from Nanohale AG (isin : DE000A1EWVY8)
EQS-Adhoc: FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)
EQS-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)
28-Jun-2024 / 23:50 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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 the treatment of patients with neovascular Age-Related (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO).
The approval for FYB203/AHZANTIVE® is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203/AHZANTIVE® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eylea® in patients with neovascular Age-Related (wet) Macular Degeneration (nAMD).
1) Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.
2) AHZANTIVE® is a registered Trademark of Klinge Biopharma GmbH
Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
phone +49 (0) 89 – 86 46 67 149 | fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com
Disclaimer
Certain statements contained in this release may constitute "forward-looking statements" that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words "may," "will," "should," "plan," "expect," "anticipate," "estimate," "believe," "intend," "project," or "aim," or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change.
Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review, revise or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation.
End of Inside Information
28-Jun-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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| 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: | Scale 30 |
| Listed: | Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 1936195 |
| End of Announcement | EQS News Service |
1936195 28-Jun-2024 CET/CEST