Archive


Information for the media and for our investors

Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Formycon AG and its license partner Klinge Biopharma GmbH announce that the European Medicines Agency has accepted the marketing authorization application for FYB203, for review.


Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis®

Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the “Notice of Compliance” (NOC) for Ranopto®(Ranibizumab), a biosimilar to Lucentis®, for the treatment of several serious retinal diseases in Canada.


Formycon announces participation in international Investor Conferences in Q1/2024

Formycon AG today announced that members of the Management Board plan to be present at the following investor conferences in the first quarter of 2024 ...


Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Formycon AG and its commercialization partner Fresenius Kabi today announced that the FDA has accepted the Biologics License Application for FYB202.


Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Formycon AG and its license partner Klinge Biopharma GmbH announce that the marketing authorization application for the Aflibercept biosimilar candidate FYB203, has been submitted to the European Medicines Agency.


Formycon publishes nine-month results for 2023

Formycon AG today published the financial results and the corporate development of Formycon Group for the first half of 2023.


Formycon hosts conference call on nine-month figures 2023 and presents at further investor conferences

Formycon will introduce the company's development and nine-month figures 2023 in a conference call on November 13, 2023. The conference call, streamed live on the internet, will be held in English on November 13, 2023 at 3:00 p.m. (CEST).


Formycon Ranibizumab Biosimilar FYB201/CIMERLI®1 achieved 25% market share2 in the United States

Formycons commercialization partner Coherus BioSciences, Inc. announced that sales of CIMERLI® (ranibizumab-eqrn) to retinal specialists in the United States of America (“U.S.”) have exceeded 100,000 doses since commercial launch on October 3, 2022.


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®.


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.


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


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.


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


Formycon reports on the regular Annual General Meeting

On July 25, 2023, Formycon AG held its regular Annual General Meeting in person in Munich.


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.


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)


Formycon reports results for the first quarter 2023

Formycon AG today published the unaudited results for the first quarter of the fiscal year 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.


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.


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®.


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.


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®.


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.


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.


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.


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").


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”).


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.).


Formycon Reports its Nine-month Figures for 2022

Formycon AG has today announced its results for the first nine months of the 2022 fiscal year.


Broad-acting antiviral SARS-CoV-2 drug FYB207 shows longer half-life and improved efficacy through optimized molecular design in preclinical studies

Formycon AG has today published preclinical in vivo results for the development of their COVID-19 drug FYB207.


Formycon reports final figures for the first half of 2022

Formycon AG today published its half-year report 2022, confirming the preliminary operating figures for the first half of 2022 already announced on September 06, 2022.


Formycon publishes details of a previously undisclosed pipeline project – FYB206 is a biosimilar candidate for Keytruda®* (pembrolizumab)

Formycon AG today announced details of a previously undisclosed project in its development pipeline. FYB206 is a biosimilar candidate for Keytruda® (pembrolizumab) and the development is at an advanced preclinical stage.


Formycon publishes preliminary figures for the first half of 2022

Formycon AG today announced its preliminary and unaudited financial figures for the first half of 2022. Reporting at Group level is performed for the first time in accordance with IFRS (International Financial Reporting Standards).


European Commission approves FYB201/Ranivisio®1 (Ranivisio – Ranibizumab), a biosimilar to Lucentis®2

Formycon AG, Polpharma Biologics Group BV and Bioeq AG jointly announce that the European Commission has granted marketing authorization for Ranivisio® (Ranivisio - Ranibizumab), a biosimilar to Lucentis® (ranibizumab-injection), for the treatment for several serious retinal diseases in the European Union.


Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the European Comission (“EC”) today has granted marketing authorization (“MA”) for Ranivisio®, a biosimilar to Lucentis® (ranibizumab-injection) for medical use in the European Union (“EU”).


Formycon’s Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara®* in Phase III Study

Formycon AG today reported positive preliminary efficacy and safety data from VESPUCCI Phase III clinical trial for FYB202, its proposed biosimilar version of Stelara®(Ustekinumab).


U.S. Food and Drug Administration (FDA) approved FYB201/CIMERLITM1 (ranibizumab-eqrn), the first and only biosimilar interchangeable with Lucentis®2

CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity of 12 month after market launch that is indicated for the treatment of all five Lucentis® indications and as such is a new medical option for patients with serious retinal diseases.


Formycon announces FDA approval of FYB201/CIMERLITM1 (ranibizumab-eqrn) as a Biosimilar interchangeable with Lucentis®2

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).

