Formycon AG · ISIN: DE000A1EWVY8 · EQS - adhoc news

FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb) Planegg-Martinsried, Germany, 28. June 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH ("Klinge") announce that the U.S. Food and Drug Administration ("FDA") today approved FYB203/AHZANTIVE® (aflibercept-mrbb), a biosimilar to Eylea®. FYB203/AHZANTIVE® obtained FDA approval for t...

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28 June 2024 11:50PM
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb) Planegg-Martinsried, Germany, 28. June 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH ("Klinge") announce that the U.S. Food and D...
Formycon AG
28 June 2024 11:50PM
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb) Planegg-Martinsried, Germany, 28. June 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH ("Klinge") announce that the U.S. Food and D...
Formycon AG
13 June 2024 07:31AM
Formycon starts clinical development program for FYB206, a biosimilar candidate for immuno-oncology blockbuster drug Keytruda
Press Release // June 13, 2024 Formycon starts clinical development program for FYB206, a biosimilar candidate for immuno-oncology blockbuster drug Keytruda First patient entered Phase I clinical trial “Dahlia” to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda®[i] (First Patient In). "Dah...
Formycon AG
08 May 2024 07:30AM
Formycon reports on successful operating business and financial figures for the first quarter of 2024
Press Release // May 8, 2024 Formycon reports on successful operating business and financial figures for the first quarter of 2024  Group revenue amounts to € 17.7 million and corresponds to plan Group EBITDA of € -5.5 million reflects investments in pipeline and corporate development Adjusted Group EBITDA of € -1.2 million shows strong at-equi...
Formycon AG
07 May 2024 11:00AM
Formycon invites to the Annual General Meeting on June 12, 2024 in Munich
Press release // 07 May 2024 Formycon invites to the Annual General Meeting on June 12, 2024 in Munich Formycon proposes to the Annual General Meeting a more international focus and expansion of the Supervisory Board to five members With Colin Bond, Dr. Bodo Coldewey and Nicholas Haggar, three new candidates with relevant industry and financial...
Formycon AG
02 May 2024 07:30AM
Formycon hosts conference call on the results of the first quarter 2024
Press Release // May 02, 2024 Formycon hosts conference call on the results of the first quarter 2024 Planegg-Martinsried – Formycon AG (FWB: FYB, 'Formycon') today announced details of the conference call to release the results of the first quarter 2024 on May 08, 2024. The management board will discuss the company's developments and key financi...
Formycon AG
25 April 2024 07:30AM
Formycon reports audited annual results for the financial year 2023 – Looking back on a successful operative year and exceeded guidance
Press release // April 25, 2024 Formycon reports audited annual results for the financial year 2023 – Looking back on a successful operative year and exceeded guidance Preliminary results 2023 confirmed Group revenue increases by 83% compared to the previous year to a total of € 77.7 million Positive Group EBITDA of around € 1.5 million and adj...
Formycon AG
12 April 2024 10:15PM
Convincing overall performance - Formycon reports preliminary results for the financial year 2023 and exceeds forecast
Press release // 12 April 2024   Convincing overall performance - Formycon reports preliminary results for the financial year 2023 and exceeds forecast   Group revenue increase by 83% compared to the previous year to a total of € 77.7 million Positive Group EBITDA of around € 1.5 million achieved New key financial performance indicator (KPI) "...
Formycon AG
12 April 2024 07:27PM
Formycon AG publishes preliminary figures for the 2023 financial year and guidance for the 2024 financial year
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 Formycon AG publishes preliminary figures for the 2023 financial year and guidance for the 2024 financial year Planegg-Martinsried, Germany, 12. April 2024 – Based on preliminary and unaudited figures for the 2023 financial year, Formycon AG (ISIN: DE000A1...
Formycon AG
11 April 2024 07:30AM
Formycon announces commercial launch of FYB201 (Ranibizumab) in Canada (RanoptoTM) and Switzerland (Ranivisio®)
Press release // April 11, 2024   Formycon announces commercial launch of FYB201 (Ranibizumab) in Canada (RanoptoTM) and Switzerland (Ranivisio®)   Commercial launch opens up additional key markets in Europe and North America, making FYB201 available in a total of 17 countries worldwide Lucentis® biosimilar FYB201 is an effective and cost-effi...
