Vera shares skyrocket as kidney disease drug succeeds in late-stage trial

By Siddhi Mahatole

(Reuters) -Shares of Vera Therapeutics surged 60% on Monday after its experimental drug helped significantly reduce harmful levels of proteins in the urine of kidney disease patients in a late-stage study.

The drug developer is seeking to bring a self-administered injectable drug for patients with IgA nephropathy, also known as Berger’s disease, which causes abnormal protein buildup in the kidneys and could eventually lead to the organ’s failure.

Several companies, including Japan’s Otsuka Holdings and Novartis are racing to bring effective treatments for the disease. The market for those drugs could be worth as much as $10 billion in the U.S., two analysts have estimated.

Vera’s drug, atacicept, reduced protein levels in patients’ urine by 46%, compared with a 7% reduction with a placebo, meeting the main goal of the 428-patient study, the company said.

Investors were expecting a reduction of 35%, said Evercore ISI analyst Liisa Bayko in a note.

Vera’s shares were trading at $30.32, giving it a market value of $1.96 billion, if gains hold.

About 90% of patients in the trial adhered to the dosing regimen of the drug, Vera said, adding that it could give it an edge over its competition.

“To our knowledge, this is the only pivotal phase 3 trial in which at-home self-administration has been conducted. So our numbers reflect that type of administration, and I think that’s a very strong position to be in,” Vera CEO Marshall Fordyce told Reuters.

Otsuka has already filed for a U.S. Food and Drug Administration approval of its injectable drug, sibeprenlimab.

Sibeprenlimab is expected to reach the market six to nine months ahead of Vera’s atacicept, Bayko said.

Vera plans to submit its application for FDA’s accelerated approval in the fourth quarter and expects a U.S. commercial launch in mid-2026.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Leroy Leo)