FYB201 was developed by Bioeq AG, a Joint...


Formycon Reports on Virtual Annual General Meeting 2022

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on June 30, 2022 in virtual form.


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

Munich – Based on the resolution of the Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) dated June 27, 2022, the election proposal under agenda item 9 of the agenda for the 2022 Annual General Meeting of Formycon AG published in the Federal Gazette on May 20, 2022 shall be...


FYB201, Formycon’s biosimilar for Lucentis® (ranibizumab), receives CHMP recommendation from EMA

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announce that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") today issued a positive opinion for FYB201, a biosimilar to...


Formycon Reports First Quarter 2022 Financial Results and Announces Development Start of two New Biosimilar Candidates FYB208 and FYB209

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today presented the sales and earnings figures for the first quarter of 2022, demonstrating a start to the financial year that meets expectations.

Group turnover including other income amounted to a total of EUR 8.2 million as March 31,...


Formycon publishes Update on Development Projects

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) („Formycon“) today announced an update on their development projects.

FYB201, Formycons biosimilar to Lucentis® (ranibizumab), was recently approved by the British Medicines Agency MHRA (Medicines and Healthcare products...


Formycon appoints Dr. Stefan Glombitza as CEO and sets the course for the future by appointing the two experienced pharmaceutical managers Nicola Mikulcik and Dr. Andreas Seidl to the Executive Board

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon") today announced changes to its Executive Board, setting the stage for continued and stable leadership as the company moves towards becoming a global and fully integrated biosimilars pharmaceutical company.

Today and...


Formycon announces changes to its Executive Board

Munich – Today and effective July 1, 2022, the Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon") appointed Dr. Stefan Glombitza, who has led Formycon's operational development activities as Chief Operating Officer (COO) since 2016, as Chief Executive Officer...


Formycon Publishes Annual Financial Statements for the 2021 Financial Year

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today released its financials for 2021.

The focus in 2021 was on the further development of the current biosimilar candidates as well as the COVID-19 drug (FYB207). The development activities of the late-stage biosimilar projects...


United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) grants Marketing Authorization for FYB201, Formycon’s Biosimilar for Lucentis®¹, to be Commercialized by Teva as ONGAVIA®

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to...


FYB201, Formycon’s Biosimilar for Lucentis®¹, achieves Marketing Authorization in United Kingdom

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to...


Formycon AG and ATHOS KG announce closing of transaction to acquire biosimilar assets FYB201 and FYB202 as well as Bioeq GmbH

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon”) and ATHOS KG (“ATHOS”) announce the closing of the acquisition of the biosimilar assets FYB201 and FYB202 as well as Bioeq GmbH ("Bioeq") with the registration of the implementation of the non-cash capital increase in...


Formycon is acquiring the biosimilar assets FYB201 and FYB202 and strengthening its position in the global growth market of biosimilars through long-term partnership with ATHOS KG

The transaction creates key enablers for further expanding Formycon’s position as a company operating on the global stage in the growth market for biosimilars


Formycon and ATHOS KG merge development activities through the acquisition of biosimilar assets in a long-term strategic partnership

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and SCG Cell Therapy Pte Ltd ("SCG") today announced that they have entered into a collaboration and license agreement for the development and commercialization of Formycon's proprietary COVID-19 drug FYB207. Under the terms of the agreement,...


MS Pharma becomes Partner for the Commercialization of FYB201, Formycon’s Biosimilar Candidate to Lucentis(R)1 (ranibizumab), in the MENA Region

Munich - Bioeq AG ("Bioeq"), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon's biosimilar candidate for Lucentis(R) (ranibizumab), has informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) that it has entered into an exclusive partnership with MS...


Formycon and Scientists from TUM publish new Data on broadly effective SARS-CoV-2 antiviral Drug FYB207

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University of Munich (TUM), today announced the publication of new in vitro data on the...


Formycon Reports its Nine-Month Figures for 2021

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine month of the 2021 fiscal year.

The key financial figures of the Formycon Group also developed as expected at the end of the third quarter. Turnover within the Group which, alongside the...


Formycon and SCG Cell Therapy Announce Collaboration and License Agreement for Formycon’s COVID-19 Drug FYB207

“We are very glad about the collaboration with SCG which allows us to accelerate the development and commercialization of our COVID-19 drug FYB207 in the most populated region of the world”, says Dr. Carsten Brockmeyer, CEO of Formycon


Formycon Concludes Collaboration and License Agreement with SCG Cell Therapy for its COVID-19 Drug FYB207 for the Asia Pacific Region

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and SCG Cell Therapy Pte Ltd ("SCG") today announced that they have entered into a collaboration and license agreement for the development and commercialization of Formycon's proprietary COVID-19 drug FYB207. Under the terms of the agreement,...