Formycon AG
18 March 2024 10:00AM
Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada
Press release // March 18, 2024   Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada   Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the comme...
Formycon AG
11 March 2024 07:30AM
FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region
Press release // March 11, 2024   FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region Commercialization partner MS Pharma wins government tender for Ranibizumab in Saudi Arabia Commercial launch of FYB201/Ravegza® planned for second quarter of 2024 Further launches planned throughout 2024 to improve access ...
Formycon AG
29 January 2024 10:15PM
Gedeon Richter becomes strategic investor of Formycon via equity investment
Press Release // January 29, 2024 Gedeon Richter becomes strategic investor of Formycon via equity investment Already established trustful collaboration in contract development and manufacturing results in investment through takeover of 9.08% of shares via cash capital increase Gross-proceeds in the amount of EUR 82.84 million to maintain Formyc...
Formycon AG
29 January 2024 10:10PM
Formycon resolves on cash capital increase of EUR 82.84 million – all new shares were subscribed by Gedeon Richter as new strategic investor
NOT FOR DISTRIBUTION, PUBLICATION OR TRANSMISSION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION WHERE SUCH DISTRIBUTION, PUBLICATION OR TRANSMISSION WOULD BE UNLAWFUL. FURTHER RESTRICTIONS APPLY. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT. Disclosure of i...
Formycon AG
18 January 2024 07:30AM
Formycon Ranibizumab Biosimilar FYB201/CIMERLI® achieved a market share of 38% in the United States in December 2023
Press Release // January 18, 2024   Formycon Ranibizumab Biosimilar FYB201/CIMERLI® achieved a market share of 38% in the United States in December 2023   Munich, Germany – Formycon AG (FWB: FYB) today announced that its commercialization partner, Coherus BioSciences, Inc. has released new sales figures for CIMERLI®1 (Ranibizumab-eqrn) in the US...
Formycon AG
04 January 2024 05:06PM
Formycon to present at the 42nd Annual J.P. Morgan Healthcare Conference
Press Release // January 04, 2024   Formycon to present at the 42nd Annual J.P. Morgan Healthcare Conference Munich, Germany – Formycon AG (FSE: FYB), a leading, independent developer of high-quality biosimilars, today announced that Formycon CEO Dr. Stefan Glombitza will present at the upcoming 42nd Annual J.P. Morgan Healthcare Conference on T...
Formycon AG
27 December 2023 07:30AM
Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
Press Release // December 27, 2023   Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea®(Aflibercept) Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization ap...
Formycon AG
07 December 2023 07:30AM
Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis®
Press Release // December 07, 2023   Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis® Munich, Amsterdam, Zug, Toronto – 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®1 (Ranibizumab), a biosimilar ...
Formycon AG
05 December 2023 07:30AM
Formycon announces participation in international Investor Conferences in Q1/2024
Press Release // December 05, 2023    Formycon announces participation in international Investor Conferences in Q1/2024   Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that members of the Management Board plan to be present at the following investor conferences in the first quarter of 2024:   J.P. Morgan Hea...
Formycon AG
30 November 2023 07:30AM
Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
Press Release // November 30, 2023   Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Adminis...
Formycon AG
27 November 2023 07:30AM
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
Press Release // November 27, 2023   Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)   Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eyle...
Formycon AG
13 November 2023 07:30AM
Formycon publishes nine-month results for 2023
Press release // November 13, 2023 Formycon publishes nine-month results for 2023 Development of the biosimilar portfolio is progressing according to plan – further news flow expected by the end of 2023 More than 200,000 doses of FYB201 now administered to patients worldwide Group revenue rises to a total of € 60.2 million (Q3/2022: € 28.2 mil...
