Vertex Pharmaceuticals' Strategic Acquisition and FDA Breakthrough Designation Boosts Buy RatingWe note that Filspari (full approval), Fabhalta, Vanrafia are already approved for IgAN, indicating the FDA views data from the Phase II RUBY-3 clinical trial, which was used as the basis for granting BTD, as meaningfully differentiated from available therapies. We believe there is a case to be made that the FDA sees B-cell modulators as a class to fulfill an unmet need in IgAN despite Filspari full approval, given BTD is also held by Vera’s (VERA $27.44) atacicept and Otsuka’s (OTSKY $26.66) sibeprenlimab. For IgAN, once monthly subcutaneous 80 mg pove is currently under investigation in the Phase III RAINIER study, which has a prespecified interim analysis (IA) evaluating the urine- protein-to-creatinine ratio (UPCR) after a specified number of participants reach 36 weeks of treatment.