Formycon and Bioeq announce File Acceptance for FYB201, a biosimilar candidate to Lucentis® (ranibizumab) by the U.S. Food and Drug Administration (FDA)

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis®1, for review and assigned a target action date for the application for August 2022.


Formycon Reports on Virtual Annual General Meeting 2021

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on September 27, 2021 - for the protection of all persons involved - in virtual form.

The shareholders were able to follow the virtual Annual General Meeting live in picture and sound via the Company's...


Formycon Publishes Half-Year Results for 2021

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2021.

On the day of reporting, June 30, 2021, the Formycon Group's financial figures were as forecast. Turnover within the Group which, alongside the joint-stock company...


Formycon’s COVID-19 drug FYB207 Wins Prestigious Pharma Trend Image & Innovation Award 2021

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) yesterday received the Pharma Trend Image & Innovation "Most Innovative Product(R)" Award in the category of Leap Innovations for its COVID-19 drug development FYB207.

For what is now the 22nd time, the Pharma Trend Image &...


Formycon reports on the status of FYB207 development

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today provided an update on the development status of its COVID-19 drug FYB207.

SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Formycon has...


Formycon and Bioeq announce submission of the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the U.S. Food and Drug Administration (FDA)

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG ("Bioeq") announce that the biologics license application (BLA) for FYB201, Formycon's biosimilar candidate to Lucentis(R), has been recently submitted to the U.S. Food and Drug Administration...


Formycon receives Euro 12.7 million grant for further development of COVID-19 drug FYB207 as part of the Bavarian Therapy Strategy to combat the COVID-19 pandemic

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced today that it has received the final notification for a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy in the amount of Euro 12.7 million to support the further development of the COVID-19 drug...


Formycon Reports Financial Results for the First Quarter of 2021

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today presented the sales and earnings figures for the first quarter of 2021, demonstrating a positive start to the financial year.

Consolidated sales including other income increased by around EUR 2.2 million to a total of EUR 9.4...


Formycon and Bioeq announce submission of the marketing authorization application for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the European Medicines Agency (EMA)

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG announce that the marketing authorization application (MAA) for FYB201, Formycon's biosimilar candidate to Lucentis(R) (ranibizumab), has been submitted to the European Medicines Agency...


Teva Pharmaceutical Industries Ltd. becomes strategic partner for the commercialization of FYB201, Formycon’s biosimilar candidate to Lucentis(R)1 (ranibizumab) in Europe, Canada, Israel and New Zealand

Munich - Bioeq AG ("Bioeq"), the exclusive owner of the global commercialization rights of FYB201, Formycon's biosimilar candidate to Lucentis(R) (ranibizumab), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), that an exclusive strategic partnership for commercialization of FYB201 in...


Formycon announces conclusion of exclusive commercialization agreement between Bioeq AG and Teva Pharmaceutical Industries Ltd. for FYB201 in Europe, Canada, Israel and New Zealand

Munich - Bioeq AG ("Bioeq"), the exclusive owner of the global commercialization rights of Formycon's biosimilar candidate to Lucentis(R)1 (ranibizumab), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), that an exclusive strategic partnership for commercialization of FYB201 in...


Formycon Publishes Annual Financial Statements for the 2020 Financial Year

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published its financial performance indicators for 2020 and has recorded a solid financial year.

On the day of reporting, December 31, 2020, the Formycon Group's commercial figures had developed as forecast. Consolidated group...


Formycon receives approval for early action for COVID-19 drug FYB207 as part of a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy (StMWi)

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the approval of early action for its COVID-19 drug (FYB207) by the Bavarian Ministry of Economic Affairs, Regional Development and Energy (StMWi). The requested grant is expected to support the further development of FYB207...


Formycon’s COVID-19 Drug FYB207 even more efficient against SARS-CoV-2 Mutant B.1.1.7

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University of Munich, today announced new results on the in vitro neutralization of SARS-CoV-2...


Formycon and Leukocare cooperate in the development of high-quality biopharmaceuticals

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Leukocare AG today announced a collaboration in the area of high-quality biopharmaceuticals.


Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") confirm the planned timeline for resubmission of the Biologics License Application ("BLA") for their Lucentis(R) biosimilar candidate FYB201 following a successful pre-BLA interaction with the U.S....


