Phase III trial

#BioNTech #Head and neck cancer #Immunotherapy #mRNA #Phase III trial

BioNTech’s mRNA immunotherapy fails to meet primary endpoint

BioNTech has announced the first topline results from the AHEAD-MERIT Phase II/III clinical trial for its investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran or tenu-ra).  The clinical trial is evaluating BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent… Read More

#Cancer Research #News

Closed until further notice
#Antibody Fragments #argenx #Biologics #Phase III trial

Argenx discontinues Phase III Sjögren’s disease trial

argenx has revealed that it will discontinue the Phase III UNITY study of Vyvgart Hytrulo (efgartigimod subcutaneous – efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate-to-severe Sjögren’s disease.  The company said the decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop… Read More

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#Bipolar #Johnson & Johnson #Neuroscience #Phase III trial #Psychiatry

Phase III study supports lumateperone use in bipolar mania

Johnson & Johnson has announced positive topline results from a Phase III study evaluating Caplyta (lumateperone) for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder.   The study met its primary endpoint, with Caplyta demonstrating a statistically significant and rapid… Read More

#News

Novartis
#Monoclonal antibodies #Neurodegenerative disorders #Novartis #Phase III trial

Novartis faces September’s fourth trial disappointment with ALS drug

Novartis has revealed plans to pause development of Lifonebart (VHB937), an experimental monoclonal antibody drug targeting the TREM2 protein to treat neurodegenerative diseases.  The news comes just days after the company announced its Phase III trial of antibody oligonucleotide conjugate (AOC) del-desiran had failed.  VHB937… Read More

#News #Trending News

Lung cancer
#Johnson & Johnson #Lung cancer #Non-small cell lung cancer (NSCLC) #Oncology #Phase III trial

Amivantamab shown to extend survival in advanced NSCLC

Johnson & Johnson has announced final overall survival (OS) results from the Phase III PAPILLON study of first-line intravenous (IV) Rybrevant (amivantamab).  The fully-human EGFR-MET bispecific antibody was assessed with carboplatin-pemetrexed chemotherapy, versus chemotherapy alone, in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth… Read More

#Cancer Research #News #Trending News

#Antisense Oligonucleotides (ASOs) #Orphan drugs #Phase III trial #Rare disease #Ultragenyx

Ultragenyx’s ASO for Angelman Syndrome fails at Phase III

Ultragenyx Pharmaceutical has revealed that its Phase III Aspire study for apazunersen (GTX-102) in Angelman syndrome did not achieve its primary endpoint of change from Baseline in Bayley-4 cognitive raw score.  The trial also failed to achieve the key secondary endpoint of net response in Multidomain Responder… Read More

#News

Retatrutide
#Eli Lilly #GLP-1 #Obesity #Phase III trial #Weight loss

Phase III trials confirm benefits of Lilly’s triple agonist retatrutide

Eli Lilly has announced positive topline results from TRIUMPH-2 and TRIUMPH-3, two pivotal Phase III trials evaluating retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist.   In both studies, retatrutide met the primary endpoint, delivering substantial weight loss in adults with obesity and some… Read More

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Bile duct
#ASCO #Incyte #Oncology #Phase III trial

A potentially practice-changing advance in bile duct cancer

Results presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from the Phase III FIGHT-302 trial showed that Incyte’s pemigatinib (Pemazyre), significantly improved progression-free survival in the first-line setting in cholangiocarcinoma (bile duct cancer).  The drug was compared with gemcitabine and cisplatin, a long-standing… Read More

#Cancer Research #Editor's Choice #News

#Eli Lilly #GLP-1 #Obesity #Phase III trial #Weight loss

Lilly’s new triple agonist delivers weight loss equal to bariatric surgery

Eli Lilly has announced positive topline results from TRIUMPH-1, a Phase III clinical trial evaluating the efficacy and safety of retatrutide, a GIP, GLP-1,and glucagon triple hormone receptor agonist, in adults with obesity or overweight and at least one weight-related comorbidity and without diabetes.   At 80 weeks,… Read More

#News

Boy tests his blood sugar levels at home
#GLP-1 #Novo Nordisk #Paediatrics #Phase III trial #Type 2 diabetes

Semaglutide could be first oral GLP-1 RA therapy for children

Positive topline results from Novo Nordisk’s PIONEER TEENS, a Phase IIIa trial evaluating oral semaglutide for type 2 diabetes demonstrated a superior reduction in HbA1c (a measure of blood sugar control) over placebo.  The trial, in children and adolescents aged 10–17 years with type 2 diabetes, also… Read More

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Cardiovascular system
#Diabetes #Eli Lilly #Obesity #Phase III trial #Weight loss

Lilly publishes data confirming Foundayo’s safety profile

Eli Lilly has shared positive topline results from the Phase III ACHIEVE-4 trial evaluating the efficacy and safety of Foundayo (orforglipron), compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk.   ACHIEVE-4, the largest and longest study of Foundayo… Read More

#News

Ovarian cancer
#Corcept Therapeutics #Oncology #Ovarian cancer #Phase III trial

Combo treatment new SOC in platinum-resistant ovarian cancer

Corcept Therapeutics has shared final overall survival data from its pivotal Phase III ROSELLA trial of Lifyorli (relacorilant) combined with the chemotherapeutic agent nab-paclitaxel in patients with platinum-resistant ovarian cancer.  The results were shared in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) 2026… Read More

#Cancer Research #News #Trending News

Obese man measures his waist
#Diabetes #Eli Lilly #GLP-1 #Obesity #Phase III trial

Lilly’s triple agonist significantly reduces A1C and weight

Eli Lilly has announced positive topline results from TRANSCEND-T2D-1, a Phase III clinical trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise.   The trial enrolled adults diagnosed with type 2… Read More

#News

Medical professional examining mammogram
#Breast cancer #Oncology #Phase III trial #Roche

Roche breast cancer study fails to meet primary objective

Roche has announced that its Phase III persevERA Breast Cancer study did not meet the primary objective of a statistically significant improvement in progression-free survival, but a numerical improvement was observed.  The trial assessed giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal… Read More

#Cancer Research #News

CRISPR gene editing
#Advanced Therapies #FDA #Gene therapy #Intellia Therapeutics #Phase III trial

Regulator lifts clinical hold on Intellia’s gene therapy trials

The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the MAGNITUDE Phase III clinical trial of nexiguran ziclumeran (nex-z) for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM).  The clinical holds on the INDs for MAGNITUDE and… Read More

#News #Regulatory #Trending News