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Ascelia Pharma sees potential FDA approval path after NDA rejection
Dagens IndustriLO·SE · US·1 day ago
Ascelia Pharma shares fell sharply after the FDA reaffirmed its requirement for a new study of Orviglance, the same candidate that triggered a 75% collapse in July. The decision confirms the regulatory setback and prolongs uncertainty over the drug's approval timeline. This is a company-specific event with no broader market implications.