Agios Pharmaceuticals (AGIO) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Agios Pharmaceuticals, Inc. (AGIO) Discusses FDA Approval of AQVESME for Anemia in Alpha and Beta Thalassemia Transcript

Agios Pharmaceuticals upgraded to buy (market perform) after FDA approval of Aqvesme for Alpha- or Beta-Thalassemia, despite boxed warning for liver injury. AGIO's commercial upside from thalassemia is capped, with peak sales estimates around $500M, insufficient alone for profitability; SCD approval remains a major potential catalyst. AGIO maintains a strong cash position of $1.3B versus $101M in liabilities, providing ample runway for commercialization and further development.

Agios Pharmaceuticals wins FDA approval for Aqvesme in alpha- and beta-thalassemia, making mitapivat the only approved option, despite a new REMS.

The new indication is relatively rare in the U.S., but pricing is substantial, and the need for the treatment is significant. The positive update turns the company's fortunes around after a disappointing update earlier in the year.

Shares of Agios Pharmaceuticals jumped nearly 12% premarket on Wednesday after the U.S. Food and Drug Administration approved the expanded use of its drug for the treatment of a type of blood disorder.

AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Marketed under AQVESME brand name in the U.S. for thalassemia indication; PYRUKYND® (mitapivat) remains the U.S. brand name for PK deficiency indication  AQVESME expected to be available in late January 2026, following AQVESME REMS program implementation Company will host investor conference call and webcast tomorrow, December 24 at 8:00 a.m. ET CAMBRIDGE, Mass.

AGIO faces uncertainty as the FDA misses its Dec. 7 deadline related to the sNDA for Pyrukynd in thalassemia and offers no new timeline.

Agios today announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the sNDA for mitapivat in thalassemia

Fisher Asset Management LLC decreased its holdings in Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) by 8.5% during the undefined quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The fund owned 877,540 shares of the biopharmaceutical company's stock after selling 81,799 shares during the quarter. Fisher Asset