GSK plc (LSE/NYSE: GSK) today announced positive results from its pivotal Phase III clinical trial program for bepirovirsen. This investigational treatment could redefine the standard [Read More…]
Gilead has announced positive Phase 3 results for its investigational single-tablet regimen (STR) of bictegravir and lenacapavir (BIC/LEN) in the ARTISTRY-2 trial. The new combination met its primary endpoint, demonstrating non-inferiority to BIKTARVY in maintaining viral suppression in adults with HIV-1. This novel two-drug regimen combines the potent integrase inhibitor bictegravir with the first-in-class capsid inhibitor lenacapavir, representing a potential new, simplified treatment option for long-term HIV management.
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.
New long-term data from the Phase 3b APEX study confirms that TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to substantially inhibit the progression of structural joint damage in patients with active psoriatic arthritis, with results sustained through 48 weeks.
Dr. Jogin Desai presents Eyecyte-RPE™ data at Innoxbio CGT 2025 in China, showing a 14.8-letter average gain in visual acuity and a strong safety profile.
Roche announced today that its investigational oral medication, fenebrutinib, has met primary endpoints in two separate, pivotal Phase III studies for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The drug significantly reduced relapse rates in RMS and slowed disability progression in PPMS, positioning it as a potential first-in-class, high-efficacy oral treatment for the two most common forms of the disease.
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.
Eli Lilly and Company announced positive Phase 2 trial results for eloralintide, its investigational once-weekly, selective amylin receptor agonist. The study met its primary endpoint, showing that adults with obesity or overweight achieved mean weight reductions of up to 20.1% over 48 weeks, compared to 0.4% with placebo. The drug also demonstrated a favorable tolerability profile, with mild-to-moderate gastrointestinal symptoms being the most common adverse events. Lilly plans to advance eloralintide to Phase 3 trials by the end of 2025.
