Vera Therapeutics shares rose 4.4 percent on Wednesday. The gain came after the company shared positive news from the U.S. drug regulator.
The FDA has accepted Vera’s application for its drug atacicept. The drug is being reviewed for the treatment of adults with IgA nephropathy. This is a serious kidney disease.
The FDA granted the application Priority Review. This means the agency will review the drug faster than usual. The target decision date has been set for July 7, 2026.
The application was filed under the Accelerated Approval Program. If approved, atacicept would be the first drug of its kind for this condition. It targets two key disease pathways known as BAFF and APRIL.
The drug could also be easier for patients to use. Vera says it may be given as a once weekly injection. Patients would be able to inject it at home using an autoinjector.
The FDA decision is based on results from the ORIGIN 3 clinical trial. In the study, atacicept reduced protein levels in urine by 46 percent from the starting point. This was much better than the placebo group.
Compared to placebo, the reduction was 42 percent. The result was considered highly meaningful from a scientific standpoint.
Vera’s CEO Marshall Fordyce said the drug takes a different approach than current treatments. He said the company believes it could improve care for patients if approved.
The FDA has already given atacicept Breakthrough Therapy status. This is reserved for treatments that may work better than existing options.
IgA nephropathy is a serious autoimmune disease. It can lead to kidney failure in at least half of patients over time.
The trial data was shared at a major kidney conference. It was also published in the New England Journal of Medicine in November.
The ORIGIN 3 study is still ongoing. Researchers are continuing to track kidney function over a two year period. Final results are expected in 2027.