signatera-negative patients demonstrated excellent outcomes without adjuvant treatment, with 100% overall survival at 12 months and 98% at 18 months.
  • Natera plans to finalize its premarket approval application to the FDA for Signatera as a companion diagnostic for selecting MIBC patients for atezolizumab treatment after cystectomy.

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

NCT04660344Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2021

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

NCT03377491CompletedPhase 3
NovoCure Ltd.
Posted 2/10/2018

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

NCT04145622RecruitingPhase 1
Daiichi Sankyo
Posted 11/3/2019

Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

NCT04886804RecruitingPhase 1
Boehringer Ingelheim
Posted 7/2/2021

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 8/5/2019

Outlook Therapeutics Awaits Critical FDA Decision for Wet AMD Treatment ONS-5010

Drug Approval
  • Outlook Therapeutics' stock surged 11.97% in pre-market trading on August 18, 2025, as investors anticipate the FDA's decision on ONS-5010 (LYTENAVA) scheduled for August 27, 2025.
  • The investigational ophthalmic formulation of bevacizumab represents the company's second attempt at FDA approval after initial rejection in August 2023 due to chemistry, manufacturing, and controls issues.
  • ONS-5010 has already received European approval in May 2024 for wet age-related macular degeneration treatment and would receive 12 years of regulatory exclusivity if approved in the United States.
  • The company resubmitted its Biologics License Application in February 2025, addressing FDA concerns from the Complete Response Letter issued after the initial rejection.

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