Pimavanserin tartrate

-- Meaningful and consistent efficacy trends across endpoints support continuing with Phase 3 development of 60 mg once daily remlifanserin in ADP, with demonstrated evidence of dose effect -- Narrowly missed primary endpoint of SAPS H+D (p=0.0603) with significance (nominal) on key secondary endpoint of CGI-S-ADP (p=0.0077) -- Favorable safety and tolerability pro both doses -- Detailed results to be presented at upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference in November -- Conference call and webcast to be held today at 8:00 a.m. Eastern Time SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced Phase 3 enabling topline results from the Phase 2 portion of the ongoing RADIANT clinical trial program evaluating remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). For the primary endpoint of change from baseline in the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D), once daily 60 mg remlifanserin demonstrated a change of -12.6 versus a -10.4 change for placebo at week 6, yielding a standardized effect size of 0.26 (p=0.0603). For the key secondary endpoint, Clinical Global Impression – Severity (CGI-S-ADP), the 60 mg dose achieved a change from baseline of -1.3 versus a change of -0.9 for placebo at week 6, yielding a standardized effect size of 0.37 [p=0.0077 (nominal)]. On both efficacy measures, the difference in the 60 mg dose versus placebo increased through the 6-week treatment period. The 30 mg dose showed minimal improvement across endpoints compared to placebo. All analyses were performed in the pre-specified modified full analysis set (mFAS 1 ) population. In this study, across both doses, remlifanserin demonstrated a favorable safety profile, with rates of adverse events, serious adverse events, and discontinuations due to adverse events, similar to placebo. There was no signal of QT prolongation versus placebo. This dataset suggests no negative impact on motor symptoms or cognition. Additionally, there were no deaths in the remlifanserin treatment arms. Given these data, Acadia plans to continue enrolling its two ongoing Phase 3 studies evaluating remlifanserin in ADP while implementing amendments to the Phase 3 program, including removing the 30 mg dosage arm. “We are pleased that the Phase 2 RADIANT data support continuation of the Phase 3 ADP program, with new insights helping us to refine the program for future regulatory success. These results provide valuable information regarding the efficacy, safety and tolerability of once daily remlifanserin in Alzheimer’s disease psychosis,” said Catherine Owen Adams, Chief Executive Officer of Acadia Pharmaceuticals. “We are excited about the potential of remlifanserin in this area of high unmet need, for which there are no currently approved therapies.” “The Phase 2 RADIANT findings provide encouraging evidence that 60 mg once daily remlifanserin may have the potential to reduce hallucinations and delusions in patients with Alzheimer’s disease,” said Jeffrey Cummings, M.D., Sc.D., Director of the Chambers-Grundy Center for Transformative Neuroscience, University of Nevada, Las Vegas. “This patient population has a significant need for an efficacious medication that is well tolerated, convenient to administer, and is compatible with the many concomitant medications commonly used by patients with Alzheimer’s disease. In particular, avoiding negative impacts on motor symptoms and cognition is encouraging, and such a medicine could be an important treatment option for patients.” Acadia plans to present detailed safety and efficacy results from the RADIANT Phase 2 study in an oral presentation at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference, taking place November 16-19, 2026 in Boston. Additionally, remlifanserin is currently being investigated in an additional Phase 2 study to evaluate its efficacy, safety and tolerability for the treatment of Lewy body dementia psychosis. Conference Call and Webcast Information Acadia will discuss top-line results from its Phase 2 RADIANT study of remlifanserin for the treatment of Alzheimer’s disease psychosis via conference call and webcast today at 8:00 a.m. Eastern Time. The conference call webcast is available at this registration link and will be available on Acadia’s website, acadia.com under the investors section and will be archived there for at least 90 days following the event. About RADIANT RADIANT is a global, multi-center, randomized, double-blind, placebo-controlled, operationally seamless Phase 2 and 3 clinical trial program evaluating remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The Phase 2 portion of the program was designed to evaluate the efficacy, safety, and tolerability of remlifanserin at 60 mg and 30 mg once-daily doses compared with placebo. Patients who complete the study will have the option of participating in a long-term open-label extension (OLE) study. About Alzheimer’s Disease Psychosis According to the Alzheimer’s Association, more than 7 million people in the United States are living with Alzheimer’s disease (AD). 