ACADIA Pharmaceuticals Targets $1.7B Sales by 2028, Maps Key Remlifansirin Readouts at JPM Conf

ACADIA Pharmaceuticals (NASDAQ:ACAD) used its presentation at the 44th Annual J.P. Morgan Healthcare Conference to highlight commercial momentum from its two marketed products, outline a slate of clinical milestones across neurology and rare disease, and discuss investments in capabilities such as artificial intelligence, biomarkers, and global expansion.

Commercial brands and 2028 ambition

CEO Catherine Owen Adams said ACADIA is “building a really strong foundation for growth” with two commercial brands—NUPLAZID and DAYBUE—delivering more than $1 billion in sales in 2025. For the first time, the company shared an “ambition” for the two brands to reach about $1.7 billion in 2028, comprising approximately $1.0 billion from NUPLAZID and $700 million from DAYBUE.

Adams emphasized these figures were not guidance and noted drug development and commercialization carry risks. In the Q&A, Adams said the DAYBUE trajectory assumes European approval, while NUPLAZID assumptions reflect continued growth.

NUPLAZID: awareness-building and field force expansion

Adams described Parkinson’s disease psychosis as an area with significant educational and commercial opportunity. She cited about 1 million Parkinson’s patients in the U.S., with roughly half expected to develop hallucinations and/or delusions over the course of their disease. Despite a direct-to-consumer campaign featuring Ryan Reynolds, she said awareness among patients and caregivers remains below 20%, though the campaign increased awareness from about 10% to 20%.

She noted there are about 130,000 patients treated for hallucinations and delusions with off-label antipsychotics and said NUPLAZID remains the first and only approved treatment for Parkinson’s disease hallucinations and delusions. ACADIA has treated 97,000 patients since launch and estimates it holds about a 25% share of those 130,000 treated patients. Adams also said the company has patent protection through 2038 following a successful patent defense in 2025.

To support growth, Adams said ACADIA plans to continue direct-to-consumer efforts and expand the NUPLAZID field force by about 30% starting this quarter, while using AI to support “precision execution.” Chief Commercial Officer Tom identified momentum from 2025, including new prescribers and engagement across the Parkinson’s disease psychosis community, as a platform for 2026.

DAYBUE: formulation rollout and global expansion

DAYBUE is positioned as the first and only treatment for Rett syndrome. Adams described Rett syndrome as a highly debilitating rare disease caused by mutations in the MECP2 gene, primarily affecting females. She said the company’s latest figures indicate about 6,000 diagnosed Rett patients in the U.S., up from a prior range of 5,500–5,800, representing a roughly 30% increase since DAYBUE’s launch. In Europe, ACADIA estimates a prevalent population of 9,000–12,000 patients.

Since its 2023 launch, the company has treated more than 2,000 patients, and Adams reported 55% of patients remain on therapy at 12 months. She also noted more than 300 patients are enrolled in the company’s real-world evidence Lotus study.

ACADIA said it received approval on Dec. 12 for DAYBUE Sticks, a powder-for-oral solution formulation. Adams outlined attributes including mixability with different liquids, no refrigeration, portability, and lower sugar and carbohydrate content—an important consideration for patients on ketogenic diets to help control seizures. The company plans a limited rollout through the first quarter as inventory builds, with full availability by the beginning of the second quarter.

On international expansion, Adams said DAYBUE is approved in three markets and that ACADIA announced an Israel approval the same day. She said the company anticipates a CHMP opinion in the first quarter of 2026 and has initiated a phase 3 trofinetide trial in Japan. She also said the company continues to supply DAYBUE globally through named patient programs, including patients from EU countries, the Middle East, and Latin America.

Pipeline highlights and timing

Adams and Head of R&D Liz discussed several programs, with Remlifansirin (formerly ACP-204), a 5-HT2A agonist, as a key near-term catalyst. ACADIA said it is pursuing Remlifansirin in Alzheimer’s disease psychosis (ADP) and Lewy body dementia psychosis (LBDP), and highlighted an estimated $4 billion potential peak sales opportunity across the two indications (described as illustrative rather than guidance).

• Remlifansirin in ADP: The global, double-blind, placebo-controlled phase 2 Radiant study is enrolling 318 subjects across 60 mg and 30 mg doses versus placebo, with SAPS-H+D at six weeks as the primary endpoint. Adams said top-line results from the phase 2 portion of the “operationally seamless but statistically separate” phase 2/3 program are expected between August and October of this year. Liz said the program incorporates biomarker confirmation of Alzheimer’s disease and refinements such as targeting slightly more severe psychosis at baseline. She characterized the updated timing as a refinement rather than a delay.
• Remlifansirin in LBDP: ACADIA recently initiated a global phase 2, double-blind, randomized, placebo-controlled study using the same two doses and endpoint (SAPS-H+D at six weeks), enrolling patients with Parkinson’s disease dementia psychosis and Lewy body dementia psychosis.
• ACP-211 in major depressive disorder: The company has initiated a four-week, randomized, double-blind, placebo-controlled phase 2 study enrolling 153 patients, with a primary endpoint of change in MADRS at week four. In a forward timeline slide discussion, the company referenced phase 2 results in 2027.
• ACP-711 in essential tremor: Adams said the program includes a phase 1 elderly cohort underway and projected a phase 2 initiation in the fourth quarter of 2026, with a plan to enroll 150 patients in a double-blind, placebo-controlled study.
• ACP-271 (GPR88 agonist): ACADIA plans to start a first-in-human healthy volunteer study in the first quarter of 2026 and develop the candidate for tardive dyskinesia and Huntington’s disease. Liz said ACP-271 represents the most novel biology in the pipeline and described it as the riskiest program.

Adams also said that across eight disclosed and undisclosed programs, ACADIA expects five additional phase 2 or phase 3 study starts between now and the end of 2027, along with four phase 2/3 study readouts by the end of 2027.

Investments: AI, expenses, and business development focus

Adams said ACADIA is investing in precision medicine and biomarkers across trials, data innovation and AI across the business, globalization, and patient empowerment. She said the company appointed a Chief Information and Data Officer and is leveraging AI in commercial targeting, R&D through a “clinical command center” to monitor trials, and regulatory document development.

Chief Financial Officer Mark said the company would provide expense guidance with fourth-quarter results, but anticipated an uptick in operating expenses year over year due to investments such as the NUPLAZID field force expansion, European efforts, DAYBUE Sticks, and the annualization of the DAYBUE field team expansion initiated in the second quarter of the prior year. He said the company expects operating leverage over time, with modest commercial/SG&A growth after 2026, while R&D spending will depend on pipeline advancement and business development activity.

On business development, Adams said ACADIA remains focused on neurology and rare disease, with an ambition to expand beyond neuro into other rare disease areas such as cardiac, endocrine, and metabolic conditions. She said the company is particularly interested in late-stage opportunities that could be commercialized within the next few years, while also looking at pipeline innovation, including “larger molecule” opportunities, supported by what she described as a strong balance sheet.

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.