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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- Acadia Pharmaceuticals to Announce First Quarter Financial Results on May 8, 2024 [Yahoo! Finance]Yahoo! Finance
- Acadia Pharmaceuticals to Announce First Quarter Financial Results on May 8, 2024Business Wire
- Acadia Pharmaceuticals Announces Trofinetide New Drug Submission for Treatment of Rett Syndrome Has Been Accepted for Filing and Priority Review by Health Canada [Yahoo! Finance]Yahoo! Finance
- Acadia Pharmaceuticals Announces Trofinetide New Drug Submission for Treatment of Rett Syndrome Has Been Accepted for Filing and Priority Review by Health CanadaBusiness Wire
- Acadia Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
ACAD
Earnings
- 2/27/24 - Miss
ACAD
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEF
- 4/15/24 - Form 3
- ACAD's page on the SEC website