ICAHN School of Medicine At Mount Sinai

FDA approved Celltrion's Stelara biosimilar Steqeyma for psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Steqeyma, a fully human monoclonal antibody, showed no clinical or safety differences from ustekinumab in a phase 3 study. It will be available in subcutaneous and intravenous formulations in 2025. Other Stelara biosimilars have also been approved.

The FDA approved Celltrion’s Steqeyma, a biosimilar to Stelara, for treating plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Steqeyma, an IL-12 and IL-23 antagonist, is available in SC and IV formulations. The approval reflects Celltrion’s commitment to expanding treatment options for chronic inflammatory diseases affecting millions in the US.

The FDA approved Celltrion's Steqeyma, a biosimilar to Stelara, for psoriatic conditions and IBD. Steqeyma is the seventh biosimilar for Stelara, joining Celltrion's immunology portfolio. It is available in subcutaneous and intravenous forms and is supported by phase III study data showing similarity to Stelara in safety and efficacy.

Ustekinumab-stba (Steqeyma; Celltrion) received FDA approval for treating plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis in adults and pediatric patients. It selectively inhibits IL-12 and IL-23, available as subcutaneous injection or intravenous infusion, launching in Feb 2025.

The FDA approved Celltrion's Steqeyma as the seventh Stelara biosimilar for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, with a launch expected in February 2025.

Researchers at Icahn School of Medicine identified lurbinectedin's mechanism, activating STING-IFN signaling to boost immune response against small-cell lung cancer, enhancing PD-L1 blockade therapy efficacy.

The FDA approved Celltrion's CT-P43/ustekinumab-stba (Steqeyma), an ustekinumab biosimilar, for plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Based on phase III evidence, Steqeyma demonstrated high similarity to ustekinumab in efficacy and safety, with expected launch in February 2025.

FDA approved STEQEYMA based on phase III study results showing high similarity to ustekinumab in safety and efficacy for moderate to severe plaque psoriasis. STEQEYMA is indicated for multiple immune-mediated diseases and joins Celltrion's immunology portfolio.

MediWound Ltd. will host a virtual KOL event on Jan 8, 2025, discussing EscharEx®, a biologic drug in late-stage development for chronic wound debridement, including the Phase III VALUE study in venous leg ulcers and its commercial potential. The event features clinical experts John C. Lantis II, Vickie R. Driver, and Robert J. Snyder, discussing EscharEx's Phase II results, upcoming Phase III study, unmet needs in wound care, and competitive advantages.

Navtemadlin monotherapy showed safety and efficacy in relapsed/refractory myelofibrosis patients, with a 3-fold increase in spleen volume reduction (SVR35) and 2-fold increase in total symptom score reductions (TSS50) compared to best available therapy (BAT) in the BOREAS study. Treatment-emergent adverse effects were mostly grade 1 and 2, reversible, and predictable in onset and resolution. The POIESIS study will evaluate navtemadlin in sub-optimal responders.