AGIO News & Events

Agios Pharmaceuticals is up 13.5%, or $5.04 to $42.43.

Leerink notes that Agios Pharmaceuticals announced the FDA granted Priority Review for the sNDA for mitapivat in sickle cell disease with a PDUFA date of 11/1/26 suggesting imminent approval. The Phase 3 REIGNITE trial is the confirmatory study required under the accelerated approval pathway and the agency requires that the trial be "underway" at the time of accelerated approval, with the definition of "underway" agreed upon by the agency and Agios. The firm sees the Priority Review designation as a positive sign given that Priority Review is granted to applications which, if approved, would demonstrate significant improvements of serious conditions. Leerink models peak U.S. sales of $554M for mitapivat in SCD with a 60% probability of success. The firm has an Outperform rating on the shares.

H.C. Wainwright analyst Emily Bodnar notes that Agios Pharmaceuticals announced that the FDA accepted its sNDA for mitapivat, in sickle cell disease under the accelerated approval pathway with a Priority Review and a PDUFA goal date of November 1, 2026. The firm views the Priority Review as a positive regulatory signal, implying that the FDA sees mitapivat as a potential meaningful advance for an underserved, serious condition, warranting a compressed review period of six months vs the standard 10 months. This pulls a potential approval forward by about four months, accelerating the path to launch. Wainwright continues to expect a broad SCD label and a steadfast launch leveraging mitapivat's established hematologist prescriber base. The firm has a Buy rating on Agios with a price target of $54 on the shares.

Agios Pharmaceuticals is up 12.9%, or $4.81 to $42.20.