SimianX AI LogoSimianX AI

原始出處紀錄

決策級FDA 核准

默沙東獲得 FDA 核准 IDVYNSO 用於病毒學抑制 HIV-1 患者

文件指出，默沙東獲得美國 FDA 核准 IDVYNSO，這是一種每日一次口服藥物，用於治療特定病毒學抑制的 HIV-1 成年患者。此項核准標誌著默沙東 HIV 產品線的新里程碑，並擴大其在傳染病領域的核准組合。此項核准被視為已完成的監管成果，未提及進一步的 PDUFA 或諮詢委員會日期。

關鍵事實

申報時間
2026年4月30日 上午10:53
事件
FDA 核准
方向
正面
公司
MRK默沙東
資產
IDVYNSO
來源
SEC 8-K
可信度
有出處
participants 65 plus
81 (11%)
participants 75 plus
10 (1%)
trial 051 suppression
96% vs 92%
trial 052 suppression
92% vs 94%
trial 051 hiv rna ge 50
1% vs 5% (IDVYNSO vs bART)
trial 052 hiv rna ge 50
1% vs 1% (IDVYNSO vs BIC/FTC/TAF)

來源摘錄

EX-99.1 2 tm2612241d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 News Release Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical Milestones Sales Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches - Total Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX) o KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $128 Million o WINREVAIR Sales Were $525 Million (88% Growth; 87% Growth ex-FX) o Animal Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX) - GAAP Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share Include a Ch

SEC 8-K

此資產的更多資訊