ACADIA Pharmaceuticals (NASDAQ:ACAD) executives outlined the company’s revenue outlook, commercial priorities for its two marketed products, and upcoming clinical catalysts during a fireside chat at the TD Health Care Conference.
2028 net sales outlook driven by NUPLAZID and DAYBUE
Management reiterated guidance projecting $1.7 billion in net sales by 2028, split between NUPLAZID at $1.0 billion and DAYBUE at $700 million.
NUPLAZID commercial strategy: expanded field force and earlier patient reach
ACADIA said it has increased its NUPLAZID field force by about 30%, with the team in place in the first quarter and expected to have more impact in the back half of the year. The company is also expanding its target list from about 7,000 physicians to 11,000, adding roughly 4,000 new physicians.
Executives said the incremental targets include neurologists the company had not previously called on, as well as an increased focus on primary care physicians. ACADIA stated it is seeing more patients enter through the PCP route and that these providers may see patients earlier in their psychosis journey, when treatment may be more appropriate. Management also noted that 40% of scripts last year came from new writers, and the company aims to support continued growth from those prescribers as it moves toward 2026.
Remlifanserin (ACP-204): Phase II Alzheimer’s disease psychosis readout expected Aug.–Oct.
ACADIA discussed its next-generation 5-HT2A inverse agonist, remlifanserin (also referred to as ACP-204), with top-line Phase II data expected in a narrowed window of August to October.
Company leaders contrasted the new program with the prior HARMONY study for pimavanserin. They described HARMONY as a randomized-withdrawal, double-blind study in dementia-related psychosis across multiple dementia subtypes, with the primary endpoint of relapse defined in part using the SAPS H+D scale (hallucinations and delusions).
In contrast, remlifanserin’s Phase II program focuses on Alzheimer’s disease psychosis, with diagnosis confirmed using biomarkers, clinical criteria, and psychotic symptoms. The global Phase II portion uses a randomized, double-blind, placebo-controlled, parallel-group design. Patients are assigned to 60 mg, 30 mg, or placebo for six weeks, with a primary endpoint of SAPS H+D at week six. ACADIA said it expects to enroll around 300 patients.
Management clarified that the study begins statistical testing with the 60 mg dose, and that success would be declared if one dose is positive. Executives also emphasized that there is currently nothing approved for Alzheimer’s disease psychosis, and therefore “no established precedent,” though they said SAPS H+D is fit-for-purpose, sensitive to change, and supported by prior pimavanserin data.
When asked about what constitutes Phase II success beyond a single p-value, executives said they would evaluate the totality of the package, including efficacy consistent with the target product profile and safety/tolerability considerations such as once-daily dosing, no meaningful drug-drug interactions with commonly used medications in older patients, and no cognitive or motor side effects. They also referenced secondary measures including response thresholds (e.g., 30% or 50% improvement) and CGI-I. If results are highly statistically significant in a dataset of over 300 patients, management said it would be interested in conversations with FDA regarding what Phase III could look like in light of external agency communications around faster pathways, while noting it is difficult to speculate in advance.
Lewy body dementia study rationale and supporting pimavanserin evidence
ACADIA also discussed a Phase II study in Lewy body dementia that will enroll patients across Parkinson’s disease dementia and dementia with Lewy bodies, citing both biological and clinical rationale.
Executives described Lewy body dementia as an umbrella term with shared pathology involving misfolded alpha-synuclein, which they said disrupts serotonin signaling and upregulates 5-HT2A receptors, supporting the mechanism for a 5-HT2A inverse agonist. On clinical evidence, the company referenced:
- A pimavanserin pivotal trial in Parkinson’s disease psychosis that included 50 patients with cognitive impairment at baseline, which management said supported a label update for use “with or without dementia,” and showed a “large delta” versus placebo in that subgroup.
- The HARMONY randomized-withdrawal study, which included 46 patients with Lewy body dementia; management stated that 55% relapsed on placebo versus approximately 5% on pimavanserin.
DAYBUE growth drivers, STIX launch, and European regulatory update
For DAYBUE, ACADIA said it is guiding to $460 million to $490 million this year and expects roughly 20% growth. Management said current penetration in the U.S. community setting is about 27%, with plans to reach the early 30s by year-end, driven by an expanded field force implemented last year that can reach more neurologists who may each have one or two patients.
Executives highlighted the launch of DAYBUE STIX, a new formulation intended to provide families with more options, including potentially lower volume dosing and formulation changes such as less carbohydrate and decreased Red Dye 40. They said STIX may help:
- Enable choice for new patients based on formulation preferences.
- Support switching for current patients.
- Potentially bring back some patients who previously discontinued due to volume and/or taste.
Management said tolerability is expected to be similar between formulations, noting STIX was approved based on a bioequivalent study. The company estimated about 400 incremental additional patients could be unlocked through the 2028 timeframe due to the new formulation.
On Europe, the company said the CHMP negative opinion was formally published on Friday, consistent with expectations, and was based on the committee’s view that the RSBQ and CGI endpoints were not clinically meaningful. Executives said the reexamination strategy will focus on clinical meaningfulness by “bringing the data to life,” including examples of functional improvements, and will incorporate additional voices now available through European experience with DAYBUE via named patient programs. Management said it plans to apply for reexamination within the next couple of weeks and described the process as roughly 120 days end-to-end if it proceeds as expected, with opportunities to include patient voice during data repackaging and at scientific advisory and oral explanation steps.
ACP-211 depression program: oral ketamine metabolite in Phase II
Finally, ACADIA reviewed ACP-211 in depression, describing it as a major metabolite of ketamine. Executives differentiated IV ketamine and SPRAVATO as dissociative anesthetics with limitations including dose constraints and delivery routes (IV due to poor oral bioavailability and intranasal for SPRAVATO). They said ACP-211 is orally bioavailable and may allow a broader dose range, with goals of a better patient experience, lower dissociation, and no psychotomimetic effects while aiming for similar efficacy if the program succeeds.
The Phase II study is a U.S.-only, randomized, double-blind, placebo-controlled trial enrolling about 150 patients with major depressive disorder and inadequate response to antidepressants, including a subpopulation of treatment-resistant depression. Patients will receive ACP-211 as monotherapy at 600 mg, 300 mg, or placebo for four weeks, with the primary endpoint of MADRS at week four. Management said recruitment had just started and the company had not yet provided a firm data timeline.
About ACADIA Pharmaceuticals (NASDAQ:ACAD)
ACADIA Pharmaceuticals Inc is a biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders. Established in 1993 and headquartered in San Diego, California, ACADIA’s research centers concentrate on conditions with significant unmet medical needs, including Parkinson’s disease psychosis, Alzheimer’s disease psychosis, and schizophrenia. The company utilizes a range of scientific platforms, including selective receptor modulation and precision-targeted compounds, to advance its portfolio of small-molecule therapeutics.
The company’s flagship product, NUPLAZID® (pimavanserin), received U.S.
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