Intellia : la FDA lève la suspension clinique de l'essai de phase 3 MAGNITUDE ATTR-CM

La FDA a levé la suspension clinique de l'IND de phase 3 MAGNITUDE pour nex-z dans l'ATTR-CM. Une surveillance hépatique renforcée, des recommandations de corticothérapie à court terme et des critères d'exclusion supplémentaires pour l'instabilité cardiovasculaire et une fraction d'éjection basse ont été convenus afin de reprendre les inclusions.

Faits clés

Déposé: 2 mars 2026, 13:16
Événement: Inspection de fabrication
Direction: Positif
Société: NTLAIntellia
Actif: nexiguran ziclumeran
Source: SEC 8-K
Fiabilité: Sourcé

Extrait de la source

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