Press Releases
Information for the media and for our investors
Formycon and Fresenius Kabi announce European Medicines Agency Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate
Formycon AG and its commercialization partner Fresenius Kabi today announced that the European Medicines Agency (“EMA”) has accepted the Marketing Authorization Application (“MAA”) for FYB202, a proposed biosimilar candidate to Stelara®.
September 29, 2023
Formycon reports successful first half of 2023
Formycon AG today published the financial results and the corporate development of Formycon Group for the first half of 2023.
August 30, 2023
Formycon announces File Acceptance for FYB203, a biosimilar candidate to Eylea® (aflibercept), by the U.S. Food and Drug Administration (FDA)
Formycon AG and its license partner Klinge Biopharma GmbH announce that the U.S. Food and Drug Administration has accepted the biologics license application for FYB203, a biosimilar candidate to Eylea®, for review
August 29, 2023
Formycon hosts conference call on financial and earnings position for H1 2023
Formycon AG today announced details of its financial and earnings conference call for the first half of 2023.
August 23, 2023
Formycon and Fresenius Kabi secure U.S. License Date for proposed Ustekinumab Biosimilar
Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson for the U.S., concerning FYB202
August 7, 2023
Formycon reports on the regular Annual General Meeting
On July 25, 2023, Formycon AG held its regular Annual General Meeting in person in Munich.
July 26, 2023
Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)
Formycon and its license partner Klinge Biopharma GmbH announce that the biologics license application for FYB203 has been submitted to the U.S. Food and Drug Administration in line with the initial schedule.
June 29, 2023
Formycon at the Jefferies Global Healthcare Conference 2023 – Presentation via Livestream
Formycon presentation at Jefferies Global Healthcare Conference on June 08, 2023 at 14:30 (CET)
June 6, 2023
Formycon reports results for the first quarter 2023
Formycon AG today published the unaudited results for the first quarter of the fiscal year 2023.
May 30, 2023
Formycon Announces Participation in International Investor Conferences in Q2/2023
Formycon AG today announced that members of the Management Board will present at international investor conferences in the second quarter of 2023.
May 10, 2023
Formycon publishes results for financial year 2022
Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published its financial results and business development for the fiscal year 2022.
April 27, 2023
Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development
Formycon AG today today announced the successful conclusion of the extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara®.
April 25, 2023
Enno Spillner appointed Chief Financial Officer (CFO) of Formycon AG
Formycon AG today announced that the Company's Supervisory Board has appointed Mr. Enno Spillner to the Company's Executive Board as Chief Financial Officer (CFO) effective April 1, 2023.
February 7, 2023
Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study
Formycon AG today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea®.
February 6, 2023
Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Formycon AG as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), announced the conclusion of a global license agreement with Fresenius Kabi AG.
February 2, 2023
Formycon AG announces result of private placement and sets placement price for the new shares from the capital increase
Munich – On the basis of the bookbuilding procedure carried out as part of the private placement, the Management Board, with the approval of the Supervisory Board, set a placement price of EUR 77.00 per new share, resulting in gross proceeds from the offering of EUR 70,070,000.00 before commissions and costs. The New Shares correspond to approximately 6.02% of the Company's currently issued share capital.
February 2, 2023
Formycon AG upsizes capital increase from authorized capital following strong demand
Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon” or “Company") announces that, following strong demand, the Company has decided to upsize their previously announced capital increase from authorized capital from approx. 5% to in total approx. 6% of the outstanding share capital.
February 1, 2023
Formycon AG plans capital increase of approx. 5% of the share capital by way of an accelerated bookbuilding procedure to finance further growth
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) intends to issue approx. 5% of the issued share capital of the Company, representing approx. 750,000 new shares (the "New Shares").
February 1, 2023
Formycon AG announces global license agreement with Fresenius Kabi for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), today announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”).
February 1, 2023
Formycon announces binding Term Sheet between Klinge Biopharma and Coherus BioSciences for the exclusive commercialization of FYB203, a biosimilar candidate to Eylea®1, in the United States
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that Klinge Biopharma GmbH, the exclusive owner of the global commercialization rights of FYB203, Formycon’s biosimilar candidate to Eylea® (aflibercept), has entered into a binding term sheet with Coherus BioSciences, Inc. (“Coherus”) for the exclusive commercialization of FYB203 in the United States (U.S.).
January 9, 2023