ACADIA Pharmaceuticals Targets $1B Brand Opportunity as Key Neuropsychiatry Data Looms

ACADIA Pharmaceuticals (NASDAQ:ACAD) executives said the company is focused on expanding its two commercial brands while preparing for several clinical data readouts in neuropsychiatric disorders, according to comments at the Bank of America Global Healthcare Conference.

Chief Executive Officer Catherine Owen Adams, who has been in the role for just over 18 months, said her initial priorities were to stabilize ACADIA’s commercial business and identify new growth opportunities. She said the company has reassessed the potential for both NUPLAZID and DAYBUE, including changes to sales force sizing and commercial strategy.

“As a result of that improved marketing, we were able to guide to almost a $1 billion opportunity for both commercial brands by 2028,” Owen Adams said.

NUPLAZID Growth Strategy Centers on Wider Physician Reach

Owen Adams said ACADIA believes it can drive additional growth for NUPLAZID, which is used in Parkinson’s disease psychosis. She said outside peak-sales estimates had previously been in the $650 million to $700 million range, but the company is now guiding to $1 billion in 2028.

The company increased the NUPLAZID field force by 30%, with a goal of reaching about 4,000 to 5,000 new physicians. Owen Adams said ACADIA is targeting a broader group of prescribers beyond neurologists, including primary care physicians, nurse practitioners and physician assistants who treat patients with Parkinson’s disease.

She also highlighted ACADIA’s direct-to-consumer efforts, including an unbranded campaign featuring Ryan Reynolds, which she said led to a fourfold increase in awareness of hallucinations and delusions among caregivers. A new campaign is expected to launch next week, she said.

Owen Adams said NUPLAZID has roughly 20% to 25% share, depending on how the market is defined, and ACADIA believes it can expand beyond that level.

On intellectual property, Owen Adams said ACADIA has composition-of-matter protection to October 2030 and method-of-use protection to 2038. She said the company is viewing NUPLAZID’s runway through 2038, though it expects Medicare price reductions under the Inflation Reduction Act in the 2029 to 2031 timeframe. She added that ACADIA qualifies for the small company benefit, allowing it to step into those reductions over the first two years.

DAYBUE Launch Adjustments Focus on Persistence and New Formulation

For DAYBUE, ACADIA’s therapy for Rett syndrome, Owen Adams said the company increased its field force after determining it was not reaching enough community physicians. She noted that 65% of Rett patients are treated outside centers of excellence.

ACADIA has also evolved its patient-support model, focusing on the patient journey before a prescription starts and continuing beyond initiation. Owen Adams said the company has increased education through family support educators and medical science liaisons.

She said the company has seen stabilization after early post-launch discontinuations tied to gastrointestinal side effects. ACADIA has published a white paper on patient titration and now reports a 55% persistency rate at 12 months, which she said has increased slightly since she joined the company.

Owen Adams also discussed DAYBUE STIX, a powder for oral solution. She said it does not require refrigeration, can be mixed with liquids other than dairy, uses about half the volume of the liquid formulation, and removes Red Dye 40 and maltitol.

According to Owen Adams, ACADIA is seeing interest from three groups: patients switching from the liquid formulation, new patients who had not started DAYBUE because of maltitol or Red Dye 40, and patients who previously discontinued DAYBUE and are now returning to try DAYBUE STIX. She said ACADIA recorded 250 prescriptions for DAYBUE STIX in the first quarter, with 30% coming from patients new to DAYBUE or restarting therapy and 70% from switchers. The company has guided to about 450 incremental patients over three years from the powder formulation and is tracking slightly ahead of that pace, she said.

Remlifanserin Data Expected Later This Year

Head of Research and Development Liz Thompson discussed ACP-204, or remlifanserin, a drug being studied for Alzheimer’s disease psychosis. Top-line phase 2 data are expected between August and October of this year.

Thompson described remlifanserin as a “cousin” of pimavanserin, the active ingredient in NUPLAZID, informed by prior pimavanserin data. She said NUPLAZID has a QT prolongation signal that limited dose exploration, while remlifanserin may allow higher exposures and has a faster time to steady state.

The Alzheimer’s disease psychosis phase 2 trial is placebo-controlled and includes three arms: placebo, 30 milligrams and 60 milligrams. Thompson said the lower dose is roughly equivalent to the exposure of the marketed NUPLAZID dose, while the higher dose is about twice that exposure. The primary endpoint is the SAPS-H+D score at week six, focused on hallucinations and delusions.

Thompson said ACADIA expects to disclose at least the primary endpoint result and general safety commentary when the data are released. She said the study is powered at 80% for a 0.4 effect size, which she described as a moderate effect size, and that a somewhat lower effect size could still be clinically meaningful.

The company has a master protocol that covers the phase 2 trial and two phase 3 studies. Thompson said the program is operationally seamless, meaning phase 3 enrollment can begin after phase 2 enrollment stops, while the studies remain statistically separate. ACADIA may modify the phase 3 design based on phase 2 results, potentially including dose selection, sample size or endpoints, she said.

Lewy Body Dementia and Depression Programs Advance

Thompson said ACADIA is also studying remlifanserin in Lewy body dementia psychosis, an indication she described as an important opportunity with substantial unmet need. She said about 1 million patients have Lewy body dementia, and 50% to 75% experience psychosis during their disease course. Current treatment is largely off-label antipsychotic use, which can be problematic given motor and cognitive effects, she said.

Thompson also outlined ACP-211, ACADIA’s selectively deuterated R-ketamine, which is in a phase 2 trial for major depressive disorder. She said the goal is “ketamine-like efficacy with a different patient experience,” citing preclinical data suggesting efficacy without sedation and early phase 1 data showing no sedation and only low levels of dissociation at the highest doses in healthy volunteers. A proof-of-concept readout is expected around mid-year next year.

Owen Adams said the oral nature of ACP-211 could be an additional benefit and emphasized that patient experience will be important in a market with multiple competing mechanisms under development.

Asked about possible staffing changes at the FDA, Thompson said greater agency stability would be beneficial for the biotech sector broadly. For ACADIA specifically, she said the company has had consistent review teams for much of its portfolio, particularly later-stage programs in the Division of Psychiatry, and is not currently expecting a company-specific impact.

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.