Acadia Pharmaceuticals Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare Conference

SAN DIEGO—(BUSINESS WIRE)—Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced multiple business updates and progress on the Company's neurological and rare disease drug candidates, which will be discussed today during a presentation by Catherine Owen Adams, Chief Executive Officer, at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

“2026 marks a pivotal year for Acadia as we advance our strategy built for sustained growth and pipeline advancement,” said Catherine Owen Adams, Chief Executive Officer. “With approximately $1.7 billion in global projected net sales by 2028, our commercial engine anchored by NUPLAZID and DAYBUE, continues to gain momentum. The introduction of DAYBUE STIX in the U.S. represents an exciting opportunity to deliver a more flexible option for patients and caregivers, further strengthening our leadership position in Rett syndrome care. Coupled with the anticipated Phase 2 readout of remlifanserin in Alzheimer’s disease psychosis later this year, Acadia is well-positioned to capture significant value across both our commercial portfolio and pipeline.”

Key Milestones

• Strong commercial growth outlook projecting approximately $1.7 billion in net sales in 2028, with NUPLAZID contributing ~$1 billion and DAYBUE ~$700 million.

• Top-line results from the Phase 2 RADIANT study of remlifanserin (formerly ACP‑204) in Alzheimer’s disease psychosis (ADP), expected in the August to October 2026 timeframe.

• Remlifanserin expected to account for approximately $4 billion of the $11 billion unadjusted full peak sales opportunity represented by its current pipeline, attributable to remlifanserin in both Alzheimer’s disease psychosis and Lewy body dementia psychosis.

• DAYBUE STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation approved by the U.S. FDA on December 12, 2025, for the treatment of Rett syndrome in adult and pediatric patients 2 years and older, will be available on a limited basis starting in the first quarter of 2026, with a broader launch planned for Q2 2026.

• Ministry of Health in Israel recently approved DAYBUE oral solution for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older and weighing at least 9 kg, further expanding global access to this treatment.

• Opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for trofinetide expected in the first quarter of 2026.

• Top-line results of Phase 3 study in Japan of trofinetide for the treatment of Rett syndrome anticipated in between October 2026 and March 2027.

• R&D pipeline advancing with plans to initiate five Phase 2 or Phase 3 studies across eight disclosed programs and deliver four Phase 2 or Phase 3 readouts by the end of 2027.

Today’s presentation will take place at 9:45 a.m. Pacific Time / 12:45 p.m. Eastern Time. A live webcast of the presentation will be accessible on the company’s website, acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following the presentation.

About NUPLAZID^® (pimavanserin)

Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID.

About DAYBUE^®(trofinetide)

Trofinetide is a synthetic version of a naturally occurring molecule known as the tripeptide glycine-proline-glutamate (GPE). The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. Trofinetide was approved for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older by the U.S. Food and Drug Administration in March 2023 under the trade name DAYBUE.

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” “guidance,” “continue” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities, including support for and innovations in our pipeline assets and business development opportunities, NUPLAZID and DAYBUE (including DAYBUE STIX) sales growth, and potential for enhanced shareholder value; (ii) plans for, including timing, development and progress of clinical, commercialization or regulatory timelines for our products, including NUPLAZID and DAYBUE, and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of our products; (iv) the timing and conduct of, and expected results from, our clinical trials; and (v) our estimates regarding our future financial performance, product sales, profitability, capital requirements or expenses, including our projected net sales estimates for 2028. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependency on the continued successful commercialization of our products and our ability to maintain or increase sales of our products; our plans to continue commercial growth; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; the risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-K for the year ended December 31, 2024 as well as our subsequent filings with the Securities and Exchange Commission from time to time, including our quarterly report on Form 10-Q for the quarter ended September 30, 2025. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.