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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 2023-08-29 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 announces File Acceptance for FYB203, a biosimilar candidate to Eylea1 (aflibercept), by the U.S. Food and Drug Administration (FDA)
Legal Proceedings Report Classification · 99% confidence The document is a press release dated August 29, 2023, announcing that the U.S. Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for FYB203 for review. The keywords include 'Press Release', 'announces File Acceptance', 'U.S. Food and Drug Administration (FDA)', and 'Regulatory Admission/Miscellaneous' in the metadata. This is a specific corporate announcement regarding a regulatory step (BLA acceptance) but is not a comprehensive financial report (like 10-K or IR) or a general regulatory filing fallback (RNS). It is a specific update on product development/regulatory status. Since there is no specific category for 'Regulatory Acceptance Announcement' outside of general regulatory filings, and it is not an Earnings Release (ER), Capital Update (CAP), or a general Legal Report (LTR), the most appropriate classification among the provided options is the general Regulatory Filings category (RNS), as it is a formal announcement disseminated via EQS News regarding a regulatory event.
2023-08-29 English
Formycon hosts conference call on financial and earnings position for H1 2023
Report Publication Announcement Classification · 100% confidence The document is a press release announcing an upcoming conference call to discuss H1 2023 financial results. It does not contain the actual financial statements or the report itself, but rather provides details on when the report will be published and how to access the subsequent conference call. Per the 'Menu vs Meal' rule, this is an announcement regarding the publication of a report, making it a Report Publication Announcement (RPA). H1 2023
2023-08-23 English
Formycon and Fresenius Kabi secure U.S. License Date for proposed Ustekinumab Biosimilar
Regulatory Filings Classification · 95% confidence The document is a press release dated August 7, 2023, announcing a settlement agreement between Formycon and Fresenius Kabi with Johnson & Johnson regarding the U.S. launch date for a biosimilar (FYB202). It discusses future regulatory steps (BLA submission) and commercialization timelines. This type of announcement, which details a significant business development, partnership outcome, or legal resolution, is typically classified as a general Regulatory Filing or News Release. Since there is no specific category for 'Settlement Announcement' or 'Partnership Update' that fits better, and it is not a full financial report (10-K, IR), earnings release (ER), or management discussion (MDA), the most appropriate general category is Regulatory Filings (RNS), which serves as a broad category for official corporate news disseminated via services like EQS News.
2023-08-07 English
Formycon reports on the regular Annual General Meeting
AGM Information Classification · 99% confidence The document explicitly states in the title and body: "Formycon reports on the regular Annual General Meeting". It details the outcomes of the meeting, including shareholder approvals, ratification of the board, and election of a new member. This content directly corresponds to the definition of AGM Information (AGM-R), which covers presentations and materials shared during the Annual General Meeting.
2023-07-26 English
Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)
Legal Proceedings Report Classification · 99% confidence The document is a press release dated June 29, 2023, announcing that Formycon AG has submitted a Biologics License Application (BLA) for its biosimilar candidate FYB203 to the U.S. Food and Drug Administration (FDA). This is a specific regulatory event announcement concerning product development and submission, not a comprehensive periodic report (like 10-K or IR) or a general earnings release (ER). Since the filing describes a specific regulatory action (submission to the FDA) and is presented as a news release, it fits best under the general 'Regulatory Filings' category (RNS) as a specific regulatory update that isn't covered by other specific codes like DIRS, DIV, or CAP. It is not a transcript (CT), an investor presentation (IP), or a formal audit report (AR). Given the nature of the announcement (a key regulatory milestone), RNS is the most appropriate general regulatory filing category.
2023-06-29 English
Formycon reports results for the first quarter 2023
Earnings Release Classification · 100% confidence The document is titled "Formycon reports results for the first quarter 2023" and explicitly states it is publishing the "unaudited results for the first quarter of the fiscal year 2023." It contains key financial highlights (revenues, EBITDA, EBIT, net result) for a specific interim period (Q1 2023) and confirms the overall guidance for the fiscal year. This content structure aligns perfectly with an Interim/Quarterly Report, which is classified as 'IR'. It is not a full Annual Report (10-K), nor is it just a brief announcement of a report (RPA), as it contains substantial financial details. It is also not a Call Transcript (CT) or a Management Discussion & Analysis (MDA), although it contains some management commentary, the primary focus is the structured quarterly financial results. Q1 2023
2023-05-30 English

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