Vera's Trutakna generates $10.3m in third quarter as company seeks full US approval
Vera Therapeutics' first marketed product brought in $10.3m in net sales after its July launch, and the company has asked the FDA to move it from conditional to full approval.
Vera Therapeutics recorded net sales of $10.3m for Trutakna (atacicept-vymj) in the third quarter of 2026, according to results released on 5 November. It is the first revenue the company has earned from a marketed medicine.
The drug is approved in the US to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The FDA granted that clearance on 7 July under the accelerated pathway, so the quarterly figure reflects the months since launch. The company gave no further sales detail in the material available to us.
Two days before reporting, on 3 November, Vera sent the agency a supplemental biologics licence application seeking full approval. The submission draws on two-year results from the ORIGIN 3 study. Vera expects an FDA decision in mid-2027.
Vera also plans to apply to the European Medicines Agency for marketing authorisation in the first quarter of 2027. No European timetable beyond that filing has been disclosed.
By way of context, accelerated approval lets a drug reach patients on the strength of a surrogate marker, such as lower proteinuria. Continued marketing normally depends on later evidence of clinical benefit, which is what a conversion to full approval would formalise.
Why it matters
- Trutakna's $10.3m is the first measure of commercial uptake for Vera's only marketed product, and later quarters will show how demand develops.
- The mid-2027 FDA decision is the next regulatory milestone, and it would convert the current conditional US label to full approval.
- A European application in early 2027 would open a second major market, but the filing alone does not set an approval or launch date.
Company's press release (SEC filing): Vera Therapeutics, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.