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Acadia Gets FDA's Fast Track Tag for Alzheimer's Disease Candidate
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Key Takeaways
Acadia received FDA Fast Track designation for remlifanserin in Alzheimer's disease psychosis.
ACAD expects phase II top-line data between September and October 2026 as phase III enrollment continues.
Acadia expects Nuplazid and Daybue combined net sales of about $1.7 billion by 2028.
Acadia Pharmaceuticals (ACAD - Free Report) announced that the FDA has granted Fast Track designation to its investigational, highly selective, 5-HT2A receptor inverse agonist, remlifanserin, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The FDA’s Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fulfill unmet medical needs to get important new drugs to patients earlier. It offers benefits, such as more frequent FDA interactions, rolling submission of marketing applications and potential eligibility for Priority Review if certain conditions are met.
According to Acadia, there are currently no FDA-approved therapies for treating ADP.
More on ACAD’s RemlifanserinClinical Development Program
Acadia is currently evaluating the safety and efficacy of remlifanserin in the RADIANT development program for the treatment of hallucinations and delusions associated with ADP. The company has completed enrollment in the phase II portion of the program and now expects to report top-line results between September and October 2026. Meanwhile, in line with the RADIANT program's seamless operational design, screening and patient enrollment are already underway for the phase III studies. In 2025, ACAD initiated another phase II study of remlifanserin for a second indication – Lewy Body Dementia with Psychosis.
Year to date, ACAD shares have lost 6% against the industry’s 2.4% growth.
Image Source: Zacks Investment Research
Apart from remlifanserin, Acadia’s clinical pipeline comprises several other candidates. The company, in partnership with Saniona, is gearing up to initiate a mid-stage study of ACP-711 for essential tremor in late 2026. In late 2025, ACAD initiated a mid-stage study of ACP-211 for the treatment of major depressive disorder. A first-in-human study of ACP-271 in healthy volunteers was also initiated in the first quarter of 2026.
ACAD's Marketed Drugs Expected to Aid Growth
Acadia’s long-term growth is supported by its lead product, Nuplazid and Daybue, in the United States. The company expects to generate around $1.7 billion in combined net sales by 2028, including $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 quarter of 2026, Nuplazid recorded $167 million in sales, up 5% year over year, driven primarily by volume growth.
Since its U.S. launch in 2023 as the first and only treatment for Rett syndrome in adults and pediatric patients aged two years and older, Daybue has witnessed encouraging sales uptake. In the first quarter of 2026, Daybue recorded $101 million in sales, up 20% year over year, driven by growth in the drug’s unit sales as Acadia shipped it to more unique patients. A similar filing is also currently under regulatory review in the EU. A potential nod could further boost sales. Daybue is also marketed (and available) in Canada and Israel for the same indication.
In late 2025, the FDA approved Daybue Stix (trofinetide), a dye- and preservative-free powder formulation for the treatment of Rett syndrome in adults and pediatric patients aged two years and older. The new product expands the Daybue franchise, which remains the only FDA-approved treatment option for this indication.
Daybue Stix is now broadly available in the United States. The company will continue to offer the current oral solution alongside the new formulation, strengthening its positioning in the Rett syndrome treatment market.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.44. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 22% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, loss per share estimates for Amarin have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have lost 2.5% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have soared 123.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%.
View the Zacks #1 Rank List
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Acadia Gets FDA's Fast Track Tag for Alzheimer's Disease Candidate
Key Takeaways
Acadia Pharmaceuticals (ACAD - Free Report) announced that the FDA has granted Fast Track designation to its investigational, highly selective, 5-HT2A receptor inverse agonist, remlifanserin, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The FDA’s Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fulfill unmet medical needs to get important new drugs to patients earlier. It offers benefits, such as more frequent FDA interactions, rolling submission of marketing applications and potential eligibility for Priority Review if certain conditions are met.
According to Acadia, there are currently no FDA-approved therapies for treating ADP.
More on ACAD’s RemlifanserinClinical Development Program
Acadia is currently evaluating the safety and efficacy of remlifanserin in the RADIANT development program for the treatment of hallucinations and delusions associated with ADP. The company has completed enrollment in the phase II portion of the program and now expects to report top-line results between September and October 2026. Meanwhile, in line with the RADIANT program's seamless operational design, screening and patient enrollment are already underway for the phase III studies. In 2025, ACAD initiated another phase II study of remlifanserin for a second indication – Lewy Body Dementia with Psychosis.
Year to date, ACAD shares have lost 6% against the industry’s 2.4% growth.
Image Source: Zacks Investment Research
Apart from remlifanserin, Acadia’s clinical pipeline comprises several other candidates. The company, in partnership with Saniona, is gearing up to initiate a mid-stage study of ACP-711 for essential tremor in late 2026. In late 2025, ACAD initiated a mid-stage study of ACP-211 for the treatment of major depressive disorder. A first-in-human study of ACP-271 in healthy volunteers was also initiated in the first quarter of 2026.
ACAD's Marketed Drugs Expected to Aid Growth
Acadia’s long-term growth is supported by its lead product, Nuplazid and Daybue, in the United States. The company expects to generate around $1.7 billion in combined net sales by 2028, including $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 quarter of 2026, Nuplazid recorded $167 million in sales, up 5% year over year, driven primarily by volume growth.
Since its U.S. launch in 2023 as the first and only treatment for Rett syndrome in adults and pediatric patients aged two years and older, Daybue has witnessed encouraging sales uptake. In the first quarter of 2026, Daybue recorded $101 million in sales, up 20% year over year, driven by growth in the drug’s unit sales as Acadia shipped it to more unique patients. A similar filing is also currently under regulatory review in the EU. A potential nod could further boost sales. Daybue is also marketed (and available) in Canada and Israel for the same indication.
In late 2025, the FDA approved Daybue Stix (trofinetide), a dye- and preservative-free powder formulation for the treatment of Rett syndrome in adults and pediatric patients aged two years and older. The new product expands the Daybue franchise, which remains the only FDA-approved treatment option for this indication.
Daybue Stix is now broadly available in the United States. The company will continue to offer the current oral solution alongside the new formulation, strengthening its positioning in the Rett syndrome treatment market.
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 Neurocrine Biosciences (NBIX - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.44. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 22% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, loss per share estimates for Amarin have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have lost 2.5% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have soared 123.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%.