Vera Therapeutics, Inc. (NASDAQ:VERA) announced on January 7 that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Atacicept for priority review. The application seeks approval to treat adult patients with immunoglobulin A nephropathy (IgAN).
The submission was made under the Accelerated Approval Program. The FDA has set a target action date of July 7, 2026. If approved, the drug would allow patients to administer a weekly injection at home.
Marshall Fordyce, M.D., founder and CEO of Vera Therapeutics, stated that approval would enhance care for IgAN. He noted Atacicept would be the first B-cell modulator to simultaneously target both APRIL and BAFF.
Data from the ORIGIN 3 trial showed participants treated with Atacicept experienced a 46% decline in proteinuria from baseline at week 36. The urine protein-to-creatinine ratio was reduced by 42% compared to placebo.
Shares of Vera Therapeutics have returned nearly 53% over the past three months. As of January 12, Wall Street's average one-year price target is $74.08, projecting a further upside of 59.45%.
On January 7, Guggenheim and LifeSci Capital reiterated Buy ratings on the stock. Their price targets were $56 and $70, respectively.
Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for complex immunological diseases.