2,3 Approximately 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions. 4 These symptoms may be frequent and severe and may recur over time. 5 A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed, smelled) in nature. A delusion is defined as a false, fixed belief despite evidence to the contrary. Serious consequences have been associated with psychosis in patients with dementia, such as increased likelihood of nursing home placement, more severe dementia, and increased risk of morbidity and mortality. 6,7 There is no FDA-approved drug for the treatment of Alzheimer’s disease psychosis. About Remlifanserin Remlifanserin is a novel, highly selective 5HT2A receptor inverse agonist being developed to treat Alzheimer’s disease psychosis and Lewy body dementia psychosis. 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 “intends,” “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” 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 clinical development plans to continue the Phase 3 portion of the program related to remlifanserin in Alzheimer’s disease psychosis and the Phase 2 study of remlifanserin in Lewy body dementia psychosis, (ii) our plans to implement protocol amendments to the Phase 3 portion of the program, and (iii) the safety pro remlifanserin, and the potential benefits that remlifanserin could provide to patients suffering with psychosis associated with Alzheimer’s disease. 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, assumptions and other factors include, but are not limited to: risks associated with the discovery, development and regulation of pharmaceutical products in general; risks that our future clinical trials may not support approval of our product candidates; risks that future clinical trial results may not be consistent with interim, initial, preliminary or topline results or results from prior preclinical studies or clinical trials; our dependency on the continued successful commercialization of Nuplazid (Pimavanserin) and Daybue (Trofinetide) and our ability to maintain or increase sales of Nuplazid and Daybue; our ability to generate or obtain the necessary capital to fund our clinical development plans; the timing and results of our clinical trials; 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, assumptions and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q for the period ended June 30, 2026 filed with the Securities and Exchange Commission on August 5, 2026, as well as our subsequent filings with the Securities and Exchange Commission from time to time. 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. References: 1 The Modified Full Analysis Set (mFAS) includes all randomized subjects who received at least one dose of study drug and who have a baseline SAPS-H+D total score ≥10 and at least one post-baseline value for SAPS-H+D total score. Subjects were analyzed based on their planned randomized treatment. 2 Alzheimer’s Association. 2025 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2025;21(4). 3 Rajan KB et al. Population estimate of people with clinical Alzheimer’s disease and mild cognitive impairment in the United States (2020-2060). Alzheimer’s and Dementia . 2021: 1-10. 4 Cummings J et al. Criteria for Psychosis in Major and Mild Neurocognitive Disorders: International Psychogeriatric Associations (IPA) Consensus Clinical and Research Definition. Am J of Geriatric Psychiatry . 2020; 28(12): 1256-1269. 5 Ballard C et al. A prospective study of psychotic symptoms in dementia sufferers: psychosis in dementia. Int Psychogeriatr . 1997; 9(1): 57-64. 6 Scarmeas N et al. Delusions and hallucinations are associated with worse outcome in Alzheimer Disease. Arch Neurol . 2005; 62(10): 1601-1608. 7 Peters ME et al. Neuropsychiatric symptoms as predictors of progression to severe Alzheimer’s dementia and death: the Cache County Dementia Progression study. Am J Psychiatry . 2015; 172(5): 460-465. Contacts Investor Contact: Acadia Pharmaceuticals Inc. Al Kildani (858) 261-2872 ir@acadia-pharm.com Acadia Pharmaceuticals Inc. Jessica Tieszen (858) 261-2950 ir@acadia-pharm.com Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818) 395-3043 media@acadia-pharm.com

