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ACAD Stock Down 13% as Phase II Alzheimer's Study Misses Primary Goal
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Key Takeaways
ACAD's 60 mg remlifanserin dose narrowly missed the main goal of change from baseline in SAPS-H D at week 6.
The 60 mg dose improved CGI-S-ADP by 1.3 points versus 0.9 for placebo, with nominal significance.
Acadia will remove the 30 mg arm and focus ongoing phase III studies on the 60 mg dose.
Acadia Pharmaceuticals (ACAD - Free Report) announced phase III-enabling top-line results from the phase II portion of the RADIANT study evaluating remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Per ACAD, the findings support continued phase III development of the 60 mg once-daily dose, despite the study narrowly missing the primary efficacy endpoint. The stock was down 12.8% on Thursday, likely reflecting investor disappointment over the efficacy outcome.
Remlifanserin, a novel, highly selective 5HT2A receptor inverse agonist, is being developed as an oral, once-daily treatment for the ADP indication. Acadia’s RADIANT clinical program seamlessly combines phase II and phase III development. In the phase II portion, patients were randomized to receive once-daily remlifanserin at 60 mg or 30 mg, or placebo, and were monitored for six weeks. The study evaluated the efficacy, safety, and tolerability of the remlifanserin doses compared with placebo in ADP patients.
Detailed Results From Phase II Portion of ACAD's ADP Program
Per Acadia’s phase II ADP data readout, patients receiving 60 mg remlifanserin posted a 12.6-point improvement from baseline in the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D), compared with a 10.4-point improvement for placebo, at week 6. SAPS-H+D is a clinical measure used to assess the severity of hallucinations and delusions, with greater reductions indicating an improvement in symptoms. The study narrowly missed the primary endpoint of change from baseline in SAPS-H+D.
However, the treatment difference translated into a standardized effect size of 0.26. Acadia noted that the separation between the 60 mg dose and placebo increased through the six-week treatment period, supporting evidence of a dose effect.
Year to date, ACAD shares have lost 16.9% against the industry’s 6.3% growth.
Image Source: Zacks Investment Research
The 60 mg dose also produced a stronger result on the key secondary endpoint, Clinical Global Impression-Severity for ADP (CGI-S-ADP). It is a clinician-rated measure of overall ADP severity, with lower scores indicating less severe symptoms. At week 6, CGI-S-ADP improved by 1.3 points from baseline with 60 mg remlifanserin versus 0.9 points for placebo, demonstrating nominal statistical significance. The treatment difference translated into a standardized effect size of 0.37.
By contrast, the 30 mg dose showed minimal improvement compared with placebo across the efficacy measures. All analyses were conducted in the pre-specified modified full analysis set population.
Safety findings were favorable across both remlifanserin doses. Rates of adverse events, serious adverse events and treatment discontinuations due to adverse events were similar to placebo. The study found no signal of QT prolongation versus placebo, while the dataset did not suggest negative effects on motor symptoms or cognition. No deaths occurred in the remlifanserin treatment groups, adding to the favorable tolerability profile reported in the study.
ACAD's Next Steps
Acadia plans to continue enrollment in the two ongoing phase III studies under the RADIANT program evaluating remlifanserin for ADP while amending the program to remove the 30 mg arm and focus development on the 60 mg once-daily dose. The company plans to present detailed phase II safety and efficacy findings at an upcoming medical conference. The additional data could provide greater visibility into the candidate’s efficacy and tolerability profile.
ADP is a serious complication of Alzheimer’s disease involving hallucinations and delusions. Per the Alzheimer’s Association, more than seven million people in the United States are living with Alzheimer’s disease and approximately 30% of patients are estimated to experience psychosis. These symptoms can be frequent, severe and recurrent and are associated with adverse outcomes, including a higher likelihood of nursing home placement and increased morbidity and mortality. Per Acadia, there is currently no FDA-approved drug specifically indicated for ADP, underscoring the unmet medical need.
