HUTCHMED (China) Ltd
sovleplenib
warm antibody autoimmune hemolytic anemia
Date
TBD
FDA decision · Date TBD estimated
What's at stake
The FDA's approval decision on sovleplenib for warm antibody autoimmune hemolytic anemia is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 6-K
verified 12h ago
“The NMPA granted Breakthrough Therapy Designation to sovleplenib for the treatment of wAIHA in March 2026.”