- Second quarter DAYBUE ® GAAP net sales of $125 million, up 30% year-over-year driven by strong uptake of DAYBUE STIX - Second quarter NUPLAZID ® GAAP net sales of $183 million, up 10% year-over-year on a non-GAAP adjusted basis - Increased full year 2026 total revenue guidance to $1.24 to $1.30 billion, reflecting higher DAYBUE guidance of $480 to $510 million and reaffirmed NUPLAZID guidance of $760 to $790 million - Topline results from the Phase 2 remlifanserin study in Alzheimer’s disease psychosis anticipated September to October 2026 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the second quarter ended June 30, 2026. “Acadia delivered an outstanding second quarter, highlighted by strong commercial execution across both DAYBUE and NUPLAZID, resulting in total revenue growth of 17% year-over-year on an adjusted basis,” said Catherine Owen Adams, Chief Executive Officer of Acadia. “For DAYBUE, continued patient demand and robust uptake of STIX drove another quarter of strong performance. For NUPLAZID, we continued to see strong momentum, especially in new-to-brand prescriptions as our recently expanded sales force gained traction in the field. We remain confident that both franchises are on track to achieve our long-term ambition of approximately $1.7 billion in annual net sales in 2028. Looking ahead, we are excited about the anticipated topline results from our Phase 2 program evaluating remlifanserin in Alzheimer's disease psychosis in the September to October timeframe, which we believe represents a potentially transformational opportunity for Acadia.” Company Updates Completed enrollment in the Phase 2 portion of the RADIANT program evaluating remlifanserin in Alzheimer's disease psychosis and initiated Phase 3 screening and enrollment; topline Phase 2 results are expected in September to October 2026. Received FDA Fast Track designation for remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis, recognizing its potential to address a significant unmet medical need. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for DAYBU ® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If approved by the European Commission, DAYBU would become the first authorized treatment for Rett syndrome in the European Union. Financial Results Revenues GAAP total revenues, comprised of net product sales from NUPLAZID and DAYBUE, were $308 million for the second quarter of 2026, up 16% as compared to GAAP total revenues of $265 million in the second quarter of 2025, and up 17% as compared to non-GAAP adjusted total revenues of $262 million in the second quarter of 2025. GAAP net product sales of NUPLAZID were $183 million for the second quarter of 2026, up 9% compared to GAAP net product sales of $168 million for the second quarter of 2025, and up 10% as compared to non-GAAP adjusted net product sales of $166 million for the second quarter of 2025. Net product sales of DAYBUE were $125 million for the second quarter of 2026, an increase of 30% as compared to $96 million for the second quarter of 2025. A reconciliation of NUPLAZID non-GAAP adjusted net product sales and non-GAAP adjusted total revenues is provided in Table 1. A description of these adjustments is included under ‘Non-GAAP Financial Measures.’ Research and Development Research and development expenses for the second quarter of 2026 were $82 million, compared to $78 million for the same period of 2025. Selling, General and Administrative Selling, general and administrative expenses for the second quarter of 2026 were $160 million, compared to $134 million for the same period of 2025. Net Income For the second quarter of 2026, Acadia reported net income of $32 million, or $0.18 per diluted share, compared to a net income of $27 million, or $0.16 per diluted share, for the same period in 2025. Cash and Investments At June 30, 2026, Acadia’s cash, cash equivalents, and investment securities totaled $956 million, compared to $820 million at December 31, 2025. Full Year 2026 Financial Guidance (GAAP): Acadia is updating its 2026 guidance: Total revenues revised to a range of $1.24 to $1.30 billion, up from the previous range of $1.22 to $1.28 billion. NUPLAZID net product sales in the range of $760 to $790 million. DAYBUE (including all forms of trofinetide) global net product sales in the range of $480 to $510 million, up from the previous range of $460 to $490 million. R&D expense in the range of $355 to $380 million, down from the previous range of $385 to $410 million. SG&A expense in the range of $660 to $700 million. Conference Call and Webcast Information Acadia will host a conference call to discuss the second quarter 2026 results today, Tuesday, August 4, 2026 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed by registering for the call here . Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call. 