メルク、KEYTRUDA QLEX皮下注射剤のFDA承認を取得

The document states that Merck received FDA approval for KEYTRUDA QLEX Injection for subcutaneous use across all solid tumor indications for KEYTRUDA. This converts an existing intravenous biologic into a subcutaneous formulation, expanding the delivery options for the same asset without altering the approved indications.

主要事実

提出: 2025年10月30日 10:40
イベント: FDA 承認
方向: ポジティブ
企業: MRKMSD
アセット: pembrolizumab
出典: SEC 8-K
信頼度: 出典あり
N: 1841
p: 0.0003
CI: 0.59-0.87
HR: 0.72
24mo DFS: 81% vs 74%

出典の抜粋

EX-99.1 2 tm2529620d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 - 1 - News Release Merck & Co., Inc., Rahway, N.J., USA Announces Third-Quarter 2025 Financial Results - Total Worldwide Sales Were $17.3 Billion, an Increase of 4% From Third Quarter 2024; Excluding the Impact of Foreign Exchange, Sales Grew 3% o KEYTRUDA Sales Grew 10% to $8.1 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 8% o WINREVAIR Sales Were $360 Million; Growth of 141% Both Nominally and Excluding the Impact of Foreign Exchange o CAPVAXIVE Sales Were $244 Million o GARDASIL/GARDASIL 9 Sales Declined 24% to $1.7 Billion; Excluding the Impact of Foreign Exchange, Sales Declined 25% o Animal Health Sales Grew 9% to $1.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 7% - GAAP EPS Was

SEC 8-K