Intellia: FDA angkat penahanan klinis pada uji coba MAGNITUDE Phase 3 ATTR-CM

FDA telah mencabut penahanan klinis pada IND MAGNITUDE Phase 3 untuk nex-z pada ATTR-CM. Pemantauan hati yang ditingkatkan, panduan steroid jangka pendek, dan kriteria eksklusi tambahan untuk ketidakstabilan kardiovaskular dan fraksi ejeksi rendah telah disepakati untuk melanjutkan pendaftaran.

Fakta utama

Diajukan: 2 Mar 2026, 13.16
Peristiwa: Inspeksi manufaktur
Arah: Positif
Perusahaan: NTLAIntellia
Aset: nexiguran ziclumeran
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 3 d101756dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 AMENDMENT NO. 2 TO THE OPEN MARKET SALE AGREEMENT SM March 2, 2026 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: This Amendment No. 2 to the Open Market Sale Agreement SM , dated as of March 2, 2026, is entered into by and between Intellia Therapeutics, Inc. (the “ Company ”) and Jefferies LLC (the “ Agent ”). Capitalized terms used but not otherwise defined herein shall have the respective meanings ascribed to them in the Sales Agreement (as defined below). WHEREAS, the Company and the Agent have entered into that certain Open Market Sale Agreement SM , dated March 4, 2022, as amended by that certain Amendment to the Open Market Sale Agreement SM , dated as of February 23, 2024 (the “ Sales A

SEC 8-K