Intellia's lonvo-z is on a priority-review track to March 10, 2027 with no advisory committee planned. The one-dose gene edit cut HAE attacks 87% in Phase 3, and the debate over permanence, competition, and price will happen largely out of view.
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KRAS sat on the undruggable list for decades. Silexion's SIL204 is built to silence the mutation earlier in the cell, and the Phase 2/3 program is now moving into patients.
BigHat Biosciences raised $75 million as BHB810, a CDH17 VHH-Fc ADC, entered a Phase 1/2 gastric cancer trial. The round tests whether wet-lab data can fix AI drug discovery's translation problem.
FDA cleared lirafugratinib (Lyrfigtu) for FGFR2-altered cholangiocarcinoma after ReFocus posted a 46% response rate. The clinical argument is FGFR1 sparing. The cost is months of mandatory retinal monitoring.