Formycon AG
10 November 2023 06:30AM
Formycon hosts conference call on nine-month figures 2023 and presents at further investor conferences
Press Release // November 10, 2023 Formycon hosts conference call on nine-month figures 2023 and presents at further investor conferences Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) 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 ...
Formycon AG
10 October 2023 07:30AM
Formycon Ranibizumab Biosimilar FYB201/CIMERLI®1 achieved 25% market share2 in the United States
Press Release // October 10, 2023 Formycon Ranibizumab Biosimilar FYB201/CIMERLI®1 achieved 25% market share2 in the United States Munich – 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 si...
Formycon AG
29 September 2023 07:30AM
Formycon and Fresenius Kabi announce European Medicines Agency Submission Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate
Press Release // September 29, 2023 Formycon and Fresenius Kabi announce European Medicines Agency Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the European Medicines...
Formycon AG
30 August 2023 07:30AM
Formycon reports successful first half of 2023
Press Release // August 30, 2023 Formycon reports successful first half of 2023 Development of biosimilar candidates proceeds successfully and according to plan € 43.8 million represent highest group revenue in Formycon’s history (+148%) partly due to significant success payments for FYB202 as well as participation in the marketing proceeds of F...
Formycon AG
29 August 2023 07:30AM
Formycon announces File Acceptance for FYB203, a biosimilar candidate to Eylea®1 (aflibercept), by the U.S. Food and Drug Administration (FDA)
Press Release // August 29, 2023 Formycon announces File Acceptance for FYB203, a biosimilar candidate to Eylea®1 (aflibercept), by the U.S. Food and Drug Administration (FDA) Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the U.S. Food and Drug Administration (“FDA”) ...
Formycon AG
23 August 2023 07:30AM
Formycon hosts conference call on financial and earnings position for H1 2023
  Press Release // August 23, 2023   Formycon hosts conference call on financial and earnings position for H1 2023 Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced details of its financial and earnings conference call for the first half of 2023. Following the publication of the half-year report 2023 in the morning of Augus...
Formycon AG
07 August 2023 08:00AM
Formycon and Fresenius Kabi secure U.S. License Date for proposed Ustekinumab Biosimilar
Press Release // August 7, 2023 Formycon and Fresenius Kabi secure U.S. License Date for proposed Ustekinumab Biosimilar Formycon and Fresenius Kabi entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed ustekinumab biosimilar in the U.S. As per the settlement, FYB202 can be marketed in the U.S., subject to ...
Formycon AG
26 July 2023 07:30AM
Formycon reports on the regular Annual General Meeting
Press release // July 26, 2023 Formycon reports on the regular Annual General Meeting Shareholders approve all agenda items Management board and supervisory board ratified by large majority Wolfgang Essler elected as a new member to the supervisory board Comprehensive reporting by the management on company development Munich - On July 25, 2023...
Formycon AG
26 July 2023 07:30AM
Formycon reports on the regular Annual General Meeting
Press release // July 26, 2023 Formycon reports on the regular Annual General Meeting Shareholders approve all agenda items Management board and supervisory board ratified by large majority Wolfgang Essler elected as a new member to the supervisory board Comprehensive reporting by the management on company development Munich - On July 25, 2023...
Formycon AG
29 June 2023 07:30AM
Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)
 Press Release // June 29, 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) Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics lic...
Formycon AG
29 June 2023 07:30AM
Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)
 Press Release // June 29, 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) Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics lic...
Formycon AG
30 May 2023 07:30AM
Formycon reports results for the first quarter 2023
Press Release // May 30, 2023 Formycon reports results for the first quarter 2023 Group revenues amount to Euro 21.5 million (Q1/2022: Euro 8.1 million) and include, in addition to a significant milestone payment for the successful global partnering of FYB202, revenue contributions from the commercialization of FYB201 Group EBITDA of Euro 4.5 m...
Formycon AG
30 May 2023 07:30AM
Formycon reports results for the first quarter 2023
Press Release // May 30, 2023 Formycon reports results for the first quarter 2023 Group revenues amount to Euro 21.5 million (Q1/2022: Euro 8.1 million) and include, in addition to a significant milestone payment for the successful global partnering of FYB202, revenue contributions from the commercialization of FYB201 Group EBITDA of Euro 4.5 m...
