- The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ALX Oncology's ( NASDAQ: ALXO ) evorpacept to treat patients with acute myeloid leukemia (AML).
- "Receiving orphan drug designation in AML, and previously in gastric cancer, from the FDA is an important regulatory milestone and reflects the FDA’s recognition of evorpacept’s potential to improve clinical outcomes in patients with these advanced cancers," said ALX's Chief Medical Officer Sophia Randolph.
- The FDA grants orphan drug status to therapies that treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.
- ALXO +14.39% to $9.22 premarket June 29
For further details see:
ALX Oncology stock rises 14% on evorpacept's FDA orphan drug status for blood cancer