Intellia: FDA chấp nhận BLA cho lonvo-z (HAE) với Đánh giá Ưu tiên; PDUFA 10 Mar 2027

Trích đoạn nguồn

EX-99.1 2 ntla-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE) • FDA sets Prescription Drug User Fee Act (PDUFA) date of March 10, 2027 • Positions lonvo-z to be the world’s first in vivo CRISPR-based therapy and the only one-time HAE treatment, if approved CAMBRIDGE, Mass., September 8, 2026 -- Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review

SEC 8-K

Thêm về tài sản này

Mang tính quyết định

15 thg 6, 2026

12:52

NTLAIntellia

Intellia báo cáo kết quả tích cực từ giai đoạn 3 HAELO cho lonvo-z trong HAE

Kết quả toplineSEC 8-KMở hồ sơ11 cập nhật