Can J&J’s lumateperone raise the bar for MDD remission? New CAPLYTA data fuels fresh hope

Can J&J’s lumateperone raise the bar for MDD remission? New CAPLYTA data fuels fresh hope

Johnson & Johnson (J&J) has presented new pooled data from Phase 3 clinical trials showing that CAPLYTA (lumateperone), used as an adjunctive therapy with antidepressants, significantly improved remission rates in adults with major depressive disorder compared to placebo. The results, highlighted at the 64th Annual Meeting of the American College of Neuropsychopharmacology, indicate nearly double […]

J&J’s amivantamab shows strong first-line response in metastatic colorectal cancer

J&J’s amivantamab shows strong first-line response in metastatic colorectal cancer

Johnson & Johnson (J&J) has reported updated results from its Phase 1b/2 OrigAMI-1 trial evaluating amivantamab-vmjw in combination with chemotherapy for patients with RAS/BRAF wild-type metastatic colorectal cancer. The bispecific antibody, which targets epidermal growth factor receptor (EGFR) and MET, achieved confirmed response rates of 73 percent in the first-line setting and 44 percent in […]

J&J ends JNJ-5939 trial early in atopic dermatitis after missing efficacy mark

J&J ends JNJ-5939 trial early in atopic dermatitis after missing efficacy mark

Johnson & Johnson (J&J) announced that its investigational candidate JNJ-95475939 (JNJ-5939) failed to meet prespecified efficacy criteria in the DUPLEX-AD Phase 2b trial for moderate to severe atopic dermatitis. Following an interim analysis, the study was terminated early. Despite showing a favorable tolerability profile, the molecule did not demonstrate sufficient clinical efficacy to warrant continuation. […]

FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics […]

FDA approval gives J&J’s AKEEGA a first-mover edge in BRCA2-mutated metastatic prostate cancer

FDA approval gives J&J’s AKEEGA a first-mover edge in BRCA2-mutated metastatic prostate cancer

Johnson & Johnson (J&J) announced on December 12, 2025, that the U.S. Food and Drug Administration approved AKEEGA, a dual-action tablet combining niraparib and abiraterone acetate, alongside prednisone, for treating BRCA2-mutated metastatic castration-sensitive prostate cancer. The regulatory nod, based on the pivotal AMPLITUDE trial, makes AKEEGA the first precision medicine combination approved for this high-risk […]