JANSSEN BIOTECH, INC.

Janssen-Cilag International NV submitted a Type II variation application to the EMA for IMBRUVICA® (ibrutinib) in combination with R-CHOP for previously untreated mantle cell lymphoma (MCL) patients eligible for autologous stem cell transplant. Supported by the TRIANGLE study, ibrutinib-based regimens showed improved efficacy over standard care, offering a potential alternative to transplant.

Janssen-Cilag announces TECVAYLI® (teclistamab) data from MajesTEC-5 and MajesTEC-4 studies, showing 100% MRD negativity in newly diagnosed multiple myeloma patients, presented at 2024 ASH Annual Meeting.

Johnson & Johnson announces TECVAYLI® (teclistamab-cqyv) data showing 100% MRD negativity in newly diagnosed multiple myeloma patients treated with MajesTEC-5 induction and MajesTEC-4 maintenance therapies, presented at the 2024 ASH Annual Meeting.

DARZALEX FASPRO significantly delayed progression from high-risk SMM to active MM and extended overall survival in Phase 3 AQUILA study, presented at 2024 ASH Annual Meeting.

EchoGo® Amyloidosis, an AI-powered tool, aids in detecting Cardiac Amyloidosis with 84.5% sensitivity and 89.7% specificity, supported by Janssen and Pfizer. Early detection is crucial for therapeutic benefits, addressing diagnostic challenges in underdiagnosed conditions.

Icotrokinra (JNJ-2113) met co-primary endpoints in moderate to severe plaque psoriasis, with 74% achieving clear or almost clear skin at week 24. Results to be presented at medical congresses.

Johnson & Johnson announced positive Phase 3 results for icotrokinra (JNJ-2113), showing significant skin clearance and tolerability in moderate to severe plaque psoriasis patients. Icotrokinra, a once-daily oral peptide targeting the IL-23 receptor, met co-primary endpoints of PASI 90 and IGA 0/1 at week 16, with response rates improving through week 24. Safety data aligned with previous studies, and further Phase 3 trials are ongoing.

Johnson & Johnson submits regulatory applications to FDA and EMA for DARZALEX FASPRO and DARZALEX SC for high-risk smoldering multiple myeloma, supported by Phase 3 AQUILA study data, aiming to shift treatment paradigm.