Formycon receives positive Scientific Advice from Paul-Ehrlich-Institute for the COVID-19 Drug FYB207 and assures GMP Manufacturing Capacities

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received the consent from the Paul-Ehrlich-Institute (PEI) regarding the proposed development concept for its innovative SARS-CoV-2 blocker FYB207. As result of the Scientific Advice, the Federal Institute for Vaccines and Biomedicines...


Formycon’s Scientific Collaboration Partners present FYB207 Results at International Keystone Symposium

Munich - Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that its academic partners of the Technical University of Munich, present results on Formycon's COVID-19 drug (FYB207).


Formycon Reports on Virtual Annual General Meeting 2020

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on December 10, 2020 - for the protection of all persons involved - in virtual form.


Innovative SARS-CoV-2 Blocker from Formycon Completely Prevents Infection of Cells

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University of Munich, have published results on Formycon's COVID-19-drug (BioRxiv Preprint:


Chief Operating Officer Dr. Stefan Glombitza appointed to Formycon AG’s Management Board for another Four Years

Munich - The Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has extended the appointment of Management Board member Dr. Stefan Glombitza as Chief Operating Officer (COO) until December 31, 2024. With this decision, the supervisory committee is honoring the Formycon manager's...


Formycon Reports its Nine-month Figures for 2020

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its figures for the first nine months of the 2020 fiscal year.

Sales and other income of the Formycon Group totaled EUR 23.5 million as of September 30 of this year (prior year period: EUR 26.8 million). Earnings...


Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab)

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH announced the dosage of the first patient in the Phase III clinical trial (first-patient-in). The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference...


Formycon informs about the modified BLA-Submission Strategy for its Lucentis(R)* Biosimilar-Candidate FYB201

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announced today that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted.

The approval for FYB201 will be requested directly for a large commercial...


Formycon Announces Virtual Annual General Meeting for December 10, 2020

Munich - Against the background of the COVID-19 pandemic, which is set to continue for the foreseeable future, the rules of conduct adopted by the Free State of Bavaria which are still in force, and the objective of avoiding health risks, the Management Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has, with the approval of the company's Supervisory Board on the basis of Article 2 of the law intended to mitigate the consequences of the COVID-19 pandemic in civil, insolvency and criminal proceedings of March 27, 2020, and for the benefit of the health of shareholders, decided to hold the Annual General Meeting (AGM) in a virtual format.


Formycon Receives Funding for COVID-19 Drug Research from the Bavarian Research Foundation

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received a grant from the Bavarian Research Foundation for the project "Characterization of ACE2-lgG constructs" amounting to Euro 290,000.

SARS-CoV-2 requires the binding of the virus spike protein to the membrane angiotensin...


Strategic Investor Active Ownership Group Subscribes for Cash Capital Increase of EUR 25.75 million

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the subscription of a cash capital increase by the Active Ownership Group in a private placement. Based on the resolutions of the Management Board and the Supervisory Board, the Company's share capital will be increased by...


Formycon places Cash Capital Increase of 25.75 Million Euros with Strategic Investor

Munich - The Management Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) resolved yesterday, with the approval of the Supervisory Board, to increase the company's capital against cash contributions by partially utilizing the approved capital. The Company's share capital of currently EUR...


Formycon Announces Half-Year Results for 2020

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2020.

On the day of reporting, June 30, 2020, the Formycon Group's commercial figures developed as forecasted. The Group's turnover which, in addition to the joint-stock...


Formycon and Bioeq Enroll First Patient in Phase III Study with Aflibercept Biosimilar (FYB203)

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH have today announced the launch of the randomized, double-blind, multi-center phase III study for FYB203, a biosimilar candidate to Eylea®.


Formycon Reports Financial Results for the First Quarter of 2020

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today presented the sales and earnings figures for the first quarter of 2020, demonstrating a positive start to the financial year. By responding early and implementing appropriate measures to protect employees in the context of the COVID-19...


Formycon Publishes Annual Financial Statements for the 2019 Financial Year

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published its financial performance indicators for 2019 and has recorded a solid financial year.

On the day of reporting, December 31, 2019, the Formycon Group's commercial figures had developed as forecast. Consolidated group...


Formycon Announces Update on Biosimilar Programs

Munich - In consideration of the current developments of the corona pandemic, Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announces news on its development portfolio.

An early reaction and the implementation of appropriate organizational decentralization measures enabled Formycon to...


