The European Commission will review the recommendation and is expected to issue a final decision in the coming months.
- In February, CHMP issued a negative opinion on Daybue for Rett syndrome, recommending against approval in Europe.
- Acadia Pharmaceuticals responded by requesting a formal re-examination of the opinion.
- Daybue is already approved and being used by patients in the United States, Canada, and Israel.
Shares of Acadia Pharmaceuticals Inc (ACAD) jumped 15% on Friday after a key European medicines committee recommended approval of its drug Daybue for Rett syndrome upon reevaluation.
The stock is now on track to clock its best session since May 2025, if gains hold.
ACAD Buoyed By Positive Recommendation
The Committee for Medicinal Products for Human Use issued a positive opinion for Daybue, the company said on Friday. The medicine is recommended for adults and children aged five and older to help with the main symptoms of Rett syndrome.
The European Commission will review the recommendation and is expected to issue a final decision in the coming months. If approved by the European Commission, Daybue would be available across all 27 EU countries plus Iceland, Liechtenstein, and Norway, and become the first treatment specifically approved in the European Union for this rare condition.
Rett syndrome is a rare genetic disorder that mostly affects girls. Children usually develop normally in their first months or years, then begin to lose skills such as talking, using their hands, and walking. Many need round-the-clock care for life.
Daybue is already approved and being used by patients in the United States, Canada, and Israel.
CHMP’s Pivot
In February, CHMP issued a negative opinion on Daybue for Rett syndrome, recommending against approval in Europe. While the main clinical trial showed some improvement in patients after 12 weeks of treatment, the committee concluded that the benefits were too small to be considered meaningful. They also felt the study did not fully measure all the core symptoms of Rett syndrome and that the longer-term data was difficult to interpret because many patients stopped taking the drug during the trial. Acadia Pharmaceuticals responded by requesting a formal re-examination of the opinion.
How Did ACAD Retail Traders React?
On Stocktwits, retail sentiment around ACAD stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume increased from ‘normal’ to ‘high’ levels. According to the platform’s internal data, retail chatter around ACAD has exploded 400% over the past seven days.
A Stocktwits user said Acadia has “true acquisition value” and added that $50 per share would be a fair price for the company, highlighting optimism in the company’s experimental drug Remlifanserin being developed for Alzheimer’s disease psychosis. Data from a mid-stage trial of the drug is expected between August and October 2026.
ACAD stock has gained 18% over the past 12 months.
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