ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Rare Pediatric Disease Designation for Trofinetide for the Treatment of Rett Syndrome
ACADIA Pharmaceuticals Inc. (ACAD)
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Source: Business Wire
With No Approved Treatments in Rett Syndrome, FDA Decision Highlights Significant Unmet Need SAN DIEGO & MELBOURNE, Australia--(BUSINESS WIRE)--ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) and Neuren Pharmaceuticals Limited (ASX: NEU) announced today that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder. Upon FDA approval of a product with RPD designation, the sponsor may be eligible to receive a Priority Review Voucher, which can be used to obtain FDA review of a New Drug Application for another product in an expedited period of six months.This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200303006075/en/"We are pleased that the FDA has recognized the unmet need currently experienced by Rett patients and their families and our goal is to bring a treatment option forward as soon as possible,”
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ACAD
Earnings
- 11/6/24 - Beat
ACAD
Sec Filings
- 11/14/24 - Form SC
- 11/7/24 - Form 10-Q
- 11/6/24 - Form 8-K
- ACAD's page on the SEC website