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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 2021-03-15 Regulatory Filings
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 lämnar in ansökan till FDA för behandling med Nefecon för patienter med primär IgA-nefropati
Regulatory Filings Classification · 95% confidence The document is a press release announcing that Calliditas Therapeutics has submitted a New Drug Application (NDA) to the FDA for their drug Nefecon for the treatment of primary IgA nephropathy (IgAN). It details the basis of the application (Phase 3 NefIgArd study results), discusses the regulatory pathway (accelerated approval), and provides company background. This type of announcement, focusing on a significant regulatory submission milestone for a drug candidate, is best classified as a general regulatory announcement or a specific type of corporate update. Since it is not a full financial report (10-K, IR), an earnings release (ER), or a management discussion (MDA), and it is a formal announcement of a regulatory action, it fits best under the general 'Regulatory Filings' (RNS) category, as it is a specific regulatory event announcement that doesn't align with the other specialized codes like DIV, CAP, or MANG. It is not a Report Publication Announcement (RPA) because it is announcing the *submission* of an application, not the publication of a previously mentioned report.
2021-03-15 Swedish
Calliditas Announces Submission of New Drug Application to U.S. FDA for Nefecon in Patients with Primary IgA Nephropathy
Earnings Release Classification · 95% confidence The document is a press release dated March 15, 2021, announcing that Calliditas Therapeutics has submitted a New Drug Application (NDA) to the U.S. FDA for their drug Nefecon. It details the clinical trial data (NefIgArd Phase 3) supporting the submission and discusses future commercialization plans. This type of announcement, detailing significant regulatory milestones (like an NDA submission) and providing substantial business/clinical updates, is characteristic of an Earnings Release (ER) or a general press release covering key operational news. Since it focuses on the submission and the underlying data rather than being a formal quarterly financial report (IR) or a transcript (CT), and it is not a specific regulatory filing like a 10-K, the most appropriate classification is Earnings Release (ER), as these often accompany or precede formal financial reporting periods with major operational news. It is not a Report Publication Announcement (RPA) because it is a detailed announcement of an event (submission), not just a notice that a report is available. FY 2021
2021-03-15 English
Major Shareholding Notification 2021
Major Shareholding Notification Classification · 99% confidence The document details a change in shareholding for Linc AB in Calliditas Therapeutics AB. It explicitly shows the 'Before the transaction' and 'After the transaction' share quantities and voting rights percentages, including the date of the transaction (05/03/2021) and the reason ('Reason for major shareholding notification Buy'). This structure perfectly matches the definition of a Major Shareholding Notification, which reports when ownership crosses specific thresholds. The corresponding code is MRQ.
2021-03-08 English
Earnings Release 2020
Earnings Release Classification · 99% confidence The document is titled "Bokslutskommuniké 1 januari – 31 december 2020" (Year-end Report January 1 – December 31, 2020) and contains detailed financial summaries for the fourth quarter and the full year 2020, including net sales, operating results, net profit, and earnings per share. It also includes a CEO's statement and an operational overview related to drug development (Nefecon). This structure—a comprehensive summary of annual financial performance accompanied by management commentary—is characteristic of an Annual Report or a closely related year-end financial disclosure. Since the document provides the full year's financial results and extensive operational details, it aligns best with the definition of an Annual Report (10-K), although it is presented in a Swedish format ('Bokslutskommuniké'). Given the comprehensive nature covering the entire fiscal year's performance, 10-K is the most appropriate classification among the provided options for a full-year financial report. FY 2020
2021-02-18 Swedish
Interim / Quarterly Report 2020
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Year-End Report January 1 – December 31, 2020' for Calliditas Therapeutics AB. It contains comprehensive financial data, including net sales, operating loss, loss per share, and cash positions for both the quarter and the full year. It also includes a CEO statement, business overview, and details on clinical trials. This meets the criteria for an Interim/Quarterly Report (IR) as it provides substantive financial statements and analysis for a specific period. FY 2020
2021-02-18 English
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 (Handelsbanken Fonder AB) in the issuer (Calliditas Therapeutics AB). It explicitly shows the 'Before the transaction' and 'After the transaction' share counts and voting rights, crossing a threshold (5%). This type of filing, reporting changes in significant share ownership, directly corresponds to the Major Shareholding Notification category. The code for this is MRQ.
2021-02-04 English

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