Citius Pharmaceuticals Inc. gained the U.S. FDA’s go-ahead for Lymphir (denileukin diftitox), a new immunotherapy for relapsed/refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug is Cranford, N.J.-based Citius’ first approved therapy and the only CTCL treatment that targets the interleukin-2 receptor found on malignant T-cells and regulatory T cells. It’s also the first green light given the FDA for r/r CTCL since 2018. Shares of Cranford, N.J.-based Citius (NASDAQ:CTXR) were trading at 83 cents, down 7 cents.
Yes, IGaN: Novartis’ proteinuria therapy receives FDA approval
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The treatment already had an approval. In December 2023, the oral factor B inhibitor of alternative complement pathway became the first oral monotherapy for adults with the rare blood disease paroxysmal nocturnal hemoglobinuria. In January, Sanreno Therapeutics, of Shanghai, was acquired by Novartis for an undisclosed amount. Through the acquisition, Novartis gained access to atrasentan, an oral endothelin A receptor antagonist, and zigakibart, a subcutaneously administered anti-APRIL antibody. Both are in clinical trials for treating IgAN.
Novo chops three drug studies at cardiometabolic intersection
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. While the firm has advanced ziltevekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients, Novo said it has terminated development of an unnamed vascular adhesion protein-1 inhibitor in a phase I study for metabolic dysfunction-associated steatohepatitis. The company also ended study of an unnamed once-monthly subcutaneous dual GLP-1/GIP receptor agonist for diabetes in May.
Luye advances dual agonist for schizophrenia, Alzheimer’s
China’s National Medical Products Administration has cleared Luye Pharma Group Ltd.’s new schizophrenia candidate LY-03020 to enter phase I trials in China. Independently developed by Shanghai-based Luye, the new chemical entity is a dual agonist that targets both the trace amine-associated receptor 1 and the 5-HT2C receptor and is intended to treat schizophrenia and Alzheimer’s disease psychosis.
Parasite could deliver therapeutic proteins to the brain
Infection or cure? Scientists from Tel Aviv University and the University of Glasgow genetically modified the Toxoplasma gondii to bring a protein inside neurons. The novelty of using a protozoan that can travel from the gut to parasitize the CNS contrasts with the possibility of causing a disease. The scientists are already working on how to avoid it.
Also in the news
Aeterna Zentaris, Ardelyx, Corvus, Exelixis, Eyenovia, Formosa, G1, Geovax, Idrx, Kyowa Kirin, Logix, Nammi, Neurogene, Newbridge, Novo Nordisk, Ocular Therapeutix, Pharmacosmos, Poxel, Precigen, Servier, Stoke, Sumitomo, Takeda, Voyager