Intellia: Inalis ng FDA ang clinical hold sa MAGNITUDE Phase 3 ATTR-CM trial

Inalis ng FDA ang clinical hold sa MAGNITUDE Phase 3 IND para sa nex-z sa ATTR-CM. Napagkasunduan ang pinahusay na liver monitoring, short-term steroid guidance, at karagdagang exclusion criteria para sa cardiovascular instability at low ejection fraction upang ipagpatuloy ang enrollment.

Mahahalagang fact

Na-file: Mar 2, 2026, 01:16 PM
Kaganapan: Inspeksyon sa manufacturing
Direksyon: Positibo
Kumpanya: NTLAIntellia
Asset: nexiguran ziclumeran
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa 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