Leerink sees Priority Review designation as positive sign for Agios' mitapivat
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.
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.