Acadia is also evaluating remlifanserin in a separate phase II study for the treatment of psychosis associated with Lewy body dementia. The study represents an additional clinical development opportunity for remlifanserin.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
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 15.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 76.4% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
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ACAD Stock Down 13% as Phase II Alzheimer's Study Misses Primary Goal
Key Takeaways
Acadia Pharmaceuticals (ACAD - Free Report) announced phase III-enabling top-line results from the phase II portion of the RADIANT study evaluating remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Per ACAD, the findings support continued phase III development of the 60 mg once-daily dose, despite the study narrowly missing the primary efficacy endpoint. The stock was down 12.8% on Thursday, likely reflecting investor disappointment over the efficacy outcome.
Remlifanserin, a novel, highly selective 5HT2A receptor inverse agonist, is being developed as an oral, once-daily treatment for the ADP indication. Acadia’s RADIANT clinical program seamlessly combines phase II and phase III development. In the phase II portion, patients were randomized to receive once-daily remlifanserin at 60 mg or 30 mg, or placebo, and were monitored for six weeks. The study evaluated the efficacy, safety, and tolerability of the remlifanserin doses compared with placebo in ADP patients.
Detailed Results From Phase II Portion of ACAD's ADP Program
Per Acadia’s phase II ADP data readout, patients receiving 60 mg remlifanserin posted a 12.6-point improvement from baseline in the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D), compared with a 10.4-point improvement for placebo, at week 6. SAPS-H+D is a clinical measure used to assess the severity of hallucinations and delusions, with greater reductions indicating an improvement in symptoms. The study narrowly missed the primary endpoint of change from baseline in SAPS-H+D.
However, the treatment difference translated into a standardized effect size of 0.26. Acadia noted that the separation between the 60 mg dose and placebo increased through the six-week treatment period, supporting evidence of a dose effect.
Year to date, ACAD shares have lost 16.9% against the industry’s 6.3% growth.
Image Source: Zacks Investment Research
The 60 mg dose also produced a stronger result on the key secondary endpoint, Clinical Global Impression-Severity for ADP (CGI-S-ADP). It is a clinician-rated measure of overall ADP severity, with lower scores indicating less severe symptoms. At week 6, CGI-S-ADP improved by 1.3 points from baseline with 60 mg remlifanserin versus 0.9 points for placebo, demonstrating nominal statistical significance. The treatment difference translated into a standardized effect size of 0.37.
By contrast, the 30 mg dose showed minimal improvement compared with placebo across the efficacy measures. All analyses were conducted in the pre-specified modified full analysis set population.
Safety findings were favorable across both remlifanserin doses. Rates of adverse events, serious adverse events and treatment discontinuations due to adverse events were similar to placebo. The study found no signal of QT prolongation versus placebo, while the dataset did not suggest negative effects on motor symptoms or cognition. No deaths occurred in the remlifanserin treatment groups, adding to the favorable tolerability profile reported in the study.
ACAD's Next Steps
Acadia plans to continue enrollment in the two ongoing phase III studies under the RADIANT program evaluating remlifanserin for ADP while amending the program to remove the 30 mg arm and focus development on the 60 mg once-daily dose. The company plans to present detailed phase II safety and efficacy findings at an upcoming medical conference. The additional data could provide greater visibility into the candidate’s efficacy and tolerability profile.
ADP is a serious complication of Alzheimer’s disease involving hallucinations and delusions. Per the Alzheimer’s Association, more than seven million people in the United States are living with Alzheimer’s disease and approximately 30% of patients are estimated to experience psychosis. These symptoms can be frequent, severe and recurrent and are associated with adverse outcomes, including a higher likelihood of nursing home placement and increased morbidity and mortality. Per Acadia, there is currently no FDA-approved drug specifically indicated for ADP, underscoring the unmet medical need.
Acadia is also evaluating remlifanserin in a separate phase II study for the treatment of psychosis associated with Lewy body dementia. The study represents an additional clinical development opportunity for remlifanserin.
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 Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
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 15.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 76.4% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.