Vera rises on early kidney function data in FDA review
VERA•Analysts point to supportive but still limited data
Jefferies said, "We view this as reassuring and supportive of the view that atacicept's (Trutakna) long-term eGFR profile could ultimately track closely to Otsuka's 4578.T sibeprenlimab."
The FDA said preliminary eGFR data appeared "promising," but the available evidence was insufficient to support traditional approval because data beyond Week 36 were limited.
The FDA added that data from the ongoing study is adequately powered and clinical benefit is "highly likely" to be verified.
Guggenheim said, "We remain bullish on VERA given the value we expect the company to create as it launches Trutakna into the large and growing IgAN market."
Including session moves, the stock is down 15.2% year to date.
FDA review documents show early kidney function data
Shares of Vera Therapeutics VERA.O rose 10.4% to $31.89.
The U.S. FDA published its review documents supporting the accelerated approval of Vera's drug, Trutakna, for patients with immunoglobulin A nephropathy.
The documents included an early look at estimated glomerular filtration rate (eGFR), a measure of kidney function, ahead of a late-stage data readout expected in Q3 2026.
