We were advised in NEU’s Q2 2024 update last week that Acadia’s Paediatric Investigation Plan for trofinetide in Rett syndrome had been agreed to by the EMA. For a new paediatric drug, a PIP has to be submitted to and agreed to by the EMA before you can submit an MMA for marketing approval can be submitted. The PIP procedure is said to typically take 9-12 months. That bit is now done.
It was also advised that Acadia intends to submit the MMA for European marketing approval for DayBue in Q 1 next year. Assuming the Accelerated Assessment pathway is taken, it might take ~12 months for approval. If things run smoothly,DayBue might on the market in Europe by Q2 2026.
Reata submitted its MMA for SkyClarys in November or December 2022, received recommendation for approval in December 2023 and formal marketing approval in February 2024.
NEU Price at posting:
$16.23 Sentiment: Hold Disclosure: Held
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