Formycon is postponing the general assembly into the fourth quarter of 2020 to maintain the possibility of an event in person

Munich - The board of management and the supervisory board of Formycon AG have decided to postpone the general assembly, which was originally scheduled for June 30, 2020 to December 10, 2020. This decision was made in light of the ongoing corona pandemic in order to protect the shareholders,...


Formycon Starts Antibody-Based Drug Development for COVID-19

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the start of development of COVID-19 drugs. The company develops biological COVID-19 drugs using its clinically validated antibody-based protein drug technology platform, leveraging computer-aided structural protein design as...


Formycon informs about the current Status of the BLA Review Process of the Lucentis®Biosimilar Candidate FYB201

Formycon AG and its licensing partner Bioeq announce today, that the U.S. Food and Drug Administration (FDA) has requested additional data as part of the review process of the BLA for the Lucentis® biosimilar candidate FYB201, submitted by Bioeq in December 2019.


Formycon Reports Its Nine-Month Figures For 2019

The company's group sales, including other earnings, as of September 30 of this year, amount to EUR 26.8 million while EBITDA was well-balanced and net result totaled around EUR -0.7 million. Formycon Group's stocks of liquid assets, including short-term receivables from deliveries and services as well as other assets are totaling EUR 29.2 million on the day of reporting.


Bioeq IP AG Exclusively Licenses US Marketing Rights For FYB201 To Coherus BioSciences, Inc.

Bioeq IP AG, the exclusive owner of the global commercialization rights of Formycon’s FYB201 has signed a license and development agreement with Coherus BioSciences, Inc. The US Biosimilar-specialist, headquartered in California, will exclusively market and distribute Formycon's biosimilar candidate to Lucentis® (FYB201) in the United States of America (US).


Formycon Announces Start of Phase I Clinical Trial With Ustekinumab Biosimilar Candidate FYB202

Formycon AG today announced the start of a Phase I clinical trial comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara® (USA / EU). Dosing of study subjects started last week.


Formycon Publishes Half-Year Results for 2019

Formycon AG has today announced its financial results for the first half of 2019. With a Group turnover of Euro 17,2 million and a period result of Euro -0,7 million Formycon Group's commercial figures were as forcast.


Formycon Reports on Annual General Meeting 2019

Formycons shareholders followed the proposals of the Board of Management and the Supervisory Board and approved all resolutions proposed by the management with large majorities in each case.


Formycon Reports Further Course of Capital Measure

With the agreement dated June 26, 2019, Wendeln & Cie. KG, an asset management company of Mr. Peter Wendeln (anchor shareholder and long-standing member of the Supervisory Board of Formycon AG), acquired all rights from the certificate of subscription as well as the 577,397 shares in Formycon AG from the cash capital increase.


Formycon Publishes Figures for the First Quarter of 2019

The Group sales, including other earnings, as of March 31 of this year amount to EUR 9.5 million. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR 0.5 million. The operating result (EBIT) as well as the quarterly result totaled around EUR 0.2 Million. The reported sales revenues result from reimbursements for development work in the licensed-out projects or projects developed in partnership. For the 2019 fiscal year, revenues in the amount of approximately EUR 35.0 million are expected at the group level.


Formycon Reports Latest Status of Capital Increase

As of today, totaling EUR 5,000,000.00, have been paid to the company’s capital increase account. The signatory's debt contribution amounting to EUR 12,264,170.30 is therefore still outstanding. The shares have so far not been delivered due to the as yet unsettled payment.


Formycon Reports Successful 2018 Financial Year

The Group's turnover rose compared to last year (Euro 29 million) by 48 percent to around Euro 43 million, exceeding forecasts. The earnings before interest, tax, depreciation and amortization on fixed and immaterial assets (EBITDA) were Euro 8 million (previous year Euro -0.8 million), which is significantly higher than last year’s figure.


Formycon Announces News on Development Portfolio

Formycon has published news on its development portfolio. The FDA submission of FYB201 is expected for the beginning of the fourth quarter of this year. The submission to the European Medicines Agency (EMA) is scheduled for the first quarter of 2020. Also significant progress have been achieved with FYB202 and FYB203.


Strategic Investor M&H Equity AG Subscribes Cash Capital Increase of Euro 17.3 Million

The Swiss company M&H Equity AG from Heerbrugg in the Canton of St. Gallen is a strategic investor with a long-term investment horizon. The funds acquired from the capital increase should be used primarily to develop the company’s own biosimilar products and further increase the value of the pipeline.


