Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels.
A month away from the PDUFA decision date for a Leqembi (lecanemab) subcutaneous autoinjector to be used for maintenance dosing for those with early Alzheimer’s disease, Eisai Co. Ltd. and Biogen Inc. presented clinical data at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto, showing comparable efficacy and safety to the FDA-approved intravenous formulation.
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
Formation Bio Inc. has licensed worldwide rights to Imidomics Inc.’s potentially first-in-class anti-CD226 monoclonal antibody (mAb). The program has received IND clearance and will be advanced by Formation Bio in autoimmune indications, starting with ulcerative colitis.
Intracerebral hemorrhage accounts for 10%-15% of all cases of stroke, and it is associated with particularly poor prognosis due to primary and secondary brain injury driven by neuroinflammation. This inflammation involves the activation and subsequent pyroptosis, or lytic cell death, of microglia.
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
Nextcure Inc. has unveiled new preclinical data supporting the therapeutic potential of NC-605, a new anti-Siglec-15 antibody, in treating osteogenesis imperfecta, a rare genetic disorder characterized by fragile bones and frequent fractures.
Sino Biopharmaceutical Ltd. agreed to fully acquire Lanova Medicines Ltd. by buying an additional 95.09% stake in Lanova at a valuation of up to $950.92 million. Considering Lanova’s estimated cash and deposit of $450 million, Hong Kong-headquartered Sino agreed to pay $500.9 million to Lanova on the date of the transaction, set to close within 30 days of all conditions being satisfied, or July 31, 2025.
Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis.
The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance therapy in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
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