AstraZeneca Etcamah SERENA-4 Trial Misses Primary Endpoint in First-Line Breast Cancer Study
AstraZeneca’s Phase III SERENA-4 trial of Etcamah (camizestrant) plus palbociclib missed statistical significance for progression-free survival in first-line advanced ER-positive breast cancer, though a numerical benefit was observed. The company says the miss sharpens its focus on ESR1-mutation-driven use of Etcamah under its existing SERENA-6 approval, with safety unchanged from each medicine’s known profile.
Kyowa Kirin KHK4951 Eye Drops Report Phase 2 nAMD Data as Primary Endpoint Is Missed
Kyowa Kirin KHK4951 eye drops missed their Phase 2 primary endpoint in neovascular age-related macular degeneration, though most patients maintained vision through Week 52 with no new safety signals in Study 4951-002.
Roche Enspryng MOGAD Filing Wins FDA Priority Review as First Potential Treatment for Rare Neuroimmune Disease
The FDA has granted Priority Review to Roche’s Enspryng (satralizumab) for MOGAD, a rare autoimmune CNS disease with no approved treatments, after Phase III METEOROID data showed a 68% relapse risk reduction.
Charles River Endosafe Cartridge Manufacturing Goes Fully Automated at Massachusetts Facility
Charles River Laboratories has completed automation of its Endosafe Cartridge Technology manufacturing suite in Wilmington, Massachusetts, reporting double-digit gains in productivity, capacity and product consistency ahead of full operational scale-up in Q3 2026.
Amgen: IMDELLTRA Imfinzi Combination Delivers Landmark Survival Gain in DeLLphi-305 Trial
Amgen’s Phase 3 DeLLphi-305 trial shows the IMDELLTRA Imfinzi combination delivers a statistically significant, clinically meaningful overall survival benefit as first-line maintenance therapy in extensive-stage small cell lung cancer, alongside gains in progression-free survival and response rate.
Semaglutide Childhood Obesity Trial Meets Primary Endpoint as Novo Nordisk’s STEP Young Study Shows 40.4% of Children No Longer Classified as Having Obesity
Novo Nordisk’s phase 3 STEP Young trial found that 40.4% of children aged 6 to under 12 treated with once-weekly semaglutide were no longer classified as having obesity after 68 weeks, versus none on placebo — a first efficacy readout for semaglutide in this young age group.
Novartis Pelacarsen Lp(a)HORIZON Trial Results: Phase III Study Misses Primary Cardiovascular Endpoint
Novartis announced pelacarsen Lp(a)HORIZON trial results on September 4, 2026, revealing that the Phase III cardiovascular outcomes study did not meet its primary endpoint, even though the investigational therapy lowered Lp(a) levels in more than 8,300 patients with established cardiovascular disease.
IQVIA Predictive Clinical Development Cuts Trial Delays With AI-Powered Approach
IQVIA has launched IQVIA Predictive Clinical Development, an AI-powered platform built with Anthropic, AWS, Databricks, Microsoft, NVIDIA, Palantir and Snowflake, designed to help sponsors bring new therapies to market up to two years faster.
AstraZeneca Secures Etcamah Breast Cancer Approval in Combination With CDK4/6 Inhibitors for US Patients
AstraZeneca’s Etcamah (camizestrant) has won US FDA approval alongside CDK4/6 inhibitors for HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation before disease progression.
AbbVie’s Etentamig Multiple Myeloma Trial Meets Both Primary Endpoints in Phase 3 CERVINO Study
AbbVie’s Phase 3 CERVINO trial shows etentamig, an investigational BCMA x CD3 bispecific, significantly improved response rate and progression-free survival versus standard therapies in relapsed/refractory multiple myeloma.