Our History – Calliditas Therapeutics AB

The company was founded in 2004 under the name Pharmalink AB and is based in Stockholm, Sweden.

Timeline

First patient enrolled in pivotal clinical phase 3 study NefIgArd with lead candidate Nefecon

Calliditas listed on Nasdaq Stockholm’s main list

Pharmalink changes name to Calliditas Therapeutics

Publication of results from Phase 2b study in The Lancet

End-of-Phase 2 meetings with FDA and EMA

Preparations for end-of-Phase 2 meetings with FDA and EMA

Obtains orphan designation for Nefecon in Europe

Publication of meta-analysis related to change in urine protein as a surrogate endpoint with regards to IgA nephropathy, Tufts Medical Center, 2016

Invited to work with the Kidney Health Initiative (American Society of Nephrology) to identify surrogate endpoints in IgA nephropathy

Receives financing from existing investors to progress clinical process towards Phase 3

Announces initial results from Phase 2b trial and achieves the primary endpoint in a planned interim analysis

Nefecon core patents are granted in the US, Europe, China and Hong Kong

Investinor joins the existing investors to finance the completion of the Phase 2b study

Owners including Industrifonden and Bengt Julander finance the launch of the Phase 2b (NEFIGAN) trial

The Phase 2a study is completed with positive results

Calliditas obtains orphan designation for Nefecon in the United States

Nefecon becomes the lead product candidate

Calliditas gains exclusive rights to the formulation technology to develop and manufacture Nefecon Stiftelsen

Industrifonden invests in the company