一次情報の記録

決定級FDA 承認

Viatris: FDAがGwyn Lo(ノルエルゲストロミン/エチニルエストラジオールパッチ)を承認

FDAが新しい低用量配合ホルモン避妊パッチであるGwyn Loを承認しました。本製品は今年後半に市販される予定で、Viatrisのポートフォリオに新しいブランド製品が加わります。

主要事実

提出
2026年8月6日 11:56
イベント
FDA 承認
方向
ポジティブ
出典
SEC 8-K
信頼度
出典あり

出典の抜粋

EX-99.1 2 exhibit991-2q26earningsrel.htm EX-99.1 Document Viatris Reports Second-Quarter 2026 Financial Results • Delivers Total Revenues of $3.8 Billion, Representing 5% Reported Growth Compared to Second Quarter 2025 and a U.S. GAAP Net Loss of $119 Million • Total Revenues Were Up 3.5% Operationally Compared to Second Quarter 2025 • Adjusted EBITDA was $1.2 Billion, Up 8% Operationally Compared to Second Quarter 2025 • Advances Key Pipeline Milestones, Including U.S. FDA Approval of Gwyn Lo TM • Announces Sale of Global Rights to Tyrvaya ® • Returns Approximately $550 Million of Capital to Shareholders, Including Through Share Repurchases; Reduces Gross Leverage Ratio to 2.9x • Raises 2026 Financial Guidance Midpoints for All Metrics [1] PITTSBURGH – August 6, 2026 – Viatris I

SEC 8-K