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Formycon AG — Investor Relations & Filings

Ticker · FYB ISIN · DE000A1EWVY8 LEI · 39120005TZ76GQOY8Z19 F Manufacturing
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Filings indexed 363 across all filing types
Latest filing 2024-09-30 Regulatory Filings
Country DE Germany
Listing F FYB

About Formycon AG

https://www.formycon.com/en/

Formycon AG is an independent, globally operating biopharmaceutical company specializing in the development of high-quality biosimilars. As a pure-play biosimilar developer, the company focuses on creating follow-on products for complex biopharmaceutical medicines after their patent protection has expired. The core mission is to enhance patient access to safe, effective, and affordable biologic therapies. Formycon's development activities are concentrated in therapeutic areas with high medical need, including ophthalmology and immunology. The company manages the entire development process, from analytics and process development to clinical trials and regulatory approval submissions for its biosimilar candidates.

Recent filings

Filing Released Lang Actions
Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)
Regulatory Filings Classification · 100% confidence The document is a press release dated September 30, 2024, announcing that Formycon and Fresenius Kabi received FDA approval for their biosimilar FYB202/OtulfiTM. The text focuses on a specific regulatory event (FDA approval) and its commercial implications, rather than being a comprehensive periodic financial report (like 10-K or IR) or a transcript. Since it is a specific, material announcement disseminated via a news service (EQS-News) concerning a regulatory milestone, it fits best under the general 'Regulatory Filings' category (RNS) as it is a formal regulatory update that isn't covered by the more specific financial report codes (like ER, AR, or IR). It is not a proxy statement (DEF 14A), an earnings release (ER), or a management discussion (MDA). Given the nature of the announcement (FDA approval), RNS is the most appropriate general regulatory announcement category.
2024-09-30 English
FDA grants approval for Stelara Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)
Regulatory Filings Classification · 100% confidence The document is an 'Ad-hoc' announcement dated September 27, 2024, disclosing 'inside information' according to Article 17 MAR. The core content is the announcement that the FDA granted approval for a biosimilar drug (FYB202/OtulfiTM). This is a specific, material corporate event announcement that is not a full financial report (like 10-K or IR), a management discussion (MDA), or a standard earnings release (ER). Since it is a mandatory disclosure of material, non-public information transmitted via a news service (EQS), and it doesn't fit the specific categories like Director's Dealing (DIRS), Capital Change (CAP), or Dividend (DIV), the most appropriate general category for significant, non-standard regulatory disclosures that are not explicitly defined elsewhere is Regulatory Filings (RNS). The document length is short (4460 chars) and it is a direct announcement, not a report itself.
2024-09-27 English
Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi (ustekinumab) for the treatment of serious inflammatory diseases
Regulatory Filings Classification · 100% confidence The document is a press release dated September 27, 2024, announcing that Formycon and Fresenius Kabi received European Commission approval for their biosimilar FYB202/Otulfi®. It details the regulatory event (EC approval following a positive CHMP opinion) and its implications for treating inflammatory diseases. This type of announcement, focusing on a specific regulatory milestone (approval) but not being a comprehensive financial report (like 10-K or IR), fits best under the general category for regulatory news or announcements that don't fit other specific financial reporting codes. Since it is a specific regulatory/product update, it is not a general Regulatory Filing (RNS) unless no other category fits. It is not an Earnings Release (ER), Interim Report (IR), or a formal Audit Report (AR). Given the content is a major regulatory approval announcement, it is most closely aligned with a general regulatory announcement, but since it is a specific, positive regulatory event announcement, it is often classified as a Regulatory Filing (RNS) if a more specific code like 'Approval Announcement' isn't available. However, looking at the definitions, 'RNS' is the fallback for miscellaneous filings. This is a specific regulatory event announcement. Since there is no specific 'Regulatory Approval' code, and it is not a financial report, 'RNS' (Regulatory Filings / General regulatory announcements) is the most appropriate fallback, as it is a formal announcement disseminated via EQS News.
2024-09-27 English
Half-yearly financial statements 2024
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Half-Year Report 2024' for Formycon Group. It contains a table of contents listing 'Interim Financial Statements', 'Interim Management Report', and 'Condensed Interim Statement of Financial Position'. It provides substantive financial data, management commentary, and operational updates for the first six months of the fiscal year. This fits the definition of an Interim/Quarterly Report (IR). H1 2024
2024-09-27 English
Formycon reports a strong first half-year with multiple milestones achieved
Earnings Release Classification · 100% confidence The document explicitly states: "Formycon AG (FSE: FYB, “Formycon“) today published its consolidated financial report for the first six months of fiscal year 2024, providing an update on the company’s business performance." It contains detailed financial figures (revenue, EBITDA) and operational updates for the 'first half-year' (H1/2024). This content structure—a comprehensive financial review for a period shorter than a year—is characteristic of an Interim/Quarterly Report. Although it mentions the full report can be found elsewhere, the text provided *is* the summary/release of those results, which aligns best with the 'Interim / Quarterly Report' definition (IR), rather than just a 'Report Publication Announcement' (RPA), given its substantial length and detailed financial content (20,841 chars). The keyword 'Half Year Report' further confirms this classification. H1 2024
2024-08-13 English
Half-yearly financial statements 2024
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Half-Year Report 2024' for Formycon Group. It contains a table of contents listing 'Interim Financial Statements', 'Interim Management Report', and 'Condensed Interim Statement of Financial Position'. It provides detailed financial performance data, business updates, and management commentary for the first half of the fiscal year. This fits the definition of an Interim/Quarterly Report (IR). H1 2024
2024-08-13 English

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