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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 2019-12-19 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
Completion of recruitment of Part A of the NeflgArd pivotal Phase 3 clinical trial by year end
Regulatory Filings Classification · 95% confidence The document is a press release dated December 19, 2019, announcing the completion of recruitment for Part A of the NefIgArd pivotal Phase 3 clinical trial. It details progress, regulatory interactions (FDA, EMA), expected timelines for results (Q4 2020), and includes quotes from the CEO. This type of announcement, focusing on operational milestones and clinical trial updates, is typically classified as a general regulatory announcement or news release, as it does not fit the specific definitions for Earnings Release (ER), Interim Report (IR), or a formal Audit Report (AR). Since it is a specific operational update that doesn't fit the other specialized categories (like M&A, Capital, or Management changes), the most appropriate general category is Regulatory Filings (RNS), which serves as a fallback for miscellaneous regulatory announcements not covered elsewhere. The document length (4768 chars) is substantial enough that it is the primary announcement itself, not just a notice of a report being published (which would suggest RPA).
2019-12-19 English
Rekryteringen till del A av den registreringsgrundande fas 3-studien NefIgArd slutförs vid årets slut
Regulatory Filings Classification · 95% confidence The document is a press release from Calliditas Therapeutics AB announcing a clinical trial milestone (completion of enrollment for Part A of the NefIgArd Phase 3 study) and providing updates on regulatory interactions (FDA, EMA) and expected data readout timelines (Q4 2020). It also mentions the company's intention to file for market approval in H1 2021. This content is characteristic of an announcement detailing operational progress, often released outside of mandatory periodic financial filings. Since it is not a full financial report (10-K or IR), a transcript (CT), or a specific management/board change, it fits best as a general regulatory announcement or an update that doesn't fit other specific categories. Given the context of clinical trial progress and regulatory updates, it is most closely aligned with a general regulatory announcement, which falls under RNS, or potentially an Earnings Release (ER) if it were tied to a quarterly report, but here it seems standalone. Since it is a specific operational update that doesn't fit the other specialized codes (like DIV, CAP, MANG, DIRS), RNS (Regulatory Filings - general/miscellaneous) is the most appropriate fallback, although it shares characteristics with an ER if it were a summary of operational highlights. Given the focus on trial progress rather than financial results summary, RNS is chosen as the best fit for a non-financial, operational update.
2019-12-19 Swedish
China IND approval triggers $5 million milestone payment from Everest Medicines
Regulatory Filings Classification · 100% confidence The document is a press release dated December 17, 2019, announcing a specific corporate event: a milestone payment triggered by a partner (Everest Medicines) receiving IND approval from the NMPA for a drug candidate (Nefecon). This type of announcement, detailing progress in drug development, licensing agreements, and associated financial triggers (milestone payments), is characteristic of corporate news releases related to financing, partnerships, or clinical progress. It is not a formal regulatory filing like a 10-K, an earnings release (ER), or a comprehensive quarterly report (IR). Since it details a specific financial/development trigger related to a licensing agreement, it fits best under Capital/Financing Update (CAP) or potentially Regulatory Filings (RNS) if no other category fits. Given the focus on the \$5 million milestone payment triggered by regulatory approval, CAP is the most appropriate specific category for financing/capital structure changes resulting from development milestones. It is too specific for the general RNS fallback.
2019-12-17 English
IND-godkännande i Kina framkallar 5 miljoner dollar i milstolpsbetalning från Everest Medicines
Regulatory Filings Classification · 100% confidence The document is a press release from Calliditas Therapeutics announcing that their partner, Everest Medicines, received IND approval from the Chinese NMPA for the drug Nefecon, triggering a $5 million milestone payment. The text explicitly states, "Denna information är sådan som Calliditas Therapeutics AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning." This language strongly indicates a mandatory regulatory disclosure intended for immediate public dissemination, often categorized as a general regulatory announcement or a specific announcement related to financing/corporate events. Since the core content is an announcement about a partnership milestone payment and regulatory progress, it fits best under a general regulatory filing category, as it is not a full financial report (10-K, IR), an earnings release (ER), or a specific management/board change (MANG). Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a time-sensitive, mandatory disclosure that doesn't fit a more specific operational or financial report category. The document length (4371 chars) is short enough to suggest it is an announcement rather than a comprehensive report.
2019-12-17 Swedish
Krassimir Mitchev steps up as acting CMO
Board/Management Information Classification · 99% confidence The document explicitly announces a change in senior management: 'Krassimir Mitchev steps up as acting CMO' and details the departure of the previous CMO. This directly aligns with the definition of Board/Management Information (MANG), which covers announcements of changes in senior management.
2019-11-14 English
Calliditas utser Krassimir Mitchev som tillförordnad CMO
Board/Management Information Classification · 99% confidence The document text is a press release announcing a change in senior management: Dr. Krassimir Mitchev is taking over as interim Chief Medical Officer (CMO) from Dr. Jens Kristensen. This directly corresponds to the definition of 'Board/Management Information' (MANG), which covers announcements of changes in senior management.
2019-11-14 Swedish

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