Picture1

2021

Calliditas announced full enrolment of the Phase 3 NefIgArd trial

Calliditas submitted a New Drug Application to the U.S. FDA and a Marketing Authorisation Application to the European Medicines Agency for patients with Primary IgA Nephropathy

Calliditas secured a $75 million term loan facility from Kreos Capital

Calliditas partnered with STADA Arzneimittel AG to register and commercialize a specialty therapy for IgA Nephropathy in Europe

Calliditas resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of approximately SEK 324 million

Calliditas completed its acquisition of Genkyotex, which became a wholly owned subsidiary of Calliditas and was delisted from the Euronext stock exchanges

On December 15 2021, the FDA granted Calliditas accelerated approval of TARPEYO™ (budesonide) to reduce proteinuria in IgA Nephropathy. TARPEYO became the first and only approved treatment for this indication

2020

Calliditas was listed on the Nasdaq Global Select Market, raising approximately USD 96,890,000

Calliditas acquired a controlling interest in Genkyotex SA

Calliditas announced positive topline results from the pivotal Phase 3 NefIgArd trial

2019

The pivotal Phase 3 clinical trial NefIgArd Part A was fully recruited

Calliditas and Everest Medicines entered into a license agreement to develop and commercialize Calliditas’ leading product candidate in Greater China and Singapore.

Calliditas exclusively in-licensed Budenofalk 3 mg oral capsules for the US market from the German pharmaceutical company, Dr. Falk Pharma GmbH.

Calliditas establishes a US presence

2018

The first patient was enrolled in the pivotal clinical Phase 3 study NefIgArd

Calliditas was listed on Nasdaq Stockholm’s main list, raising approximately SEK 739 million

2017

Pharmalink changed its name to Calliditas Therapeutics

The Phase 2b NEFIGAN study results were published in The Lancet

The company had end-of-Phase 2 meetings with the FDA and EMA

2016

The company prepared for end-of-Phase 2 meetings with the FDA and EMA

Pharmalink obtained orphan drug designation from the EMA for lead product candidate in Europe

A meta-analysis was published by the Tufts Medical Center

2015

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

The company received financing from existing investors to progress the clinical process towards Phase 3

Pharmalink announced positive initial results from the Phase 2b NEFIGAN trial, which achieved its primary endpoint in a planned interim analysis

2014

Core patents for lead product candidate were granted in the US, Europe, China and Hong Kong

2013

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

2012

Owners, including Industrifonden and Bengt Julander, financed the launch of the pivotal Phase 2b NEFIGAN trial

calliditas-our-history-2011-image

2011

Pharmalink gained exclusive rights to the formulation technology, TARGIT®, for developing and manufacturing lead product candidate under a 2011 agreement with Archimedes Development Ltd

2010

Pharmalink obtained orphan drug designation from the FDA for lead product candidate in the United States

2009

The Phase 2a study with lead product candidate was completed with positive results

2008

Identified the company’s lead product candidate

2004

Calliditas was founded as a public limited company under the laws of Sweden on February 20, 2004 under the name Pharmalink AB and was registered with the Swedish Companies Registration Office on April 15, 2004.