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Egetis Therapeutics — Investor Relations & Filings

Ticker · EGTX ISIN · SE0003815604 LEI · 549300RZCKGWRUBPMY22 ST Manufacturing
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Filings indexed 282 across all filing types
Latest filing 2022-02-17 Interim / Quarterly Rep…
Country SE Sweden
Listing ST EGTX

About Egetis Therapeutics

https://www.egetis.com/

Egetis Therapeutics is an innovative and integrated pharmaceutical company focused on developing and commercializing treatments for serious and rare diseases with significant unmet medical needs. The company's strategy centers on advancing drug candidates through late-stage clinical development to market approval. Its primary asset, Emcitate (tiratricol), is a first-in-class drug candidate in late-stage development for the treatment of Monocarboxylate Transporter 8 (MCT8) deficiency, a rare congenital disorder of thyroid hormone transport.

Recent filings

Filing Released Lang Actions
Interim / Quarterly Report 2021
Interim / Quarterly Report Classification · 95% confidence The document is a 'Year-end report' for the period January-December 2021. It contains comprehensive financial data (revenue, loss, cash flow, loss per share) for both the quarter and the full year, alongside detailed management commentary, CEO remarks, and R&D pipeline updates. It is not a short announcement (RPA) nor a standalone audit report, but a substantive interim/annual financial report. Given it covers the full fiscal year and provides detailed financial statements and analysis, it is classified as an Interim/Quarterly Report (IR) in the context of this taxonomy, as it serves the function of a periodic financial performance report. FY 2021
2022-02-17 English
Egetis concludes that demonstrating treatment effects on T3 levels in MCT8-deficiency could provide a basis for marketing approval for Emcitate® in the US
Regulatory Filings Classification · 100% confidence The document is titled 'PRESS RELEASE' and announces key regulatory interactions with the FDA regarding the path to marketing approval for a drug (Emcitate®) for a rare disease (MCT8-deficiency). It details the plan for an NDA submission in mid-2023, outlines a small verification study, and discusses ongoing clinical trials (Triac Trial II). This content is characteristic of a company providing timely, material updates to the market regarding its drug development pipeline and regulatory strategy. It is not a full Annual Report (10-K), a formal Audit Report (AR), a transcript (CT), or a formal dividend notice (DIV). Since it is a press release announcing significant business and regulatory progress, it fits best under the general category of a significant corporate announcement. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a material press release that doesn't fit a more specific category like ER or IR, although it strongly relates to regulatory progress. However, because it is a detailed announcement of strategy and clinical progress, it is more substantial than a simple 'Report Publication Announcement' (RPA). Since the core content is a strategic update on regulatory pathways and clinical data summaries, and it is explicitly labeled a 'PRESS RELEASE', it functions as a major corporate disclosure. In the absence of a specific 'Corporate Update' or 'Press Release' code, RNS (Regulatory Filings/Announcements) serves as the best fit for this type of material news release.
2022-01-18 English
Egetis drar slutsatsen att en behandlingseffekt på T3-nivåer hos patienter med MCT8-brist kan utgöra grund för marknadsgodkännande av Emcitate® i USA
Regulatory Filings Classification · 100% confidence The document is a press release dated January 18, 2022, from Egetis Therapeutics AB. It announces positive interactions with the FDA regarding the path to market approval (NDA submission planned for mid-2023) for their drug Emcitate® for MCT8 deficiency. It details the plan for a small, randomized, controlled study to verify T3 levels, discusses ongoing clinical trials (Triac Trial II), and mentions Orphan Drug Designation and Fast Track status. The text concludes with standard boilerplate information about the company and the disease. This content is a significant corporate update regarding regulatory strategy and clinical development milestones for a drug candidate, which aligns best with an 'Earnings Release' (ER) if it were quarterly results, but since it is a specific, material announcement about regulatory progress and future filings, it fits the description of a general corporate announcement. However, given the options, it is not a formal financial report (10-K, IR, MRQ), nor is it a transcript (CT) or a presentation (IP). It is a material announcement that is not explicitly covered by other codes like DIV, DIRS, or MANG. In the context of financial reporting, major announcements about regulatory progress and future filing timelines often fall under the umbrella of an Earnings Release (ER) which covers key operational and financial highlights, or sometimes as a general Regulatory Filing (RNS) if it were less detailed. Since this is a detailed press release announcing a major strategic step towards market approval and future filings (NDA), it functions as a key operational update. Given the choices, 'ER' (Earnings Release) is often used broadly for major periodic announcements, but 'RNS' (Regulatory Filings) is the best fit for a non-periodic, material regulatory/clinical update that doesn't fit the other specific categories, especially since the final paragraph mentions the information is being published under the EU Market Abuse Regulation.
2022-01-18 Swedish
Egetis planerar att lämna in ansökan om marknadsgodkännande för Emcitate® till den europeiska läkemedelsmyndigheten baserat på befintliga kliniska data
