H.C. Wainwright sees FDA Priority Review as positive signal for Agios' mitapivat
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.
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.