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Calliditas Therapeutics — Investor Relations & Filings

Ticker · CALTX ISIN · SE0010441584 LEI · 549300PVPZO8TNT76B58 ST Manufacturing
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Filings indexed 282 across all filing types
Latest filing 2021-07-16 Capital/Financing Update
Country SE Sweden
Listing ST CALTX

About Calliditas Therapeutics

https://www.calliditas.se/en/

Calliditas Therapeutics is a commercial-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for rare diseases with significant unmet medical needs. The company concentrates on orphan indications, with an initial focus on renal and hepatic diseases. Its lead product, TARPEYO® (budesonide), is approved in the U.S. for the treatment of primary immunoglobulin A nephropathy (IgAN) and is marketed as Kinpeygo® in Europe. Calliditas is advancing a pipeline of novel medications and seeks strategic partnerships to expand its development and commercialization efforts for therapies addressing conditions with few or no existing approved treatments.

Recent filings

Filing Released Lang Actions
Calliditas secures $75 million term loan facility
Capital/Financing Update Classification · 99% confidence The document is a press release dated July 15, 2021, announcing that Calliditas Therapeutics has secured a \$75 million term loan facility from Kreos Capital. This announcement details financing activities, loan tranches, interest rates, and the intended use of proceeds (product launch support and clinical development). This content directly aligns with the definition of 'Capital/Financing Update'. Therefore, the appropriate filing type code is CAP.
2021-07-16 English
Calliditas Announces Submission of Marketing Authorisation Application for Nefecon to the European Medicines Agency
Regulatory Filings Classification · 95% confidence The document is a press release dated May 28, 2021, announcing that Calliditas Therapeutics has submitted a Marketing Authorisation Application (MAA) for its drug Nefecon to the European Medicines Agency (EMA). This announcement details clinical trial results (NefIgArd Phase 3) that support the submission and discusses the expected review timeline and potential approval. This type of announcement, focusing on regulatory submission milestones and clinical data updates, is characteristic of an Investor Presentation (IP) or a general press release related to corporate development. Since it is a detailed announcement of a major regulatory step and includes extensive background on the drug and trials, it aligns best with an Investor Presentation (IP) which often accompanies or precedes such major news, or it could be classified as a general Regulatory Filing announcement if it were shorter. Given the length and detail, it functions as a comprehensive update for investors about a key development milestone. However, none of the definitions perfectly capture a 'Regulatory Submission Announcement' outside of the general 'RNS'. Comparing the options, it is not an ER (only highlights), not an IR (not a comprehensive financial report), and not an RPA (it is the news itself, not an announcement *about* a report). It contains significant strategic and clinical detail aimed at investors. In the context of the provided definitions, an Investor Presentation (IP) often covers such strategic and clinical progress updates. If it were purely a regulatory filing notice, RNS would apply, but this is a detailed narrative. Given the focus on the MAA submission and supporting data, it is most closely related to the information shared in an Investor Presentation (IP) or a detailed press release that functions as one. I will classify it as IP due to the depth of clinical and strategic information provided, which is typical for investor briefings, even though it is structured as a press release.
2021-05-28 English
Calliditas har lämnat in ansökan om marknadsgodkännande (Marketing Authorisation Application) för Nefecon till EMA
Regulatory Filings Classification · 95% confidence The document is a press release dated May 28, 2021, announcing that Calliditas Therapeutics has submitted a Marketing Authorisation Application (MAA) for its drug Nefecon to the European Medicines Agency (EMA). The text details the basis of the application (Phase 3 study data), the regulatory pathway (Accelerated Assessment), and future expectations regarding approval and commercialization. This type of announcement, detailing significant regulatory milestones (like filing for approval) and providing context on clinical data, is characteristic of an Earnings Release (ER) or a general press release related to corporate/pipeline progress. Since it focuses on the immediate announcement of a major regulatory submission and includes key financial/pipeline updates, it aligns best with the 'Earnings Release' (ER) category, which often encompasses major operational news outside of specific financial statements or dedicated investor presentations. It is not a full Annual Report (10-K), a specific Audit Report (AR), or a mere announcement of a report publication (RPA). Given the context of a major pipeline update coinciding with a regulatory filing, ER is the most appropriate fit among the provided options for a significant corporate announcement.
2021-05-28 Swedish
Kommuniké från årsstämman i Calliditas Therapeutics AB (publ)
AGM Information Classification · 99% confidence The document is titled "Kommuniké från årsstämman i Calliditas Therapeutics AB (publ)" which translates to "Communiqué from the Annual General Meeting (AGM) in Calliditas Therapeutics AB (publ)". The text details decisions made during the meeting held on May 27, 2021, including the approval of financial statements, board/auditor elections, remuneration, incentive programs, and amendments to the articles of association. These contents are characteristic of the outcomes and resolutions passed at an Annual General Meeting. Therefore, the appropriate classification is AGM-R (AGM Information).
2021-05-27 Swedish
Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ)
AGM Information Classification · 100% confidence The document explicitly states it is a "Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ)" and details the resolutions passed regarding the adoption of financial statements, election of board members, approval of remuneration, and adoption of incentive programs. This content directly corresponds to the outcomes and minutes of an Annual General Meeting (AGM). Therefore, the appropriate classification is AGM-R.
2021-05-27 English
Interim / Quarterly Report 2021
Interim / Quarterly Report Classification · 100% confidence The document is a 'Delårsrapport' (Interim Report) for Calliditas Therapeutics AB covering the period 1 January to 31 March 2021. It contains comprehensive financial data, including income statements, balance sheet items (liquidity), and detailed management commentary on clinical trials, regulatory filings (FDA/EMA), and business operations. It is a substantive financial report for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report. Q1 2021
2021-05-18 Swedish

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