Intellia: FDA retira a suspensão clínica do ensaio MAGNITUDE Fase 3 em ATTR-CM

A FDA removeu a suspensão clínica do IND MAGNITUDE Fase 3 para nex-z em ATTR-CM. Monitoramento hepático aprimorado, orientação para uso de esteroides de curto prazo e critérios adicionais de exclusão para instabilidade cardiovascular e baixa fração de ejeção foram acordados para retomar o recrutamento.

Fatos principais

Arquivado: 2 de mar. de 2026, 13:16
Evento: Inspeção de fabricação
Direção: Positivo
Empresa: NTLAIntellia
Ativo: nexiguran ziclumeran
Fonte: SEC 8-K
Confiança: Com fonte

Trecho da fonte

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