Calliditas Therapeutics' Shares Gain Following Conditional Marketing Authorization From European Commission For Kidney Disease Candidate

The European Commission (EC) has granted conditional marketing authorization for Calliditas Therapeutics’s CALT Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN).

The regulatory approval is supported by the efficacy and safety data of Part A of the NeflgArd pivotal Phase 3 multicentre study conducted to investigate Kinpeygo 16 mg once daily oral dose vs placebo in adult patients with primary IgAN.

The company is expected to transfer the Marketing Authorization for Kinpeygo to its commercial partner STADA, who plans to launch Kinpeygo in the EEA in the second half of 2022.

Renée Aguiar-Lucander, CEO, said, "We are excited to receive the formal approval of Kinpeygo in the EEA as the first and only EMA approved medication for this disease. We look forward to continuing to work with our European partner, Stada, as they prepare for commercialization.”

This conditional marketing authorization applies in all 27 European Union Member States as well as Iceland, Norway and Liechtenstein.

Price Action : Calliditas Therapeutics shares are trading around 9 percent higher at $18.05 on Friday at the time of publication.