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FDA Calendar

Company Name ACADIA Pharmaceuticals Inc
ACAD
Drug Name Trofinetide (NDA)
Event Name FDA decision on Trofinetide for the treatment of Rett syndrome
Event Date 03/12/2023
Outcome Date 03/11/2023
Outcome FDA approved Trofinetide, under brand name DAYBUE, for the treatment of Rett syndrome on Mar.11, 2023
Drug Status Priority review
Rival Drugs
Market Potential Trofinetide has the potential to achieve peak U.S. sales of over $400 million to $500 million, according to analysts
Other Approvals
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