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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 2021-09-14 Legal Proceedings Report
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
Förlängt PDUFA måldatum för Nefecon i USA
Legal Proceedings Report Classification · 99% confidence The document is a press release from Calliditas Therapeutics announcing that the FDA has extended the PDUFA target date for their NDA for Nefecon to December 15, 2021, due to the submission of additional analyses. This type of announcement, which communicates a specific regulatory event (PDUFA date extension related to a drug application) and is issued as a formal press release, typically falls under general regulatory announcements or earnings/financial updates. Since it is not a full Annual Report (10-K), a comprehensive Interim Report (IR), or a specific management discussion (MDA), and it is not explicitly an Earnings Release (ER) which usually focuses on financial figures, the most appropriate category is a general Regulatory Filing (RNS) or potentially a Capital/Financing Update (CAP) if the drug approval was central to financing, but RNS is the best fit for general regulatory news updates that don't fit elsewhere. However, reviewing the definitions, this is a specific announcement about a regulatory process milestone (PDUFA date extension). It is not a Call Transcript (CT), Director's Dealing (DIRS), or Dividend Notice (DIV). It is a regulatory update. Given the options, RNS (Regulatory Filings - general fallback) is suitable, but let's check if it fits better elsewhere. It is not an Earnings Release (ER) as it focuses on regulatory status, not financial results. It is not a Legal Proceedings Report (LTR). Since it is a formal announcement of a regulatory action/milestone, RNS is the most appropriate general category for non-standard regulatory news.
2021-09-14 Swedish
PDUFA goal date extension for Nefecon NDA in the U.S.
Regulatory Filings Classification · 95% confidence The document is a press release announcing that the FDA has extended the PDUFA goal date for Calliditas Therapeutics' New Drug Application (NDA) for Nefecon. This announcement concerns regulatory interaction and the timeline for a potential drug approval, which is a specific type of corporate update. It is not a full Annual Report (10-K), an Earnings Release (ER), a Call Transcript (CT), or a formal Audit Report (AR). Since it details a specific regulatory event (FDA review timeline change) that doesn't fit neatly into the other specific categories like M&A (TAR) or Capital Changes (CAP), it falls best under the general category for regulatory announcements that aren't standard SEC forms or earnings reports. Given the options, 'Regulatory Filings' (RNS) serves as the most appropriate fallback for significant, non-standard regulatory news, although it is closely related to the drug development process. However, since the core content is a specific announcement about a regulatory process milestone, and not a general filing announcement (RPA), RNS is the best fit among the provided codes for this type of corporate news release.
2021-09-14 English
Number of shares and votes in Calliditas Therapeutics
Declaration of Voting Results & Voting Rights Announcements Classification · 99% confidence The document explicitly discusses an increase in the number of shares and votes due to a 'directed share issue' on August 12, 2021, resulting in a new total share count as of August 31, 2021. This directly relates to a change in the company's capital structure via the issuance of new shares. This aligns perfectly with the definition for 'Share Issue/Capital Change' (Code: SHA). The document is short and appears to be a formal announcement regarding this specific capital event.
2021-08-31 English
Antal aktier och röster i Calliditas Therapeutics
Declaration of Voting Results & Voting Rights Announcements Classification · 99% confidence The document explicitly states that the number of shares and votes in Calliditas Therapeutics AB has increased due to a directed share issue completed on August 12, 2021, resulting in a new total of 52,341,584 shares as of August 31, 2021. This content directly relates to a change in the company's capital structure (share issuance). This aligns perfectly with the definition of 'Share Issue/Capital Change' (SHA). It is not a general regulatory filing (RNS) because it is highly specific to a capital event, nor is it a Director's Dealing (DIRS) or a general financing update (CAP), but specifically about the resulting share count.
2021-08-31 Swedish
Declaration of Voting Results & Voting Rights Announcements 2021
Declaration of Voting Results & Voting Rights Announcements Classification · 99% confidence The document details a change in shareholding percentage by a specific holder ('Fjärde AP-fonden') in the issuer ('Calliditas Therapeutics AB'). It explicitly shows the 'Before the transaction' and 'After the transaction' share quantities and the resulting percentage, crossing a threshold (implied by the structure, as it mentions a 5% limit). This type of filing, reporting changes in significant share ownership, corresponds directly to the Major Shareholding Notification category.
2021-08-26 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 30 June 2021. It contains detailed financial statements, including income statements, balance sheet summaries, and management commentary (VD-ord) regarding operational performance, clinical trials (NefIgArd), and regulatory status. It is a comprehensive financial report for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report. H1 2021
2021-08-19 Swedish

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