Formycon Places Cash Capital Increase of EUR 17.3 Million with Institutional Investor

Strategic investor M&H Equity AG subscribes for a cash capital increase of € 17,264,170.30 million in the context of a private placement with an issue price of 29.90 EUR per share. The funds acquired from the capital increase will be used primarily to develop the company’s own biosimilar products, particularly FYB205.


Formycon Releases Updates on Development Programs and Milestones

For FYB201, new data from the recently completed COLUMBUS-AMD phase III trial in patients with neovascular age-related macular degeneration (nAMD) are available.


Formycon Reports Nine-Month Figures for 2018

The turnover of the Formycon group increased significantly compared with the first nine months of 2017.


Formycon Reports Financial and Operating Results for the First Half Year of 2018

Formycon AG has revealed impressive results for the first half of 2018 both in the development of its product candidates and its business figures. Key milestones were reached on project FYB201, a biosimilar candidate for Lucentis®* (ranibizumab).


Formycon Appoints Development and Production Expert Thomas Siklosi to the Advisory Board

The former board member of Rentschler Biopharma SE is a renowned biotech manager and expert of biologics and biosimilars


Formycon with Significant Growth in Turnover and Earnings in the First Quarter of 2018

Formycon has significantly improved its revenue and earnings in the first quarter of 2018 compared to the same period of the previous year.


Formycon With Successful 2017 Financial Year

Formycon has ended the 2017 financial year successfully and has once again significantly advanced the development of its product candidates.


Formycon and Bioeq Achieve Important Milestone: Biosimilar Ranibizumab Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study

In the COLUMBUS-AMD Trial the primary endpoint has been achieved, thus confirming comparable efficacy between FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD).


Biosimilar Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study

According to an interim result, the primary endpoint has been achieved in the COLUMBUS-AMD phase III trial, which is intended to demonstrate the efficacy, safety and immunogenicity of FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD).


Formycon Ranks 7th in the Financial Times List of Europe’s 1000 Strongest-Growing Companies

Formycon has ranked 7th in the FT1000 list compiled by the highly respected business newspaper the Financial Times and data provider Statista, making it the only biotech company to appear in the top ten.


Formycon and Aristo Pharma are Founding a Joint Venture for the Development of FYB202

Formycon and Aristo Pharma GmbH, a company of the Struengmann-Group, have formed a joint company for the continued development of FYB202, Formycon's biosimilar candidate for Stelara® (ustekinumab).


Formycon Reports Operating and Financial Results for the Third Quarter of 2017

Formycon has again progressed well with the further development of its four biosimilars and confirmed the Euro 25 million sales target for whole of 2017.


Formycon Sets Course for the Future and Confirms Management Board Members until mid-2022

The Supervisory Board of Formycon has extended the appointments of Dr. Carsten Brockmeyer, board member and CEO, and Dr. Nicolas Combé, board member and CFO, until June 30, 2022.


Formycon Reports Financial and Operating Results for the First Half Year of 2017

Formycon has accomplished a successful first half year in 2017. Phase III clinical trial of FYB201 is continuing to progress as planned, the implementation of development cooperation agreement for FYB202 is anticipated for second half of the year


Formycon signs term sheet for development of FYB202 and executes capital increase

Formycon plans to enter into a co-investment arrangement for its biosimilar candidate FYB202 and aims for a participation of up to 30% in worldwide marketing proceeds.


Formycon Publishes Figures for the First Quarter of 2017

The commercial performance of Formycon has again advanced as planned in the first quarter of 2017 and the development of its four biosimilar projects has progressed as expected.


Formycon Announces Details of Further Pipeline Product: FYB202 is a Biosimilar Candidate for Stelara® (ustekinumab)

Formycon has announced details of a further product from its development pipeline: FYB202 is a biosimilar candidate for Stelara®* (ustekinumab).


Formycon With Successful 2016 Financial Year

Formycon has ended the 2016 financial year successfully and significantly advanced the development of its product candidates.


Formycon Plans Change in New SME Stock Exchange Segment “Scale”

Formycon plans, with effect from March 1, 2017, to switch to Deutsche Börse AG’s new stock exchange segment “Scale” for small and medium-sized enterprises (SMEs).


Focus magazine lists Formycon as growth champion repeatedly

Formycon has been named "growth champion 2017" in the category "Chemistry and Pharma" by the news magazine Focus. In the overall ranking, Formycon took second place.


Formycon Makes Good Progress in First Nine Months of 2016

In the first nine months of the 2016 financial year, Formycon has further advanced the development of its drug candidates.


