The U.S. Food and Drug Administration approved Acadia Pharmaceuticals Inc's drug for the treatment of Rett syndrome, a genetic brain disorder, the company said on Friday, making it the first approved drug for the condition.
Acadia said it plans to make the drug available to patients by the end of April. It did not disclose details of the price.
Acadia forecasts sales of Nuplazid - its only drug on the market - of between $520 and $550 million this year, above analysts' median expectations of $532.8 million, according to Refinitiv data. With the drugmaker facing a loss of exclusivity for Nuplazid in 2028, investors have pinned their hopes on a successful trofinetide launch.
Rett's syndrome is a rare neurodevelopmental condition that occurs primarily in girls. According to government estimates, it affects fewer than 50,000 people in the U.S.Acadia's drug acts as an artificial form of the insulin-like growth factor IGF-1 and helps reduces inflammation in the nervous tissue as well as aid in the transmission of nerve impulses.
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