Innovative Medicine

CAPLYTA® nearly doubled the likelihood of remission at six weeks compared to placebo as an adjunctive therapy to an antidepressant based on pooled data from two Phase 3 studies 65% of patients reached remission with CAPLYTA®, with 43% achieving sustained relief from symptoms, in a six-month open-label extension safety study Newly approved as an adjunctive for major depressive disorder, CAPLYTA® supports the ultimate treatment goal of remission with robust short-term data and long-term open-label safety data

TECVAYLI® alone reduced risk of disease progression or death by 71% in a high unmet need population MajesTEC-9 is the second positive Phase 3 study to support TECVAYLI® regimens as a potential new standard of care as early as first relapse

New CAPLYTA® (lumateperone) Phase 3 analyses evaluating efficacy in achieving remission in adjunctive major depressive disorder (aMDD) to be presented SPRAVATO® (esketamine) effects on anhedonia in treatment-resistant depression (TRD) – Phase 3 data post-hoc analyses to be presented Comparative tolerability of adjunctive seltorexant vs. adjunctive quetiapine XR in major depressive disorder (MDD) with insomnia symptoms – new Phase 3 metabolic analyses will also be presented

Over 70 percent of patients in the first-line subgroup responded to amivantamab plus chemotherapy with most responses lasting beyond 16 months Notable responses were also seen in patients with liver metastases, who often face poorer outcomes with this disease

Tony Hunter, Ph.D., celebrated for pioneering discoveries that inspired the development of more than 80 cancer therapies that continue to transform patient lives

Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as second-line1 The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement in progression-free and overall survival compared to standard treatment1

The JASMINE study met the primary endpoint and key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing SLE is one of the most prevalent and debilitating autoantibody diseases, causing one’s own immune system to mistakenly attack various tissues, which can lead to potentially life-threatening systemic organ damage Based on these positive topline results, the company plans to initiate a Phase 3 program for nipocalimab in SLE

RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions1-5 Approval builds on previously reported Phase 3 MARIPOSA data showing unmatched overall survival benefit of this chemotherapy-free regimen, projected to exceed four years6

Expanded indication for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone marks the first FDA-approved precision medicine combination treatment for patients with BRCA2-mutated mCSPC