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Agios submits FDA sNDA for accelerated approval of mitapivat in sickle cell disease

PUBT·05/12/2026 13:33:06
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Agios submits FDA sNDA for accelerated approval of mitapivat in sickle cell disease
  • Agios filed supplemental NDA with FDA seeking accelerated approval of mitapivat for sickle cell disease.
  • Submission followed agreement with FDA on required confirmatory trial; 52-week, placebo-controlled study plans to enroll about 159 patients age 12 or older.
  • Agios expects FDA filing acceptance notice and review timeline in Q3 2026.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Agios Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605120931PRIMZONEFULLFEED9718028) on May 12, 2026, and is solely responsible for the information contained therein.