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10.07.2025 06:30:03
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EQS-News: Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206
EQS-News: Formycon AG
/ Key word(s): Study
Press Release // July 10, 2025
Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the patient enrollment for the clinical PK study Dahlia1 has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda®2. At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda® based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda® outside the trial. „With our streamlined clinical development program for FYB206, we have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The fact that we can now announce the completion of patient enrollement with the ‘last patient in’ is further proof of Formycon's professional study management and the strong recruitment performance in the study centers“, says Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG and adds: „The first patients in the Dahlia trial have already completed all 17 treatment cycles. We therefore currently expect to receive the results of the study endpoint in the first quarter of 2026. As a reminder: based on our stringent Dahlia study design, our sound scientific rationale and the comprehensive analytical data showing high structural and functional comparability with the reference drug, we have aligned with the FDA on a streamlined clinical development program that allows us to skip the Phase III trial. This approach accelerates development without compromising on quality, safety and efficacy. Furthermore – the streamlined clinical program supports our strategy to provide the pembrolizumab biosimilar FYB206 to patients worldwide as soon as possible and thus improve access to this essential drug.“ Pembrolizumab is an immune checkpoint inhibitor that is used in cancer therapies to treat various tumor diseases. With this broad range of indications and sales of around US$ 29.5 billion in 20243, Keytruda® is currently the world's best-selling drug. Sales could rise even further in the coming years – according to forecasts to over US$ 50 billion in 20324. The number of cancer diagnoses is also continuing to rise – estimates by the International Agency for Research on Cancer (IARC) predict an increase of 77% by 2050.5 Following the successful completion of clinical development and approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and after 2030 for the EU. -------------------- 1 The Dahlia-PK study treats patients who have had malignant melanoma (black skin cancer) surgically removed. This so-called adjuvant therapy over 17 treatment cycles aims to minimize the risk of relapse in these patients.
About Formycon: Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDax selection indices. Further information can be found at: https://www.formycon.com/ About Biosimilars: Contact: phone +49 (0) 89 - 86 46 67 149 Disclaimer:
10.07.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. |
Language: | English |
Company: | Formycon AG |
Fraunhoferstraße 15 | |
82152 Planegg-Martinsried | |
Germany | |
Phone: | 089 864667 100 |
Fax: | 089 864667 110 |
Internet: | www.formycon.com |
ISIN: | DE000A1EWVY8 |
WKN: | A1EWVY |
Indices: | SDAX, TecDAX |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
EQS News ID: | 2167676 |
End of News | EQS News Service |
|
2167676 10.07.2025 CET/CEST
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Thomas Wille, Chief Investment Officer bei Copernicus Wealth Management, ist seit über drei Jahrzehnten an den globalen Kapitalmärkten aktiv. Im exklusiven Interview mit dem BX Morning Call spricht er über seine Erfahrungen durch Finanzkrisen, neue Marktzyklen und die Kunst, Anlagestrategien langfristig erfolgreich umzusetzen.
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