Formycon Wins Award from Stifterverband for Innovative Strength

Formycon has been awarded the Research Seal by the Stifterverband in recognition of its innovative research and development work. With this award, the organization is acknowledging the company’s dedication to the development of biosimilars.


Formycon Reports First Half 2016 Financial and Operating Results

The development of Formycon’s biosimilar candidates has progressed well during the first half of 2016. The company announced this update as it unveiled its 2016 half-year figures.


Formycon Expands Board and Appoints Pharma Top Manager Dr. Stefan Glombitza as Chief Operating Officer

Dr. Stefan Glombitza will join Formycon on October 1, 2016 and add his strengths to the Management Board. He will in future act as Chief Operating Officer (COO), focusing especially on the company's operational development activities


Formycon CEO Dr. Carsten Brockmeyer once again honored as one of the world’s most influential people in the medicines industry

Dr. Carsten Brockmeyer, CEO of Formycon AG, has again been chosen as one of the world’s top 100 most influential people in the pharmaceutical sector by the trade magazine “The Medicine Maker”


Formycon Publishes Figures for the First Quarter of 2016

The first quarter of 2016 has been successful for Formycon both in operational and financial terms. On the furthest-progressed development project FYB201, a biosimilar candidate for Lucentis®*, the first patient was enrolled in February of this year in the phase III study


Formycon ends 2015 fiscal year with successful results

Formycon has ended the 2015 financial year with both operational and financial success. In the last year, Formycon has made great strides with the initiation of the clinical Phase III study involving the biosimilar candidate FYB201 (ranibizumab) in particular.


Formycon discloses details on second pipeline product – FYB203 is a biosimilar for Eylea® (aflibercept)

Formycon AG has announced details on the second biosimilar product which is jointly developed with Santo Holding GmbH. FYB203 is a biosimilar candidate for Eylea® (aflibercept).


Formycon and bioeq enroll first patient in pivotal phase III study with biosimilar ranibizumab (FYB201)

Formycon AG, Munich, and bioeq GmbH, Holzkirchen, have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®


Formycon appoints biotech expert Professor Johannes Buchner to the Advisory Board

Formycon appoints Johannes Buchner, professor in Biotechnology at the Technical University of Munich, and President of the German Society for Biochemistry and Molecular Biology (GBM), to its Advisory Board


Formycon files multiple patent applications for the pharmaceutical formulation and delivery of intraocular VEGF antagonists

Formycon today announced that it has filed already three patent applications relating to the formulation and intraocular delivery of VEGF antagonists.


Formycon announces results for first nine months of 2015

Formycon has announced a significant increase in its revenue for the first nine months of this year, thus continuing on its path of profitable growth.


Global strategic partners bioeq and Formycon initiate pivotal phase III clinical trial with their Lucentis® biosimilar

Formycon AG, Munich, Germany, and bioeq GmbH, Holzkirchen, Germany, announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis®)


Formycon announces positive financial results for first half of 2015

Formycon has closed the first half of its fiscal year 2015 with successful financial results. Consolidated revenue for the period ending June 30, 2015, was EUR 9.8 million. Net income for the six-month period was EUR 1.53 million.


Formycon AG receives favorable scientific advice from U.S. Food and Drug Administration for its partnered biosimilar candidate FYB201

Formycon AG has received a scientific advice letter from the U.S. Food and Drug Administration (FDA) regarding the preclinical and clinical development program for FYB201, the first biosimilar product candidate to emerge from its development pipeline, following the receipt of similarly favorable scientific advice from the European Medicines Agency (EMA) in December 2014.


Results announced for 1Q 2015, forecast raised for full-year 2015

In the first quarter of 2015, Formycon reported consolidated revenues of EUR 3.0 million. Based upon the recently announced successful signing of a partnership deal for FYB203, the company has raised its full-year forecast for fiscal year 2015, which it now expects to end with positive EBITDA.


Formycon AG signs licensing agreement for its FYB203 biosimilar

Under the agreement, Santo Holding will assume responsibility for, and the costs of, all further development activities, production and marketing of the Formycon biosimilar drug. Based on sales projections, the agreement is expected to yield Formycon total cumulative revenue well over the hundred million euro mark.


Carsten Brockmeyer belongs to the top 20 most influential people in the Global ‘Medicine Maker Power List’ 2015

He appears on the list alongside global leaders from the industry, including CEOs, Nobel Prize winners, and many other celebrated scientists from the pharmaceutical world.


