The RNAi pioneer voluntarily suspended dosing of the hemophilia candidate to consider trial protocol alterations after a patient receiving fitusiran in an open-label, Phase II trial died following a thrombosis event.
Less than a year after shuttering its amyloidosis candidate revusiran due to patient deaths in a Phase III trial, Alnylam Pharmaceuticals Inc. announced another setback Sept. 7, saying it was temporarily suspending dosing in ongoing studies of its hemophilia candidate fitusiran because of a patient death in a Phase II trial.
Alnylam said it hopes to restart dosing of fitusiran within three to six months by amending safety protocols in ongoing...
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US FDA approval of Niktimvo for third-line chronic GVHD, a competitor to Sanofi’s Rezurock, came less than two months ahead of anticipated approval of Syndax’s leukemia drug revumenib.
The company’s giroctocogene fitelparvovec, partnered with Sangamo, could compete with BioMarin’s hemophilia A gene therapy Roctavian, but longer-term data may be needed.
2seventy bio sold full rights to a hemophilia A program and in vivo gene editing technology to partner Novo Nordisk.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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