Formycon AG · ISIN: DE000A1EWVY8 · EQS - adhoc news

Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014   Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA   Planegg-Martinsried, Germany, November 15, 2024 – Formycon (FSE: FYB, "Formycon“) announces that the European Medicines Agency (EMA) published today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for market approval for FYB203/ AHZANTIVE®1/ Baiama®2, a biosimilar cand...

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15 November 2024 06:18PM
Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014   Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA   Planegg-Martinsried, Germany, November 15, 2024 – Formycon (FSE: FYB, "Formycon“) announces that the European Medicines Agency (EMA) published today that the Co...
Formycon AG
11 November 2024 05:41PM
Formycon extends Management Board contract for CEO Dr. Stefan Glombitza until 2027 and receives admission to trading in the Prime Standard
Press Release // November 11, 2024Formycon extends Management Board contract for CEO Dr. Stefan Glombitza until 2027 and receives admission to trading in the Prime Standard  Dr. Stefan Glombitza has been appointed as CEO for three more years and will lead Formycon through the next phase of the company's development Formycon shares will be admitt...
Formycon AG
04 November 2024 06:30AM
Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange
Press Release // November 04, 2024 Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange Application for admission to trading on the regulated market (Prime Standard) of the Frankfurt Stock Exchange will be submitted today Trading of Formycon shares on the Prime Standard segment is expected to start on November 12,...
Formycon AG
16 October 2024 06:50AM
Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D
Press Release // October 16, 2024   Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D   The comparative analytical evaluation results indicate that the proposed Keytruda®-biosimilar FYB206 is structurally and functionally highly similar to the reference...
Formycon AG
30 September 2024 07:30AM
Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)
Press Release // September 30, 2024 Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz) OtulfiTMreceived FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara®   Approval represents the third successful FDA approval for a Formycon biosimilar, two of them in ...
Formycon AG
27 September 2024 09:56PM
FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz) Planegg-Martinsried, Germany, September 27, 2024 – Formycon AG (FSE: FYB, "Formycon“) announces that the U.S. Food and Drug Administration (“FDA”) today approved FYB202/OtulfiTM...
Formycon AG
27 September 2024 09:00AM
Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases
Press Release // September 27, 2024Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases FYB202/Otulfi® received European Commission (EC) approval for both subcutaneous and intravenous formulations, providing a high-quality treatment option for European...
Formycon AG
17 September 2024 06:50AM
Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna
Press Release // September 17, 2024  Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna   Planegg-Martinsried – Formycon AG (FWB: FYB) will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year's European Academy of Derma...
Formycon AG
17 September 2024 06:50AM
Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna
Press Release // September 17, 2024  Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna   Planegg-Martinsried – Formycon AG (FWB: FYB) will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year's European Academy of Derma...
Formycon AG
13 August 2024 06:50AM
Formycon reports a strong first half-year with multiple milestones achieved
Press Release // August 13, 2024 Formycon reports a strong first half-year with multiple milestones achieved Successful business development characterized by key operational, clinical, and regulatory milestones Group revenue and EBITDA in line with expectations Operating results of FYB201 in the first half of the year significantly exceeded ex...
Formycon AG
07 August 2024 06:50AM
Formycon invites to conference call on 2024 half-year results and announces participation in international investor conferences
Press Release // August 7, 2024   Formycon invites to conference call on 2024 half-year results and announces participation in international investor conferences   Planegg-Martinsried, Germany – Formycon AG (FWB: FYB) today announced details for the financial and earnings conference call for the first half of the 2024 fiscal year on August 13, 2...
Formycon AG
06 August 2024 12:40PM
Formycon AG increases its outlook for the 2024 fiscal year
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 Formycon AG increases its outlook for the 2024 fiscal year Planegg-Martinsried, Germany, August 06, 2024 – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Company”) has today decided, based on the preliminary half-year figures, to raise its guidance for t...
Formycon AG
30 July 2024 06:50AM
Formycon announces start of clinical phase III trial for Keytruda® biosimilar candidate FYB206
Press Release // July 30, 2024   Formycon announces start of clinical phase III trial for Keytruda® biosimilar candidate FYB206  Phase III “Lotus” trial compares safety and efficacy of FYB206 with reference drug Keytruda®1 (pembrolizumab) The “Lotus” trial will involve the treatment of around 500 randomized NSCLC2 patients in various countries ...
Formycon AG
26 July 2024 12:00PM
Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara®
Press Release // July 26, 2024   Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara®   Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of FYB202 for the treatment of severe inflammatory diseases in the fields of gastroente...
Formycon AG
26 July 2024 10:54AM
Stelara® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014 Stelara® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA Planegg-Martinsried, Germany, July 26, 2024 – Formycon AG (FSE: FYB, "Formycon“) announces that the Committee for Medicinal Products for Human Use („CHMP“) of the Eu...
Formycon AG
01 July 2024 06:50AM
Formycon receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a biosimilar to Eylea®2)
Press Release // July 01, 2024   Formycon receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a biosimilar to Eylea®2)   Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH ("Klinge") jointly announce that the U.S. Food and Drug Administration ("FDA") approved FYB203/AHZA...
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
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 03:30PM
Formycon reports on the results of the Annual General Meeting
Press Release // June 13, 2024 Formycon reports on the results of the Annual General Meeting Management provides detailed report on financial year 2023 and current company performance Shareholders approve all agenda items and formally approve the acts of the members of the Management Board and Supervisory Board by large majority Supervisory Boa...
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
15 May 2024 07:30AM
MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region
Presse Release // May 15, 2024   MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region   Planegg-Martinsried – Klinge Biopharma GmbH ("Klinge"), licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon's biosimilar candidate to...
Formycon AG
15 May 2024 07:30AM
MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region
Presse Release // May 15, 2024   MS Pharma becomes Partner for the Commercialization of FYB203, Formycon’s Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region   Planegg-Martinsried – Klinge Biopharma GmbH ("Klinge"), licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon's biosimilar candidate to...
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
22 April 2024 07:30AM
Formycon invites to the conference call on the results of the financial year 2023 and announces participation in international investor conferences in the 2nd quarter of 2024
Press Release // April 22, 2024   Formycon invites to the conference call on the results of the financial year 2023 and announces participation in international investor conferences in the 2nd quarter of 2024   Munich - Formycon AG (FWB: FYB, 'Formycon') today announced details of the conference call to release the results of the financial year 2...
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
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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
More Formycon AG related information
Type Total Last Made by Go to
Corporate Research 17 1st October 2024 EQS Group AG Corporate Research
Directors Dealings 4 30th April 2024 Mikulcik, Dr. Marc DD
Short Seller (DE) 0 - - SSR (DE)
Short Seller (UK) 0 - - SSR (UK)
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