Intellia Therapeutics stock surged Tuesday after the FDA aid it would allow the company to restart a gene-editing study.
Intellia is instituting new safeguards following the death of a study participant that led regulators to pause two trials in ...
After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs for hereditary transthyretin amyloidosis.
Gene editing company Intellia Therapeutics has announced that the US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the ...
The FDA had placed a clinical hold on Phase III trials of nex-z in ATTR-PN and ATTR-CM after a patient experienced a serious adverse event and died.
The FDA has lifted a clinical hold on Intellia Therapeutics’ Magnitude-2 phase 3 trial of nexiguran ziclumeran, or nex-z: a CRISPR-based gene therapy for patients with hereditary transthyretin ...
The hold followed Intellia’s voluntary pause in response to a grade 4 liver event—a case of Hy’s Law—in the ATTR-CM trial. Shortly after the regulatory hold was implemented, Intellia disclosed that ...
Good morning. A new startup focused on GLP-1 drugs launched today, but unlike the dozens of other GLP-1 companies, this one isn’t studying weight loss. Roche plans to launch Phase 3 studies of its ...
The company said Tuesday that the FDA lifted the hold on an Investigational New Drug Application for a phase 3 clinical trial of nexiguran ziclumeran, or nex-z, for patients with a genetic disease ...
U.S. stocks were mixed, with the Dow Jones falling over 400 points on Tuesday. Shares of HCA Healthcare Inc (NYSE: HCA) rose sharply during Tuesday's session after the company reported ...
Investing.com -- Intellia Therapeutics (NASDAQ:NTLA) stock soared 20% Tuesday after the U.S. Food and Drug Administration (FDA) lifted a clinical hold on the company’s MAGNITUDE-2 Phase 3 trial for ...
Plan to resume MAGNITUDE-2 patient enrollment and dosing FDA engagement ongoing regarding clinical hold on MAGNITUDE Phase 3 ...