Intellia Therapeutics Inc's (NASDAQ:NTLA) CRISPR-powered T cell therapy has received an FDA orphan drug designation.
- The autologous T cell receptor therapy, dubbed NTLA-5001, is being evaluated in a Phase 1/2a trial in acute myeloid leukemia, the white blood cell cancer that affects blood and bone marrow.
- A week ago, the company dosed the first patient in the NTLA-5001 Phase 1/2a trial in AML after receiving standard first-line therapy. The trial will enroll 54 patients.
- Read Next: Intellia Shares Updated Data On Gene Editing Durability In Rare Disease.
- With the orphan drug status, Intellia snags the potential for tax credits on clinical testing, plus fee exemptions and a seven-year marketing exclusivity should NTLA-5001 secure an FDA green light.
- Related content: Benzinga's Full FDA Calendar.
- The designation is granted to therapeutics that aim to treat diseases impacting 200,000 or fewer people in the U.S.
- Price Action: NTLA shares closed 1.64% higher at $67.07 during after-hours trading on Wednesday.
