By Kimberly Chin

Intellia Therapeutics Inc. said the U.S. Food and Drug Administration has granted its acute myeloid leukemia treatment an orphan drug designation.

NTLA-5001 is an autologous T-cell receptor therapy that targets the Wilms' Tumor antigen, which is a common expression in acute myeloid leukemia and other hematologic and solid tumors.

The treatment is currently being reviewed in a Phase 1/2a study in adults who have a detectable sign of the disease and have received standard first-line treatment, the clinical-stage genome editing company said.

The FDA's designation is granted to drugs that are intended for the treatment, diagnosis or prevention of rare diseases that can affect fewer than 200,000 people in the U.S. Drugs that receive the designation can qualify companies for certain tax credits, prescription drug user-fee exemptions and a seven-year marketing exclusivity once the drug is approved by the FDA.

Write to Kimberly Chin at kimberly.chin@wsj.com

(END) Dow Jones Newswires

March 09, 2022 16:38 ET (21:38 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
Intellia Therapeutics (NASDAQ:NTLA)
Historical Stock Chart
From Jun 2024 to Jul 2024 Click Here for more Intellia Therapeutics Charts.
Intellia Therapeutics (NASDAQ:NTLA)
Historical Stock Chart
From Jul 2023 to Jul 2024 Click Here for more Intellia Therapeutics Charts.