Zurück geht es hier Grüezi! Sie wurden auf finanzen.ch, unser Portal für Schweizer Anleger, weitergeleitet.  Zurück geht es hier.
10.07.2025 06:30:03

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
Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206

10.07.2025 / 06:30 CET/CEST
The issuer is solely responsible for the content of this announcement.


Press Release // July 10, 2025

 

Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206
 

  • Streamlined clinical development program, which no longer requires a Phase III trial, is already in a far advanced stage
  • Last patient enrolled in Dahlia pharmacokinetic (PK) study (Last Patient-In)
  • First patients have completed all 17 treatment cycles of the Dahlia study
  • Results on the primary endpoint of the study expected in the first quarter of 2026
  • Formycon's position in the leading group of Keytruda® biosimilar developers confirmed
     

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.
2  Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
3  Source: https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/
4 Source: https://www.custommarketinsights.com/report/keytruda-market/
5 Source: https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services

 

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

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:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com 

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.



10.07.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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

Analysen zu Formycon AG

  • Alle
  • Kaufen
  • Hold
  • Verkaufen
  • ?
10.07.25 Formycon Outperform RBC Capital Markets
27.06.25 Formycon Buy Hauck Aufhäuser Lampe Privatbank AG
26.06.25 Formycon Buy Warburg Research
25.06.25 Formycon Outperform RBC Capital Markets
17.06.25 Formycon Buy Warburg Research
Eintrag hinzufügen

Erfolgreich hinzugefügt!. Zu Portfolio/Watchlist wechseln.

Es ist ein Fehler aufgetreten!

Kein Portfolio vorhanden. Bitte zusätzlich den Namen des neuen Portfolios angeben. Keine Watchlisten vorhanden. Bitte zusätzlich den Namen der neuen Watchlist angeben.

CHF
Hinzufügen

«Gold, kein Bonds!» – Thomas Wille über die richtige Strategie – zu Gast im BX Morningcall mit François Bloch

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.

Im aktuellen BX Morningcall begrüssen wir Investment Stratege François Bloch und David Kunz, COO der BX Swiss, Thomas Wille. Sie sprechen über die Bedeutung massgeschneiderter Investmentlösungen, den wachsenden Stellenwert alternativer Anlageklassen wie Gold, Private Markets und Krypto, sowie über die Herausforderungen in einem dynamischen Marktumfeld. Thomas Wille gibt Einblicke in seine Sicht auf die aktuelle Marktlage, seine Einschätzung zu Zinsen, Inflation, USD vs CHF – und er verrät, wie er persönlich investiert.

Ausserdem: Welche Rolle spielt Digitalisierung in der Vermögensverwaltung? Und welche Prinzipien sind heute entscheidend, um in der Vermögensverwaltung erfolgreich zu sein?

👉🏽 https://bxplus.ch/bx-musterportfolio/

«Gold, kein Bonds!» – Thomas Wille über die richtige Strategie – zu Gast im BX Morningcall mit François Bloch

Mini-Futures auf SMI

Typ Stop-Loss Hebel Symbol
Short 12’599.15 19.21 B0LSNU
Short 12’851.50 13.91 UUOSMU
Short 13’335.26 8.90 JZUBSU
SMI-Kurs: 12’033.64 11.07.2025 09:15:53
Long 11’584.93 19.21 B1FSHU
Long 11’338.96 13.91 BZDS0U
Long 10’845.13 8.90 BPOSGU
Die Produktdokumentation, d.h. der Prospekt und das Basisinformationsblatt (BIB), sowie Informationen zu Chancen und Risiken, finden Sie unter: https://keyinvest-ch.ubs.com

finanzen.net News

Datum Titel
{{ARTIKEL.NEWS.HEAD.DATUM | date : "HH:mm" }}
{{ARTIKEL.NEWS.BODY.TITEL}}