Acadia’s Plateauing Nuplazid Sales And Patent Cliff Overshadow Positive Trofinetide Development


  • Rett Syndrome is a rare genetic disorder affecting females that results in a slow deterioration in gross motor function, with respiratory illnesses and seizure-related conditions as the most common causes.
  • Trofinetide is a synthetic glycine-proline-glutamate analog increasing brain-derived neurotrophic factor expression, essential for neuronal and synaptic development.
  • A phase 3 study showed significant improvement in primary and secondary endpoints in 187 Rett Syndrome patients, but mild-to-moderate diarrhea and vomiting led to higher treatment discontinuation rates.
  • Trofinetide could generate $500 million annually for Acadia. The drug’s PDUFA date is March 12, 2023. Barring unpredictable surprises, like CMC issues, approval is anticipated.
  • However, Acadia’s leading drug Nuplazid failed to expand its indications and with trofinetide’s launch, Acadia’s valuation may not increase substantially. Acadia may owe Neuren millions of dollars and have to raise additional capital soon. My personal recommendation is to “Sell”.

Diagnosis Rett syndrome and tablets on a wooden table.



Acadia Pharmaceuticals (NASDAQ:ACAD) specializes in developing and commercializing innovative medicines to meet the unmet medical needs of central nervous system disorders. One of its leading products is Nuplazid (pimavanserin), which received FDA approval in April 2016 for treating hallucinations

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