Eli Lilly Announces Positive Results from Two Phase 3 Studies of Jaypirca at ASH 2025

Eli Lilly and Company

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 48-Week Data Shows TREMFYA® (guselkumab) Substantially Inhibits Joint Damage in Psoriatic Arthritis

JohnsonAndJohnson

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.

Roche’s Fenebrutinib Shows “Unprecedented” Phase III Success in Both Relapsing and Progressive Multiple Sclerosis

Roche

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’s Oral PCSK9 Inhibitor, Enlicitide, Shows Significant LDL-C Reduction in Phase 3 CORALreef HeFH Trial

Merck MSD

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’s Trodelvy Misses Primary Goal in First-Line Breast Cancer Study, But Hope Remains for Overall Survival

Gilead

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’s Eloralintide Shows Up to 20.1% Weight Loss in Phase 2 Obesity Study

Eli Lilly and Company

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.

Roche Announces Positive Phase III ALLEGORY Study Results for Gazyva®/Gazyvaro® in Systemic Lupus Erythematosus

Roche

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.

TREMFYA® (guselkumab) Demonstrates Durable Two-Year Remission in Crohn’s Disease, New Phase 3 Data Show

JohnsonAndJohnson

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.