Vera Therapeutics Aligns With FDA on Earlier Atacicept Analysis to Support Potential Full Approval

MT Newswires Live00:32

Vera Therapeutics (VERA) said Tuesday it aligned with the US Food and Drug Administration on a revised analysis plan for its phase 3 Origin trial of atacicept in adults with IgA nephropathy.

The biotechnology company said estimated glomerular filtration rate results from the trial are now expected in Q3. Pending those results, Vera plans to submit a supplemental biologics license application for full approval in Q4.

Vera said the FDA alignment was supported by phase 2b Origin trial results showing significant reductions in proteinuria, stabilization of kidney function and a placebo-comparable safety profile, while its phase 3 Origin trial met its primary endpoint and remains ongoing to evaluate eGFR changes.

Atacicept has received FDA Breakthrough Therapy Designation for IgAN, and Vera is also studying the drug in other kidney diseases, with enrollment completed in a separate dose-ranging study, the company said.

Shares of Vera Therapeutics were down more than 6% in Tuesday trading.

Price: 31.76, Change: -2.18, Percent Change: -6.42

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