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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 2024-05-15 AGM Information
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
Kallelse till årsstämma i Calliditas Therapeutics AB (publ)
AGM Information Classification · 100% confidence The document is titled "Kallelse till årsstämma i Calliditas Therapeutics AB (publ)" which translates to "Notice of Annual General Meeting in Calliditas Therapeutics AB (publ)". The text details the date, time, location, registration procedures (including proxy voting and advance voting), the proposed agenda items (which include election of directors, approval of remuneration, and authorization for share issues), and proposals from the Nomination Committee. These elements are characteristic of a formal notice calling shareholders to an Annual General Meeting (AGM). Therefore, the correct classification is AGM Information (AGM-R).
2024-05-15 Swedish
Calliditas announces positive topline results of Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib
Earnings Release Classification · 95% confidence The document is a press release dated May 6, 2024, announcing positive topline results from a Phase 2 clinical trial for the drug setanaxib in head and neck cancer. It details statistical improvements in PFS and OS, quotes management and investigators, and outlines future clinical trial timelines (PBC, IPF, Alport syndrome). This content structure—announcing key clinical data and business updates via a press release—is characteristic of an Earnings Release (ER) or a general announcement. Since it focuses specifically on the release of new, material clinical data rather than a comprehensive quarterly financial report (IR) or a general regulatory filing (RNS), the most appropriate classification is Earnings Release (ER), as clinical trial results often drive investor interest and are frequently released concurrently with or near earnings periods, or as significant standalone news items. It is not a 10-K (Annual Report), IR (Interim Report), or CT (Call Transcript). It is not an RPA because it contains the substantive data, not just an announcement that a report is available. FY 2024
2024-05-06 English
Calliditas tillkännager positiva topline-resultat från fas 2-studien i huvud- och halscancer med den ledande NOX-hämmarkandidaten setanaxib
Earnings Release Classification · 99% confidence The document is dated May 6, 2024, and is titled with a headline announcing positive topline results from a Phase 2 study for the drug setanaxib in head and neck cancer. It details clinical data (PFS, OS improvements), quotes key personnel (CEO, CMO, investigator), and mentions future data readouts (Q3 2024, Q4 2024). The text concludes with a standard disclaimer regarding forward-looking statements and a note that the information is being made public under the EU Market Abuse Regulation. This structure—a concise announcement of key financial/operational results (clinical trial success) accompanied by forward-looking statements and regulatory disclosure language—is characteristic of an Earnings Release (ER) or a press release announcing significant operational milestones, which often overlaps with ER content, especially for biotech/pharma companies. Since it is the initial announcement of results, 'Earnings Release (ER)' is the most appropriate classification, as it communicates the core financial/operational performance update for the period/trial. FY 2024
2024-05-06 Swedish
Annual Report (ESEF) 2023
Annual Report (ESEF) Classification · 100% confidence FY 2023
2024-04-24 Swedish
Calliditas announces an additional seven year orphan drug exclusivity period for TARPEYO®
Earnings Release Classification · 99% confidence The document is a press release dated March 6, 2024, announcing that Calliditas has received an additional seven-year orphan drug exclusivity period for its drug TARPEYO® from the FDA. This announcement concerns a specific regulatory/intellectual property event related to a drug product, which is a type of corporate update. It is not a full financial report (10-K, IR), a management discussion (MDA), or a transcript (CT). While it relates to regulatory action, it is a specific announcement rather than a general regulatory filing fallback (RNS). The closest fit among the provided options for a specific, non-financial corporate event announcement that doesn't fit other categories is often classified under general regulatory or corporate news. Given the options, this is a specific corporate announcement regarding intellectual property/regulatory status. Since there is no specific code for 'Regulatory Approval/Exclusivity Announcement', and it is not a financial report, management discussion, or shareholder communication, it falls best under the general 'Regulatory Filings' (RNS) as a significant, non-financial, mandatory disclosure, or potentially 'LTR' if viewed as a legal/IP matter, but RNS is the standard fallback for press releases detailing regulatory milestones. Given the nature of the announcement (FDA decision), RNS is the most appropriate general regulatory disclosure category. Q1 2024
2024-03-06 English
Calliditas får ytterligare sju års marknadsexklusivitet för TARPEYO®
Regulatory Filings Classification · 95% confidence The document is a press release from Calliditas Therapeutics announcing that the FDA granted seven years of market exclusivity for their drug TARPEYO until December 2030. It details the basis for this exclusivity (new indication, clinical benefit) and includes standard sections like contact information, a statement about EU Market Abuse Regulation disclosure obligations, company boilerplate, and forward-looking statements. This type of announcement, which communicates a significant regulatory or business development outside of routine financial reporting (like 10-K or IR), fits best under the general 'Regulatory Filings' (RNS) category, as it is a formal public disclosure mandated by regulations, but does not match the specific definitions for ER, CT, CAP, or LTR. Given its nature as a formal, mandated public announcement, RNS is the most appropriate general regulatory disclosure category.
2024-03-06 Swedish

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