Formycon AG · ISIN: DE000A1EWVY8 · EQS - Company News

Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®

Press Release // November 18, 2024   Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama® Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of FYB203 for the treatment of Neovascular Age-Related Macular Degeneration (nAMD), along with several other serious retinal diseases Approval decision by the European Commission expected in the second ha...

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18 November 2024 06:30AM
Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®
DE000A1EWVY8
Press Release // November 18, 2024   Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama® Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of FYB203 for the treatment of Neovascular Age-Related ...
Formycon AG
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15 November 2024 06:18PM
Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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04 November 2024 06:30AM
Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange
DE000A1EWVY8
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,...
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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
DE000A1EWVY8
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...
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30 September 2024 07:30AM
Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)
DE000A1EWVY8
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 ...
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27 September 2024 09:56PM
FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)
DE000A1EWVY8
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...
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27 September 2024 09:00AM
Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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13 August 2024 06:50AM
Formycon reports a strong first half-year with multiple milestones achieved
DE000A1EWVY8
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...
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07 August 2024 06:50AM
Formycon invites to conference call on 2024 half-year results and announces participation in international investor conferences
DE000A1EWVY8
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...
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06 August 2024 12:40PM
Formycon AG increases its outlook for the 2024 fiscal year
DE000A1EWVY8
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...
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30 July 2024 06:50AM
Formycon announces start of clinical phase III trial for Keytruda® biosimilar candidate FYB206
DE000A1EWVY8
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 ...
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26 July 2024 12:00PM
Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara®
DE000A1EWVY8
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...
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26 July 2024 10:54AM
Stelara® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA
DE000A1EWVY8
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...
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01 July 2024 06:50AM
Formycon receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a biosimilar to Eylea®2)
DE000A1EWVY8
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...
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28 June 2024 11:50PM
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)
DE000A1EWVY8
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...
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28 June 2024 11:50PM
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)
DE000A1EWVY8
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...
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13 June 2024 03:30PM
Formycon reports on the results of the Annual General Meeting
DE000A1EWVY8
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...
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13 June 2024 07:31AM
Formycon starts clinical development program for FYB206, a biosimilar candidate for immuno-oncology blockbuster drug Keytruda
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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08 May 2024 07:30AM
Formycon reports on successful operating business and financial figures for the first quarter of 2024
DE000A1EWVY8
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...
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07 May 2024 11:00AM
Formycon invites to the Annual General Meeting on June 12, 2024 in Munich
DE000A1EWVY8
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...
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02 May 2024 07:30AM
Formycon hosts conference call on the results of the first quarter 2024
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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12 April 2024 10:15PM
Convincing overall performance - Formycon reports preliminary results for the financial year 2023 and exceeds forecast
DE000A1EWVY8
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) "...
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12 April 2024 07:27PM
Formycon AG publishes preliminary figures for the 2023 financial year and guidance for the 2024 financial year
DE000A1EWVY8
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...
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11 April 2024 07:30AM
Formycon announces commercial launch of FYB201 (Ranibizumab) in Canada (RanoptoTM) and Switzerland (Ranivisio®)
DE000A1EWVY8
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...
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18 March 2024 10:00AM
Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada
DE000A1EWVY8
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...
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11 March 2024 07:30AM
FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region
DE000A1EWVY8
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 ...
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29 January 2024 10:15PM
Gedeon Richter becomes strategic investor of Formycon via equity investment
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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18 January 2024 07:30AM
Formycon Ranibizumab Biosimilar FYB201/CIMERLI® achieved a market share of 38% in the United States in December 2023
DE000A1EWVY8
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...
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04 January 2024 05:06PM
Formycon to present at the 42nd Annual J.P. Morgan Healthcare Conference
DE000A1EWVY8
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...
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27 December 2023 07:30AM
Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
DE000A1EWVY8
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...
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07 December 2023 07:30AM
Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis®
DE000A1EWVY8
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 ...
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05 December 2023 07:30AM
Formycon announces participation in international Investor Conferences in Q1/2024
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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27 November 2023 07:30AM
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept)
DE000A1EWVY8
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...
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13 November 2023 07:30AM
Formycon publishes nine-month results for 2023
DE000A1EWVY8
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...
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10 November 2023 06:30AM
Formycon hosts conference call on nine-month figures 2023 and presents at further investor conferences
DE000A1EWVY8
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 ...
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10 October 2023 07:30AM
Formycon Ranibizumab Biosimilar FYB201/CIMERLI®1 achieved 25% market share2 in the United States
DE000A1EWVY8
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...
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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
DE000A1EWVY8
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...
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30 August 2023 07:30AM
Formycon reports successful first half of 2023
DE000A1EWVY8
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...
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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)
DE000A1EWVY8
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”) ...
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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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