Here's Why Agios Pharmaceuticals Stock Soared Today (Hint: It's FDA-Related)
The company received some good news on its most important drug today.
Overview
Shares in Agios Pharmaceuticals (NASDAQ: AGIO) were higher by more than 14% as of 11 a.m this morning. The move comes after a very positive development from the Food and Drug Administration (FDA) on its key drug, mitapivat.
The company already has mitapivat approved for adults with pyruvate kinase (PK) deficiency and for adults with alpha- or beta-thalassemia. However, it's also seeking approval for sickle cell disease (SCD) based on a Phase 3 trial completed last year. The good news is the trial met its primary endpoint of "hemoglobin response and key secondary endpoints of change from baseline in hemoglobin concentration and indirect bilirubin."
Details
However, it did not meet the primary endpoint of demonstrating a statistically significant reduction in sickle cell pain crises (SCPCs). Sickle cells can build up in blood vessels, blocking blood flow and depriving organs of oxygen-rich blood, leading to acute pain.
Source
Originally published at www.fool.com.