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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 2025-01-15 Legal Proceedings Report
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 announce MHRA approval for FYB202/Otulfi (ustekinumab), a biosimilar to Stelara
Legal Proceedings Report Classification · 99% confidence The document is a press release dated January 15, 2025, announcing that Formycon and Fresenius Kabi received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for their biosimilar drug FYB202/Otulfi®. This announcement details a specific regulatory event (drug approval) and is distributed via EQS News, which often carries regulatory or corporate news. Since it is an announcement about a regulatory action (approval) rather than a comprehensive financial report (10-K, IR) or a general shareholder vote result, it fits best under the general 'Regulatory Filings' category (RNS) as a specific regulatory update, or potentially as a general announcement. Given the options, RNS serves as the best fit for a specific, non-financial regulatory milestone announcement that isn't a formal SEC filing like 10-K or a specific report like AR or SR. It is not an Earnings Release (ER), Interim Report (IR), or a proxy statement (PSI). It is a specific regulatory milestone announcement.
2025-01-15 English
Teva becomes strategic commercialization partner for Formycons biosimilar candidate FYB203 (Eylea/ aflibercept) in major parts of Europe and Israel
M&A Activity Classification · 99% confidence The document is a press release dated January 13, 2025, announcing a strategic commercialization partnership between Formycon AG and Teva Pharmaceuticals regarding a biosimilar candidate (FYB203). It details licensing terms, product supply, and market strategy. This type of announcement, which is a material business development but not a formal regulatory financial filing (like 10-K, IR, or ER), is best classified as a general corporate announcement. Since it is a news release disseminated via EQS News, and it doesn't fit the specific categories like M&A (TAR), Capital Change (CAP), or Director Dealing (DIRS), the most appropriate general category is Regulatory Filings (RNS), which serves as the fallback for miscellaneous corporate news releases that are not otherwise specified, especially when they are not the actual financial report itself.
2025-01-14 English
Teva becomes strategic commercialization partner for Formycons biosimilar candidate FYB203 (Eylea/ aflibercept) in major parts of Europe and Israel
M&A Activity Classification · 99% confidence The document is a press release dated January 13, 2025, announcing a strategic commercialization partnership between Formycon AG and Teva Pharmaceuticals regarding a biosimilar candidate (FYB203). It details licensing terms, product supply, and market strategy. This type of announcement, which is a material business development but not a formal regulatory financial filing (like 10-K, IR, or ER), is best classified as a general corporate announcement. Since it is a news release disseminated via EQS News, and it doesn't fit the specific categories like M&A (TAR), Capital Change (CAP), or Director Dealing (DIRS), the most appropriate general category is Regulatory Filings (RNS), which serves as the fallback for miscellaneous corporate news releases that are not otherwise specified, especially when they are not the actual financial report itself.
2025-01-13 English
Formycon included in TecDAX Index of Deutsche Borse
Regulatory Filings Classification · 100% confidence The document is a press release announcing that Formycon AG will be included in the TecDAX Index of Deutsche Börse, effective January 13, 2025. It discusses stock market positioning, index inclusion, and general business performance, but it is not a formal regulatory filing like a 10-K, an earnings release (ER), or a quarterly report (IR). It is a general corporate announcement regarding market status and index changes. Since it doesn't fit the specific categories like Director's Dealing (DIRS), Dividend Notice (DIV), or Capital Change (CAP), and it is a formal news release disseminated via EQS, the most appropriate general category is Regulatory Filings (RNS), which serves as the fallback for miscellaneous corporate news that doesn't fit a more specific financial report type.
2025-01-10 English
Formycon included in TecDAX Index of Deutsche Borse
Regulatory Filings Classification · 100% confidence The document is a press release dated January 9, 2025, announcing that Formycon AG will be included in the TecDAX Index of Deutsche Börse, effective January 13, 2025. This is a corporate event announcement concerning stock market positioning and index inclusion, not a primary financial report (like 10-K or IR), a formal voting result (DVA), or a management change (MANG). It is a general corporate news item disseminated via EQS News. Since it does not fit the specific categories like Earnings Release (ER), Capital Update (CAP), or Director's Dealing (DIRS), and it is a standard corporate announcement, the most appropriate general category is Regulatory Filings (RNS), which serves as a fallback for miscellaneous regulatory/corporate news that doesn't fit elsewhere, although it is primarily a news release about index inclusion.
2025-01-09 English
Formycon and Fresenius Kabi Canada receive Health Canadas approval for FYB202/Otulfi (ustekinumab), a biosimilar to Stelara
Regulatory Filings Classification · 100% confidence The document is a press release dated January 8, 2025, announcing that Formycon and Fresenius Kabi received regulatory approval from Health Canada for their biosimilar product, FYB202/Otulfi®. The text explicitly mentions 'Regulatory Approval' as a key word and details the approval status from various regulatory bodies (Health Canada, FDA, European Commission). This type of announcement, detailing a specific regulatory milestone (approval of a drug/product), is best classified as a general Regulatory Filing or announcement, as it does not fit the specific definitions for financial reports (10-K, IR, ER, MRQ) or corporate governance/management changes (MANG, DIRS, DEF 14A). Since it is a specific regulatory event announcement, and 'Regulatory Filings' (RNS) is the designated fallback for miscellaneous regulatory announcements that don't fit other specific categories, RNS is the most appropriate classification.
2025-01-09 English

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