FDA Accepts Agios' sNDA for Pyrukynd in Thalassemia
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The FDA has accepted Agios Pharmaceuticals' supplemental New Drug Application (sNDA) for Pyrukynd, which could become the first oral therapy for all thalassemia subtypes. A decision is expected by September 7.

January 09, 2025 | 2:30 pm
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Agios Pharmaceuticals' sNDA for Pyrukynd has been accepted by the FDA, potentially making it the first oral therapy for all thalassemia subtypes. A decision is expected by September 7.
The acceptance of the sNDA by the FDA is a significant step for Agios Pharmaceuticals, as it could lead to Pyrukynd becoming the first oral therapy for thalassemia. This development is likely to positively impact AGIO's stock price in the short term, especially if the FDA decision is favorable.
CONFIDENCE 90
IMPORTANCE 80
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