William Blair on Vera Therapeutics (VERA): 'We believe this update has positive read-through to companies developing novel therapies for IgAN'
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William Blair analyst Matt Phipps reiterated an Outperform rating and {REMOVEPT} price target on Vera Therapeutics (NASDAQ: VERA)
The analyst comments "On Tuesday, June 2, Vera Therapeutics (VERA $32.09) announced that it had aligned with the FDA on an updated analysis plan for the Phase III ORIGIN 3 study of the APRIL/BAFF inhibitor atacicept in IgA nephropathy (IgAN). Originally, the typical two-year analysis of estimated glomerular filtration rate (eGFR) required to support full approval was expected to be completed in 2027, but Vera has aligned with the FDA on an earlier eGFR analysis, enabling a readout in the third quarter of 2026. Although Vera did not announce the specific time point for the earlier eGFR analysis, we assume it is a one-year analysis based on enrollment timelines (ORIGIN 3 completed enrollment in April 2025). Vera has a PDUFA date in July 2026 for accelerated approval of atacicept in IgAN based on interim proteinuria data. With the third quarter 2026 eGFR data, Vera plans to file for full approval in the fourth quarter of 2026. The change was supported by feedback following a recent workshop hosted by the National Kidney Foundation (NKF), where study design for modern IgAN clinical trials was discussed with study sponsors, regulators, and clinicians. While typical studies in IgAN have assessed eGFR at year two, shorter studies are likely more appropriate in the current treatment landscape, particularly considering the ethics of long-term placebo treatment for IgAN patients given the availability of treatment options that have the potential to stabilize kidney function and prevent permanent nephron loss. We believe this update has positive read-through to companies developing novel therapies for IgAN, including APRIL±BAFF-targeting therapies in development by Jade Biosciences, Climb Bio, and Vertex in our coverage, enabling potentially shorter registrational studies and accelerating time to full approval."
For an analyst ratings summary and ratings history on Vera Therapeutics click here. For more ratings news on Vera Therapeutics click here.
Shares of Vera Therapeutics closed at $33.94 yesterday.
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