Regulatory Filings Classification · 100% confidence The document is a press release from Egetis Therapeutics dated December 13, 2021. The core content announces the company's plan to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for their drug Emcitate®, based on existing clinical data. It discusses regulatory interactions, clinical trial results (Triac Trial I and long-term data), and future timelines for the submission. This is not a full Annual Report (10-K), an Interim Report (IR), or a simple Earnings Release (ER). It is a specific announcement regarding regulatory strategy and clinical data supporting a future regulatory filing. Since it is a formal announcement detailing progress towards regulatory submission and includes scientific/clinical updates, it fits best as a general Regulatory Filing (RNS) or potentially an Investor Presentation (IP) if it were structured as slides, but given the press release format focusing on regulatory milestones, RNS is the most appropriate general category for significant, non-standardized regulatory updates that aren't explicitly covered by other codes like DIRS or DIV. However, because the content is a detailed announcement about the *results* of regulatory discussions and the *plan* for a major regulatory submission (MAA), it is a significant corporate update. Given the options, RNS (Regulatory Filings - general regulatory announcements and fallback) is suitable, but since it details the outcome of regulatory discussions leading to a major submission, it is a key piece of investor information. Since it is a detailed press release announcing a major regulatory step (MAA submission plan based on data), and not just a brief notice of publication (RPA), RNS is the best fit as a comprehensive regulatory/corporate update that doesn't fit ER, IR, or 10-K.
2021-12-13 Swedish
Egetis intends to submit a marketing authorisation application for Emcitate® to the European Medicines Agency based on existing clinical data
Regulatory Filings Classification · 100% confidence The document is a press release announcing the company's intention to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for their drug Emcitate®, based on existing clinical data. It details regulatory interactions (pre-submission meeting with EMA Rapporteur/Co-Rapporteur) and future timelines for submission. This type of announcement, which communicates a significant step in the regulatory or development process but is not the final regulatory filing itself, often falls under general corporate updates or investor communications. Since it discusses regulatory strategy and upcoming submissions, it is closely related to investor information. However, it is not a formal Earnings Release (ER), Interim Report (IR), or a specific legal/financing document. Given the focus on regulatory strategy and the nature of the announcement (a press release detailing a key development milestone), it best fits the general category of Investor Relations communication. Since there is no specific code for 'Regulatory Strategy Update' or 'Press Release', and it is not a formal report (10-K, IR), the most appropriate classification among the provided options is either 'RNS' (Regulatory Filings - general fallback) or 'IP' (Investor Presentation - if it were a presentation). Since it is a formal press release detailing strategic regulatory steps and clinical data sufficiency, it functions as a key piece of information for investors. Given the context of regulatory milestones, 'RNS' (Regulatory Filings) is a strong candidate as a general announcement, but 'IP' (Investor Presentation) is often used for detailed strategic updates shared with investors, even if delivered via press release. However, the content is a direct announcement of regulatory intent, which aligns well with the broad scope of 'RNS' if it doesn't fit elsewhere. Let's re-evaluate the definitions. It is not a formal report (10-K, IR), nor a management discussion (MDA), nor a specific transaction (DIV, POS). It is an announcement about regulatory progress. 'RNS' is the fallback for miscellaneous regulatory announcements. I will classify it as RNS as it is a general regulatory/corporate announcement that doesn't fit the more specific report types.
2021-12-13 English
Valberedning utsedd inför årsstämman 2022 i Egetis Therapeutics
Board/Management Information Classification · 99% confidence The document is a press release dated November 5, 2021, announcing the establishment of the Nomination Committee (Valberedning) for the upcoming Annual General Meeting (Årsstämman) in 2022. The text details the members appointed by the largest shareholders and outlines the committee's tasks, which include proposing board members, auditors, and remuneration for the AGM. This content directly relates to the preparation and governance surrounding the Annual General Meeting. While it is not the AGM presentation itself (AGM-R) or the proxy statement (DEF 14A/PSI), it is a specific announcement concerning the governance structure leading up to the AGM. Given the options, this type of preparatory governance announcement fits best under Governance Information (CGR) or potentially Regulatory Filings (RNS) if CGR is too broad. However, since it specifically deals with the composition of the body responsible for nominating directors for the AGM, it is fundamentally a corporate governance matter. Since there is no specific code for 'Nomination Committee Appointment,' CGR (Governance Information) is the most appropriate fit, as it covers internal rules and board structure preparation. It is not an ER, IR, or CT, and it is too specific for a general RNS.
2021-11-05 Swedish

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