NANOHALE AG (FRA:FYB) EQS-Adhoc: FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)
Transparency directive : regulatory news
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EQS-Ad-hoc: Formycon AG / Key word(s): Regulatory Approval 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/OtulfiTM1 (ustekinumab-aauz), a biosimilar to Stelara®2. FYB202/OtulfiTM obtained FDA approval for the treatment of patients with Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis and active psoriatic arthritis. The approval for FYB202/OtulfiTM is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/OtulfiTM demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). 1) OtulfiTM is a Trademark of Fresenius Kabi Deutschland GmbH in selected countries
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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
27-Sep-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| 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: | 1997803 |
| End of Announcement | EQS News Service |
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1997803 27-Sep-2024 CET/CEST
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