Stockholm, Sweden

announces extended orphan drug exclusivity period for TARPEYO in U.S.

Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the FDA has granted a new orphan

drug exclusivity period of seven years for TARPEYO , starting from Dec 20, 2023, when the company obtained full approval

with a new indication. Orphan drug exclusivity for TARPEYO will now run through December 20, 2030.

21 CFR 316.31(b), orphan drug exclusivity is intended to protect "the approved indication or use of a designated drug." Following

full approval, TARPEYO is now indicated "to reduce the loss of kidney function in adults with primary immunoglobulin

A nephropathy (IgAN) who are at risk for disease progression". This indication is different from the original accelerated approval

indication both because it covers a broader range of patients with IgAN, and because it is based on a confirmed clinical benefit on kidney

function for patients with IgAN, whereas the original indication was to reduce proteinuria related to their kidney disease.

are delighted to have another two years of market exclusivity for TARPEYO in the US, reflecting the revised indication

based on the long-term data generated ," said CEO Ren e Aguiar-Lucander.

further information, please contact:

Hillsten, Head of IR & Sustainability, Calliditas

+46 76 403 35 43, Email: asa.hillsten@calliditas.com

information in the press release 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 persons set out above, on March 6, 2024 at 08:00 a.m. CET.

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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