Firstly, Acadia has stated that it expects to file the NDA for trofinetide “around mid-year”. That doesn’t necessarily mean it will be filed by 30 June.
Re the PRV, this post from February 2020 explains how it works. Since then, Acadia has applied for and received the necessary rare paediatric disease designation and the 30 September 2022 deadline for marketing approval no longer applies as US legislators voted in September 2020 to extend the RPD PRV scheme by four years.
Finally, re the ACAD rise last night, I suspect it’s most likely related to the fact that the FDA Advisory Committee meeting to review Acadia’s sNDA for pimavanserin in Alzheimer’s Disease Psychosis is now just 2 weeks away (17 June). This is big for Acadia and its investors.
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