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.
Novartis AG’s financial update included good news about Scemblix (asciminib), the first and only U.S. FDA-approved allosteric inhibitor for chronic myeloid leukemia (CML), which gained clearance in October 2021. The drug introduced a new mechanism of action by specifically targeting the ABL myristoyl pocket.
Following a priority review, Apellis Pharmaceuticals Inc. received U.S. FDA approval of a supplemental NDA making pegcetacoplan the second marketed treatment for complement 3 glomerulopathy and the first for primary immune complex membranoproliferative glomerulonephritis.
Matchpoint Therapeutics Inc. and Novartis AG have entered into an exclusive option and license agreement to develop and commercialize oral covalent inhibitors targeting a transcription factor linked to a number of inflammatory diseases. Matchpoint’s approach leverages the properties of covalent chemistry and a proprietary platform to target a novel binding site on a historically hard-to-drug protein.
Novartis AG has disclosed huntingtin (HTT; HD) (mutant) splicing modulators reported to be useful for the treatment of familial dysautonomia, Huntington’s disease and spinal muscular atrophy.
In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The PCSK9 inhibitor is looking to fit into a crowded market that already has well-established therapies from other big pharmas and a potential competitor in development to treat another indication.
More phase III data coursed through the annual American Society of Clinical Oncology (ASCO) conference on Sunday, as Protagonist Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. led the charge with positive results for its potential blockbuster rusfertide in treating a rare leukemia.
More phase III data coursed through the annual American Society of Clinical Oncology (ASCO) conference on Sunday, as Protagonist Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. led the charge with positive results for its potential blockbuster rusfertide in treating a rare leukemia.
Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of mortality worldwide despite advances in managing classic risk factors and therapies lowering LDL-cholesterol. Inhibiting angiopoietin-like protein 4 (ANGPTL4), a key regulator of triglyceride metabolism, is emerging as a potential strategy to treat atherogenic dyslipidemia and lower ASCVD risk.
A former board member of Chinook Therapeutics Inc. and four others were charged May 22 in a 19-count indictment stemming from an alleged insider trading scheme that produced more than $600,000 in profits after the June 2023 announcement that Novartis AG was acquiring the Seattle-based Chinook in a $3.5 billion deal.