Investor FAQs
The Company is incorporated in Stockholm, Sweden
Calliditas was first listed at Nasdaq Stockholm in 2018, and at Nasdaq US in 2020
The fiscal year ends Dec 31
The auditor is Ernst&Young AB
Read more on our Auditor page
Please see our SEC filing section
Please contact:
Marie Galay, IR Manager
Email: [email protected]
Telephone: +44 79 55 12 98 45
For more information about Calliditas’ commercial product, please visit www.tarpeyo.com
The product is only approved in the USA.
Calliditas is advancing its delayed release formulation of budesonide under the development name “NEFECON®” outside of the USA. Calliditas submitted a Marketing Authorisation Application for NEFECON to the European Medicines Agency in May 2021. If approved, the drug could be available to patients in the European Economic Area (EEA) member states, Switzerland and the UK in 2022.
Calliditas partnered with Everest Medicines to commercialise NEFECON® in Greater China and Singapore in 2019. In July 2021, Calliditas announced a partnership with STADA to commercialise NEFECON in the European Economic Area (EEA) member states, Switzerland and the UK.
Calliditas submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for NEFECON® in May 2021.
The NefIgArd trial is still ongoing, with the full data readout expected in early 2023. Calliditas is also conducting an open label extension trial with NEFECON®.
With its drug candidate setanaxib, a first-in-class NOX1/4 Inhibitor, Calliditas has initiated a Phase 2b/3 adaptive design trial in PBC and will initiate a Phase 2 study in head and neck cancer.