Formycon AG
10 May 2023 07:30AM
Formycon Announces Participation in International Investor Conferences in Q2/2023
Press Release // May 10, 2023 Formycon Announces Participation in International Investor Conferences in Q2/2023 Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that members of the Management Board will present at the following investor conferences in the second quarter of 2023: Equity Forum – Spring Conference ...
Formycon AG
10 May 2023 07:30AM
Formycon Announces Participation in International Investor Conferences in Q2/2023
Press Release // May 10, 2023 Formycon Announces Participation in International Investor Conferences in Q2/2023 Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that members of the Management Board will present at the following investor conferences in the second quarter of 2023: Equity Forum – Spring Conference ...
Formycon AG
27 April 2023 07:30AM
Formycon publishes results for financial year 2022
Press Release // April 27, 2023 Formycon publishes results for financial year 2022 Approval and commercial launch of FYB201 as well as ATHOS transaction mark transformative fiscal year Group revenues increase to Euro 42.5 million (2021 IFRS: Euro 36.6 million) and include first earning contributions from commercialization of FYB201 EBITDA of Eu...
Formycon AG
27 April 2023 07:30AM
Formycon publishes results for financial year 2022
Press Release // April 27, 2023 Formycon publishes results for financial year 2022 Approval and commercial launch of FYB201 as well as ATHOS transaction mark transformative fiscal year Group revenues increase to Euro 42.5 million (2021 IFRS: Euro 36.6 million) and include first earning contributions from commercialization of FYB201 EBITDA of Eu...
Formycon AG
25 April 2023 07:00AM
Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development
Press Release // April 25, 2023 Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development Positive data from extended Phase I pharmacokinetics study complete clinical development program Phase I and phase III clinical trial program demonstrated comparable safety...
Formycon AG
25 April 2023 07:00AM
Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development
Press Release // April 25, 2023 Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development Positive data from extended Phase I pharmacokinetics study complete clinical development program Phase I and phase III clinical trial program demonstrated comparable safety...
Formycon AG
07 February 2023 07:30AM
Enno Spillner appointed Chief Financial Officer (CFO) of Formycon AG
Press Release // February 7, 2023    Enno Spillner appointed Chief Financial Officer (CFO) of Formycon AG Munich, Germany - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) 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. ...
Formycon AG
07 February 2023 07:30AM
Enno Spillner appointed Chief Financial Officer (CFO) of Formycon AG
Press Release // February 7, 2023    Enno Spillner appointed Chief Financial Officer (CFO) of Formycon AG Munich, Germany - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) 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. ...
Formycon AG
06 February 2023 07:30AM
Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study
Press Release // February 6, 2023 Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study MAGELLAN-AMD study demonstrates the comparable efficacy of FYB203 to the reference product Eylea® in patients with neovascular age-related macular degeneration (nAMD) Primary efficacy endpoint fo...
Formycon AG
06 February 2023 07:30AM
Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study
Press Release // February 6, 2023 Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study MAGELLAN-AMD study demonstrates the comparable efficacy of FYB203 to the reference product Eylea® in patients with neovascular age-related macular degeneration (nAMD) Primary efficacy endpoint fo...
Formycon AG
02 February 2023 08:00AM
Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Press Release February 2, 2023 Formycon and Fresenius Kabi conclude global commercialization partnership 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), announced...
Formycon AG
02 February 2023 08:00AM
Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Press Release February 2, 2023 Formycon and Fresenius Kabi conclude global commercialization partnership 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), announced...
Formycon AG
02 February 2023 07:30AM
Formycon AG announces result of private placement and sets placement price for the new shares from the capital increase
NOT FOR DISTRIBUTION, PUBLICATION OR TRANSMISSION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION WHERE SUCH DISTRIBUTION, PUBLICATION OR TRANSMISSION WOULD BE UNLAWFUL. FURTHER RESTRICTIONS APPLY. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS PUBLICATION.Publication of ins...
Formycon AG
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