Aeglea BioTherapeutics Inc

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Aeglea Biotherapeutics Receives Refusal To File Letter From FDA For Pegzilarginase For The Treatment Of Arginase 1 Deficiency

Published: 06/02/2022 13:11 GMT
Aeglea BioTherapeutics Inc (AGLE) - Aeglea Biotherapeutics Receives Refusal to File Letter From FDA for Pegzilarginase for the Treatment of Arginase 1 Deficiency.
Aeglea Bio Therapeutics Inc - in Rtf Letter FDA Requested Additional Data to Support Effectiveness.
Aeglea Bio Therapeutics Inc- There Were No Issues Related to Safety Raised in Letter.
Aeglea Bio Therapeutics Inc - Intends to Request a Type a Meeting With FDA to Clarify and Respond to Items Identified in Rtf Letter.
Aeglea Bio Therapeutics - in Letter, FDA Also Requested Additional Information Relating to Chemistry Manufacturing and Controls.
Aeglea Bio Therapeutics Inc - There Were No Issues Related to Safety Raised in Rtf Letter by FDA.