Stockholm, Sweden

Calliditas partner STADA

receives positive CHMP opinion recommending full approval for Kinpeygo for the treatment of IgA nephropathy

Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Committee for Medicinal Products

for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation

for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).

Kinpeygo, which was granted

conditional marketing authorisation in EU on 15 July 2022, was the first ever approved treatment for IgAN in the EU and UK. The full

approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation

of > 1.5g/g to encompassing the entire study population, defined as UPCR of 0.8g/g, or proteinuria of 1.0 g/g over 24 hours.

Kinpeygo is marketed in in the EU and UK exclusively by Calliditas' commercial partner, STADA Arzneimittel AG.

"This is an important

day for patients suffering from IgAN in Europe as Kinpeygo represents the first ever fully approved medication for this rare kidney disease.

The long-term confirmatory trial met its eGFR endpoint with high statistical significance and we are delighted that EMA now has issued

a positive opinion," said Renee Aguiar-Lucander, CEO.

opinion will now be forwarded to the European Commission (EC), which has the authority to grant this full marketing authorisation for

Kinpeygo in the European Union (EU) member states, and which will be adopted by Iceland, Norway and Liechtenstein. A final decision by

the EC on granting a marketing authorisation is anticipated in August 2024.

For further information,

sa Hillsten, Head of

IR & Sustainability, Calliditas

Tel.: +46 76 403 35 43, Email:

the report is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent

for publication, through the agency of the contact person set out above, on May 30, 2024, at 8:00 p.m. CET.

Calliditas Therapeutics

is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in

orphan indications with significant unmet medical needs. Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX)

and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit Calliditas.com for further information.

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