Eli Lilly and Company announced groundbreaking positive topline results from the Phase 3 TRIUMPH-4 clinical trial, confirming its investigational triple-agonist drug, retatrutide, delivered unprecedented weight loss of up to 28.7% (71.2 lbs) and substantial relief from the pain and functional limitations associated with knee osteoarthritis.
Eli Lilly announced that its non-covalent BTK inhibitor, Jaypirca (pirtobrutinib), met the primary endpoint of non-inferiority on Overall Response Rate (ORR) when compared to Imbruvica (ibrutinib) in the landmark BRUIN CLL-314 Phase 3 trial. The drug demonstrated numerically higher efficacy (87.0% ORR) and a significant safety advantage, including much lower rates of atrial fibrillation/flutter and hypertension, positioning Jaypirca as a potential new front-line therapy for CLL/SLL.
Eli Lilly and Company is set to present “striking” new data at the 2025 ASH Annual Meeting, revealing a double victory for its BTK inhibitor, Jaypirca (pirtobrutinib). Results from two pivotal Phase 3 trials demonstrate that Jaypirca not only outperforms standard chemoimmunotherapy in first-line treatment but also meets non-inferiority benchmarks against the established drug ibrutinib. These findings could pave the way for Jaypirca to become a new standard of care for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) across multiple treatment settings.
Merck announced promising results from its pivotal Phase 3 CORALreef HeFH trial. The study found that enlicitide, an investigational, once-daily oral PCSK9 inhibitor, significantly reduced low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH). These late-breaking data were presented at the AHA Scientific Sessions 2025.
Gilead Sciences announced its Phase 3 ASCENT-07 trial for Trodelvy® in first-line HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS). However, the company reported an “early trend” favoring Trodelvy for the key secondary endpoint of overall survival (OS), and the study will continue to gather more data on this measure.
Roche’s Phase III ALLEGORY study for Gazyva® (obinutuzumab) in systemic lupus erythematosus (SLE) met its primary and all key secondary endpoints. These “unprecedented” results demonstrate Gazyva’s potential to effectively control disease activity and may delay or prevent further organ damage in people with SLE.
New 96-week data from the Phase 3 GALAXI and GRAVITI studies show high rates of sustained remission for TREMFYA® (guselkumab) in Crohn’s disease. At two years, over 86% of patients on maintenance doses achieved clinical remission, reinforcing its long-term efficacy as the only fully subcutaneous IL-23 inhibitor for the condition.
Eli Lilly and Company (NYSE: LLY) announced on Friday that it has reached a final agreement to purchase clinical-stage gene therapy startup Adverum Biotechnologies, Inc. [Read More…]
Positive data from GSK’s pivotal PIVOT-PO Phase III trial show that oral tebipenem HBr is a promising new treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The study, which was stopped early for efficacy, demonstrated that the oral antibiotic was non-inferior to the current standard of care, intravenous imipenem-cilastatin. These findings mark a significant step towards the first oral carbapenem for cUTIs, potentially changing the treatment landscape for patients and addressing the challenge of antimicrobial resistance.
Eli Lilly and Company announced major findings from the seven-year monarchE trial. Their CDK4/6 inhibitor, Verzenio® (abemaciclib), is the first in its class to demonstrate a statistically significant overall survival benefit for patients with HR+, HER2-, high-risk early breast cancer when added to endocrine therapy.
