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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 2022-08-03 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 announces FDA approval of FYB201/CIMERLITM1 (ranibizumab-eqrn) as a Biosimilar interchangeable with Lucentis2
Regulatory Filings Classification · 100% confidence The document is an 'Ad-hoc' announcement dated August 3, 2022, disclosing 'inside information' according to MAR Regulation (EU) No 596/2014. The core content is the announcement that Formycon's biosimilar product received FDA approval for interchangeability. This is a specific, material corporate event announcement, not a comprehensive annual report (10-K), an interim report (IR), or a general earnings release (ER). It is a regulatory disclosure concerning a product/regulatory milestone. Since there is no specific category for 'Regulatory Approval/Product Launch' and it is a material, non-financial results announcement, it fits best under the general 'Regulatory Filings' (RNS) category, which serves as a fallback for significant, non-standard announcements, or potentially a general announcement that doesn't fit the other specific categories like M&A (TAR) or Capital Change (CAP). Given the nature of the announcement (FDA approval), RNS is the most appropriate general regulatory filing category.
2022-08-03 English
Formycon Reports on Virtual Annual General Meeting 2022
AGM Information Classification · 99% confidence The document is titled "Formycon Reports on Virtual Annual General Meeting 2022" and explicitly details the outcomes of the Annual General Meeting (AGM) held on June 30, 2022. Key events mentioned include shareholder approval of agenda items, ratification of the Management and Supervisory Boards, and the election of a new board member. This content directly relates to the proceedings and results of an AGM. Therefore, the appropriate classification is AGM Information (AGM-R). The document is a report/summary of the meeting, not just an announcement of a future meeting or a proxy solicitation.
2022-07-01 English
Formycon AG announces amendment to the proposal for election of a Supervisory Board member (agenda item 9) in the context of the Annual General Meeting on June 30, 2022
AGM Information Classification · 98% confidence The document is a press release dated June 28, 2022, announcing an amendment to the proposal for the election of a Supervisory Board member (agenda item 9) specifically in the context of the upcoming Annual General Meeting (AGM) scheduled for June 30, 2022. While it relates to the AGM, the core content is an announcement about a change in a proposal for a board election, which falls under governance or management updates. However, since the document explicitly mentions the 'Annual General Meeting' and discusses changes to the agenda items for that meeting, it is most closely related to the AGM process. The specific nature of the announcement (amendment to an election proposal for the AGM) makes 'AGM-R' (AGM Information) the most appropriate fit, as it is material directly related to the proceedings of the AGM. It is not a general Board/Management change (MANG) because it is tied directly to the shareholder meeting agenda, nor is it a DEF 14A (Remuneration) or DVA (Voting Results).
2022-06-28 English
FYB201, Formycon's biosimilar for Lucentis (ranibizumab), receives CHMP recommendation from EMA
Legal Proceedings Report Classification · 99% confidence The document is an 'Ad-hoc' announcement dated June 24, 2022, disclosing 'inside information' according to MAR Regulation (EU) No 596/2014. The core content is the announcement that Formycon's biosimilar (FYB201) received a positive opinion (recommendation for approval) from the CHMP of the EMA. This is a specific regulatory event update concerning product development/approval status, not a comprehensive financial report (like 10-K or IR), a management change (MANG), or a dividend notice (DIV). It is a specific regulatory/legal update regarding a product's status. While it mentions 'Interim Report' in the keywords, the content itself is purely about the regulatory recommendation. This type of announcement, detailing a significant regulatory milestone or legal development, fits best under the general 'Regulatory Filings' (RNS) category, as it is a mandatory disclosure of material non-public information, or potentially 'Legal Proceedings Report' (LTR) if interpreted broadly as regulatory action, but RNS is the standard fallback for general regulatory news not covered by other specific financial forms. Given the nature of the disclosure (EMA recommendation), RNS is the most appropriate general regulatory disclosure category.
2022-06-24 English
Formycon Reports First Quarter 2022 Financial Results and Announces Development Start of two New Biosimilar Candidates FYB208 and FYB209
Earnings Release Classification · 100% confidence The document is titled "Formycon Reports First Quarter 2022 Financial Results and Announces Development Start of two New Biosimilar Candidates FYB208 and FYB209". It explicitly details sales, EBITDA, EBIT, and net results for the first quarter of 2022, including comparisons to the previous year's first quarter. This content structure—reporting on a period shorter than a full year with detailed financial figures—is characteristic of an Interim/Quarterly Report (IR). Although it is presented as a press release via DGAP, the core content is the comprehensive quarterly financial disclosure, not just a brief announcement of results (ER) or a simple announcement of the report's publication (RPA). Since it contains the actual financial figures for the quarter, it is classified as IR. Q1 2022
2022-06-21 English
Formycon publishes Update on Development Projects
Regulatory Filings Classification · 99% confidence The document is titled "Formycon publishes Update on Development Projects" and is dated June 17, 2022. It provides detailed updates on several biosimilar development pipelines (FYB201, FYB202, FYB203, FYB207), including clinical trial statuses (last-patient-out/in), expected data release timelines (e.g., 'data expected by end of July 2022'), regulatory submission plans (EMA/FDA), and strategic outlook. This content is characteristic of a comprehensive update provided to investors regarding ongoing operations and pipeline progress, which aligns best with an Investor Presentation (IP) or a detailed Management Discussion and Analysis (MDA). Since it is presented as a press release detailing operational and strategic progress rather than just the initial highlights of quarterly earnings (ER) or a formal, comprehensive annual/interim report (10-K/IR), 'Investor Presentation' (IP) is the most fitting category for this type of detailed, forward-looking operational update, although it is delivered via a news release format. Given the depth of pipeline detail, it functions as an investor briefing document.
2022-06-17 English

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