Acadia Pharmaceuticals ACAD announced that the European Commission (EC) has granted marketing authorization for Daybu (trofinetide) to treat neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. The nod marks a major regulatory milestone for the therapy as it is now the first and only treatment approved for this indication in the EU.
The EU approval enables Acadia to expand Daybu’s commercial footprint across all 27 EU member states, as well as Iceland, Liechtenstein and Norway, strengthening the long-term growth potential of its rare disease franchise. As a next step, Acadia will now begin pricing and reimbursement negotiations with relevant national authorities to potentially bring Daybu to patients across the EU.
The EC approval was expected as the advisory committee to the European Medicines Agency adopted a positive opinion in June 2026 recommending the approval of Daybu for Rett Syndrome. It is a rare, neurodevelopmental disorder marked by developmental regression, severe motor impairment and lifelong care needs. The FDA approved trofinetide as the first and only treatment for Rett syndrome in adults and pediatric patients aged two years and older in 2023. The drug is marketed under the brand name Daybue in the United States. Daybue is also marketed (and available) in Canada and Israel for the same indication.
The EC approval is primarily supported by data from the pivotal phase III LAVENDER study, which demonstrated statistically significant and clinically meaningful improvements in key measures of Rett syndrome. The study met its co-primary endpoints, showing benefits on the Rett Syndrome Behavior Questionnaire and the Clinical Global Impression-Improvement scale, indicating that Daybu can improve some of the core neurobehavioral manifestations of the disease that substantially affect patients' daily functioning and caregiver burden.
Year to date, Acadia shares have gained 10.5% compared with the industry’s 11.1% growth.
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ACAD's Marketed Drugs Expected to Aid Growth
Acadia’s long-term growth is anchored by its two marketed products, Nuplazid and Daybue. The company continues to target approximately $1.7 billion in combined annual net sales by 2028, including roughly $1 billion for Nuplazid and $700 million for Daybue.
Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. The drug enjoys patent protection in the United States until 2038, giving it a long runway for revenue generation by protecting against generic erosion. In the first half of 2026, Nuplazid generated $350.1 million in net product sales, up 7% from the year-ago period. The increase was primarily driven by higher unit sales, highlighting continued underlying demand for the drug.
Since its launch in 2023, Daybue has witnessed encouraging sales uptake. The therapy generated $226 million in net product sales in the first half of 2026, up 25% year over year, with the increase primarily reflecting higher unit sales. The EU approval of the drug is expected to further boost sales in the upcoming quarters.
Meanwhile, Daybue STIX, a dye- and preservative-free powder formulation of trofinetide, was broadly launched in the United States in the second quarter of 2026. The formulation provides patients and caregivers greater flexibility while maintaining the same efficacy and safety profile as the original oral solution. Its strong uptake contributed to Daybue’s 30% year-over-year sales growth in the second quarter.
Overall, Acadia’s commercial portfolio remains on a solid growth trajectory. Following second-quarter results, the company raised its 2026 Daybue sales projection to $480-$510 million from the previous guided range of $460-$490 million while maintaining Nuplazid sales guidance of $760-$790 million.
ACADIA Pharmaceuticals Inc. Price and Consensus
ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote
ACAD's Zacks Rank & Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals AMRX, Repligen RGEN and AC Immune ACIU. AMRX and RGEN currently sport a Zacks Rank #1 (Strong Buy) each, while ACIU carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, earnings estimates increased from $1.12 to $1.21 for 2027. AMRX shares have risen 42.1% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61. RGEN shares have gained 10.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 7.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
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