Agios Pharmaceuticals, Inc.
mitapivat
sickle cell disease
Resolved
98days ago
Advisory committee · ~ Mar 31, 2026 estimated
What's at stake
An FDA advisory committee reviews mitapivat for sickle cell disease around ~ Mar 31, 2026. The panel's public vote often front-runs the agency's final verdict — and the share price.
Primary source
· SEC 8-K
verified 16h ago
“Agios will have a pre-supplemental New Drug Application (sNDA) meeting with the FDA in the first quarter of 2026 and intends to submit a U.S. marketing application for mitapivat in sickle cell disease following that engagement.”