FDA AdComm Rejects Nuplazid This Time But Acadia’s Race Isn’t Run Yet


  • Acadia won approval for its only commercialized drug Nuplazid in 2017 and has tried and failed to expand its label since.
  • This month an FDA AdComm voted against an approval in Alzheimer’s disease psychosis, despite the FDA issuing positive briefing notes.
  • Acadia is heavily loss making to the tune of ~$200m per annum even while guiding for >$500m in sales of Nuplazid this year.
  • There’s an opportunity to gain approval for the drug in Negative Symptoms of Schizophrenia and a further opportunity in RETT syndrome for another drug, Trofinetide.
  • Shares are down >50% in response to the AdComm verdict but I expect them to climb again with three major opportunities in play. This represents a high risk investment however given finances.

Sisyphus pushing a rock up a hill. Working hard. Ambition.

Daniel Balakov/iStock via Getty Images

Investment Opportunity Overview

San Diego based Acadia Pharmaceuticals (NASDAQ:ACAD) – a specialist developer of drugs to treat Central Nervous System (“CNS”) disorders – has been listed on the Nasdaq since 2004, and for those who invested back then and

Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in ACAD over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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