Clinical Trials

Roche's dual GLP-1/GIP agonist enicepatide met both Phase II endpoints in type 2 diabetes, cutting HbA1c 2.65% and weight 15.5% at 48 weeks. #SyenzaNews #type2diabetes #GLP1 #obesity

COMP's July 2026 sitting recommended 12 orphan drug designations, withdrew four, and sharpened the test for significant benefit against authorised therapies. #SyenzaNews #OrphanDrugs #MarketAccess #RareDiseases

The FDA has granted full approval to Inluriyo plus Verzenio for ESR1-mutated metastatic breast cancer. In the Phase 3 EMBER-3 trial, the all-oral combination doubled median progression-free survival versus Inluriyo alone, at 11.1 months versus 5.5 months. #SyenzaNews #Oncology #MarketAccess

EMA's CHMP September 2026 meeting ended with positive opinions for 12 new medicines and 11 indication extensions. New approvals cover haemophilia A, ALK-positive lung cancer, myasthenia gravis, ovarian cancer, hidradenitis suppurativa and short bowel syndrome, plus the first biosimilar cleared under the tailored clinical pathway. #SyenzaNews #pharmaceuticals #drugdevelopment #innovation #MarketAccess

FDA approved finerenone (Kerendia) for CKD associated with type 1 diabetes, the first new treatment for this population in 30 years. The label rests on a six-month UACR reduction, not hard kidney outcomes, so payers and HTA agencies will each have to decide how much credit the surrogate deserves. #SyenzaNews #MarketAccess #CKD #Type1Diabetes

NICE has reversed its earlier rejection and now recommends Enhertu (trastuzumab deruxtecan) as a routine NHS option for HER2-low metastatic breast cancer after chemotherapy. The change follows an updated commercial deal and new EQ-5D-5L utility values validated in the DESTINY-Breast04 trial. #SyenzaNews #HTA #MarketAccess #BreastCancer

Novo Nordisk's STEP Young trial reports 40.4% of children aged 6 to under 12 left the obesity range on semaglutide, the first Phase 3 win in elementary-age obesity. #SyenzaNews #obesity #GLP1 #MarketAccess

Definium Therapeutics' DT120 ODT met its primary endpoint in the Phase 3 Panorama trial, delivering a 5.1-point placebo-adjusted improvement on the HAM-A anxiety scale. #SyenzaNews #GAD #MentalHealth #MarketAccess

The FDA's landmark hearing on psychedelic medicines drew 80 speakers and 1,800 registrants, and the market access message was clear: approval is not access, and reimbursement is the binding constraint. #SyenzaNews #MarketAccess #Psychedelics #HealthPolicy

Enhertu's DESTINY-Lung04 trial cut the risk of progression versus chemo-immunotherapy in first-line HER2-mutant NSCLC, but an immature overall-survival trend and a 20.8% ILD rate complicate the path to a first-line label. #SyenzaNews #Oncology #NSCLC #MarketAccess

NICE has opened consultation on draft guidance that does not recommend lenacapavir for HIV PrEP, finding the six-monthly injection is not value for money for the NHS in England. #SyenzaNews #HTA #HIV #PrEP #MarketAccess

Real-world UK data presented at ERS 2026 link semaglutide to fewer asthma attacks and COPD exacerbations. The indication stays metabolic, but the signal raises a real question for value and access teams. #SyenzaNews #MarketAccess #GLP1 #Respiratory