Reappointment of board member Dr. Nicolas Combé

The Supervisory Board of Formycon AG has unanimously voted to extend the executive board appointment of Dr. Nicolas Combé, the co-founder of the company who has served with distinction as its chief financial officer since May 5, 2010.


Formycon AG successfully completes capital increase from approved capital

Proceeds from the share placement in the gross amount of EUR 11,115,960.00 will flow entirely to the company and are to be used to advance and expand the company’s biosimilar development programs in accordance with its plans, thus further strengthening the market position which Formycon has already achieved.


Formycon Group announces preliminary results for fiscal year 2014

Formycon AG has reported its preliminary consolidated financial results for fiscal year 2014, with sales revenue and other income totaling EUR 12.67 million (prior year: EUR 0.41 million). EBITDA for the year was EUR 1.94 million (prior year: - EUR 6.64 million), while net income came in at EUR 0.86 million (prior year: - EUR 7.74 million).


Formycon AG announces successful GMP inspection and the start of US FDA scientific advice procedure for its out-licensed biosimilar FYB201

This achievement is another important step in Formycon’s preparation of the pivotal phase III study of clinical testing for its first biosimilar candidate (FYB201).


Formycon AG moves planned start of pivotal phase III study for its first biosimilar product (FYB201) forward to 3Q 2015

For Formycon AG, the favorable response to its proposed plan for clinical studies means a significant shortening of its development and approval schedule.


Formycon AG releases nine-month figures for 2014

For the first nine months of 2014, the company posted revenues of EUR 8.98 million (2013: EUR 0.33 million). Its operating profitability likewise improved markedly, with EBITDA of EUR 2.64 million for the period from January through the end of September.


Formycon AG announces its results for the first half of 2014

In the first half of 2014, Formycon AG recorded a turnover of 7.4 million euros (2013: 0.2 million euros). The company's EBITDA amounted to 3.2 million euros in the first half of 2014 (first half of 2013: -3.0 million euros). Overall, the company expects to achieve positive EBITDA for the business year 2014.


Formycon AG commences development of its third product, seeing this as confirmation of its pioneering position in the “third wave” of biosimilar drugs

These products will be part of the so-called “third wave” of biosimilars, referring to the major, multi-billion-dollar blockbuster drugs created through biotechnology for indications in the areas of ophthalmology, autoimmune...


Formycon AG announces financial results of fiscal year 2013 and first quarter results of fiscal year 2014

For the first quarter of this year, Formycon AG has reported strong top-line and bottom-line growth, with revenue of EUR 5.832.904 compared to EUR 7.886 in the prior-year period.


Formycon AG: Strong partner increases marketing potential for the first biosimilar development project

Increased marketing potential for Formycon's first biosimilar FYB201 gives reason to expect a greater turnover share for Formycon.


Formycon AG appoints top US pharmaceuticals manager Bernhard Hampl to the Advisory Board

Over the past 20 years, Dr. Bernhard Hampl was a successful CEO in large American generics companies such as EON LABS Inc. and later Sandoz US, which after fusion of the two companies became America's second-largest manufacturer...


Formycon AG: Licensing out of the first biosimilar development project already enables extension of the product pipeline as of 2014

Formycon sets course for long-term alignment as a global biosimilar developer. Dr. Carsten Brockmeyer, one of the world's leading biosimilar experts, joined the board of directors. In addition Formycon appointed Dr. Gerhard Schaefer, former Head of Global Product and Business Development at Sandoz International, and Simon Sturge, previously Corporate Senior Vice President at Boehringer Ingelheim, to the advisory board.


Formycon AG signs first biosimilar licensing agreement with Santo Holding GmbH

Munich – Formycon AG today announced the signing of an exclusive, worldwide licensing agreement with Santo Holding GmbH, owned by the well noted German pharmaceutical investors Andreas and Thomas Strüngmann, granting rights to the first biosimilar drug of Formycon’s development pipeline.


Formycon AG successfully completes capital increase

Successful placement of shares among international institutional investores and family offices. The gross proceeds to the company of EUR 9,43 will be used to fund further product development activities.


Formycon AG today has announced the appointment of Gerhard Schaefer and Simon Sturge to Formycon’s Advisory Board

Gerhard Schaefer graduated with a Ph.D. in Chemistry from Stuttgart University. During his more than 30 years in the generic pharmaceutical industry, he held increasing senior management positions in development, quality assurance / control and business development at Azupharma, Knoll, Stada, HEXAL and Sandoz.