Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Wall Street promptly began trying to weigh the compound’s marketplace odds after Merck & Co. Inc. detailed positive data from the phase IIb/III trial known as MK-1654-004 with clesrovimab, an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, plus interim findings from the ongoing phase III experiment dubbed MK-1654-007 were offered during IDWeek 2024 in Los Angeles.
Paragon Therapeutics Inc. and Spyre Therapeutics Inc. jointly presented preclinical data for the novel extended half-life humanized anti-IL-23 monoclonal antibody (MAb), SPY-003, being developed for the treatment of inflammatory bowel disease (IBD).
Researchers from Xencor Inc. presented the discovery and preclinical characterization of XmAb-942, a novel high-affinity anti-TL1A monoclonal antibody (MAb) being developed for the treatment of inflammatory bowel disease (IBD).
China’s National Medical Products Administration has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, marking the third PCSK9 inhibitor to be cleared in China.
Recent advances in the management of inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, have shown that inhibiting the interaction between the α4β7 integrin and the endothelial ligand mucosal addressin cell adhesion molecule 1 (MADCAM1) has proven useful, safe and effective.
The U.S. FDA has approved the second hemophilia drug in nearly six months from Pfizer Inc. This one, Hympavzi (marstacimab), is for preventing or reducing bleeding in those age 12 and older with hemophilia A and B. Hympavzi heralds a couple of market boundary breakers: it’s the first and only anti-tissue factor pathway inhibitor approved in the U.S. for hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered using a pre-filled, auto-injector pen.
China’s National Medical Products Administration has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, marking the third PCSK9 inhibitor to be cleared in China.
Cytotoxic T-lymphocyte antigen 4 (CTLA-4) is a cell surface molecule with immunosuppressive function involved in T-cell immune regulation and proliferation. Researchers from Shanghai Junshi Biosciences Co. Ltd. and collaborators described the preclinical evaluation of JS-007, a humanized monoclonal antibody targeting CTLA-4, in cancer models.
Shares of Scholar Rock Holding Corp. (NASDAQ:SRRK) soared $26.86, or 362%, to close Oct. 7 at $34.28, after the Cambridge, Mass.-based firm disclosed positive top-line data from the phase III Sapphire study testing apitegromab in patients with spinal muscular atrophy (SMA). Apitegromab, which Wainwright analyst Andres Maldonado said will “transform SMA” therapy, met the primary endpoint with statistically significant and clinically meaningful improvement in motor function as measured by the Hammersmith Functional Motor Scale Expanded.
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