Agios Pharmaceuticals, Inc. - Common Stock (AGIO)

While the FDA was originally expected to decide on the company’s application for Pyrukynd in treating thalassemia by September 7, its decision is now expected by December 7.

Agios' Pyrukynd FDA review for thalassemia delayed to Dec. 7, 2025, after REMS submission addressing potential liver injury risk.

As we await the opening of the US market on Thursday, let's delve into the pre-market session and discover the top gainers and losers shaping the early market sentiment.

Let's delve into the US markets on Monday and uncover the stocks that are experiencing notable gaps in today's session. Below, you'll find the gap up and gap down stocks.

As the US market prepares to open on Monday, let's get an early glimpse into the pre-market session and identify the stocks leading the pack in terms of gains and losses.

Agios Pharmaceuticals (AGIO) reported Q2 2025 revenue of $12.46M, beating estimates, but EPS of -$1.93 missed forecasts. Shares fell 10.66% pre-market amid mixed financials and ongoing rare disease pipeline progress.

Agios' mitapivat met its primary endpoint in a Phase 3 trial for PK deficiency in children. The company plans a marketing application based on the results.

The company is currently seeking approval for its thalassemia treatment in four regions.