STOCKHOLM (dpa-AFX) - Calliditas Therapeutics AB (CALT) said that the U.S.
Food and Drug Administration has approved TARPEYO or budesonide delayed release
capsules to reduce the loss of kidney function in adults with primary
immunoglobulin A nephropathy or IgAN at risk for disease progression.

CALT closed Wednesday's regular trading at $22.48 up $1.44 or 6.84%. In the
after-hours trading, the stock further gained $5.95 or 26.47%.

TARPEYO was first approved in December 2021 under accelerated approval, based on
the surrogate marker of proteinuria.

TARPEYO is now the first fully FDA-approved treatment for IgAN based on a
measure of kidney function, Calliditas said.

The approval is based on data from the company's Phase 3 NefIgArd clinical
trial, a randomized, double-blind, multicenter, study that assessed the efficacy
and safety of TARPEYO dosed at 16 mg once daily versus placebo on a background
of optimized RASi therapy in adult patients with primary IgAN.

According to the company, TARPEYO is available exclusively through Calliditas
specialty pharmacy, Biologics by McKesson.

For More Such Health News, visit rttnews.com.



Copyright(c) 2023 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX