European Commission Adopts Positive Decision for Orphan Medicinal Product Designation of Agios' Mitapivat in Sickle Cell Disease
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Agios Pharmaceuticals' mitapivat receives orphan medicinal product designation from the European Commission for sickle cell disease, following a similar designation by the FDA in 2020.
December 18, 2024 | 12:15 pm
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Agios Pharmaceuticals' mitapivat has been designated as an orphan medicinal product by the European Commission for sickle cell disease, enhancing its market potential in Europe.
The European Commission's designation of mitapivat as an orphan medicinal product for sickle cell disease is a significant regulatory milestone. This status can provide market exclusivity, financial incentives, and reduced regulatory fees, which are likely to positively impact Agios' market position and stock price in the short term.
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