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 or DAYBUE STIX. 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 . Non-GAAP Financial Measures This press release contains the following financial measures that do not comply with U.S. generally accepted accounting principles (GAAP): non-GAAP adjusted net product sales for NUPLAZID for the second quarter of 2025 and non-GAAP adjusted total revenues for the second quarter of 2025. In preparing these non-GAAP financial results, the Company includes adjustments made to reflect the impact of a change in estimate related to NUPLAZID IRA rebate accruals. Please refer to our press release dated February 25, 2026, for additional details. These non-GAAP financial measures complement GAAP results and are used by management to analyze financial performance and evaluate period-to-period changes. Management believes these non-GAAP financial measures are useful to investors and other users of the Company’s financial statements to facilitate period-to-period comparability. These non-GAAP financial measures are not meant to be considered as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are unlikely to be comparable with non-GAAP disclosures released by other companies. 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, sales growth for DAYBUE and uptake in DAYBUE STIX, and potential for enhanced shareholder value; (ii) the momentum and expectations for NUPLAZID with the expanded sales force, (iii) the FDA’s potential review of a new drug application for remlifanserin as a treatment for Alzheimer’s disease psychosis, (iv) the receipt and timing of the topline results of the RADIANT Phase 2 study, the transformational opportunity of those results, and the enrollment of the Phase 3 portion of the RADIANT development program, (v) potential approval of DAYBU (trofinetide) in the European Union, (vi) plans for, including timing, development and progress of commercialization or regulatory timelines for our products and our product candidates; (vii) benefits to be derived from and efficacy of our products, including the potential advantages of our products; and (viii) our estimates regarding our future financial performance, profitability, capital requirements or expenses, including our full year 2026 financial guidance and anticipated net product sales by the end of 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; the success of 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, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. 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. ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenues Product sales, net $ 307,959 $ 264,566 $ 576,021 $ 508,882 Total revenues 307,959 264,566 576,021 508,882 Operating expenses Cost of product sales (1)(2) 28,316 20,734 53,107 41,126 Research and development (2) 81,555 77,951 158,423 156,216 Selling, general and administrative (2) 160,252 133,507 331,271 259,877 Total operating expenses 270,123 232,192 542,801 457,219 (Loss) income from operations 37,836 32,374 33,220 51,663 Interest income, net 7,990 7,243 16,045 15,144 Other income 647 594 1,189 1,183 Income before income taxes 46,473 40,211 50,454 67,990 Income tax expense 14,973 13,545 15,317 22,337 Net income $ 31,500 $ 26,666 $ 35,137 $ 45,653 Earnings per share: Basic $ 0.18 $ 0.16 $ 0.21 $ 0.27 Diluted $ 0.18 $ 0.16 $ 0.20 $ 0.27 Weighted average common shares outstanding: Basic 171,603 167,827 171,063 167,321 Diluted 172,851 168,681 172,890 168,219 (1) Includes license fees and royalties (2) Includes the following stock-based compensation expense Cost of product sales $ 510 $ 18 $ 838 $ 352 Research and development $ 4,746 $ 4,477 $ 8,888 $ 7,910 Selling, general and administrative $ 11,684 $ 9,845 $ 21,912 $ 17,458 ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited) June 30, 2026 December 31, 2025 (unaudited) Assets Cash, cash equivalents and investment securities $ 956,474 $ 819,686 Accounts receivable, net 150,642 121,457 Interest and other receivables 15,688 26,774 Inventory 32,372 34,670 Prepaid expenses and other current assets 69,369 59,526 Total current assets 1,224,545 1,062,113 Property and equipment, net 17,107 7,511 Operating lease right-of-use assets 69,424 47,354 Intangible assets, net 103,448 108,893 Restricted cash 7,846 7,845 Long-term inventory 76,301 76,704 Deferred tax assets 240,679 249,879 Other assets 3,550 3,896 Total assets $ 1,742,900 $ 1,564,195 Liabilities and stockholders’ equity Accounts payable $ 44,566 $ 10,903 Accrued liabilities 316,870 266,211 Total current liabilities 361,436 277,114 Operating lease liabilities 59,547 40,554 Other long-term liabilities 15,308 19,137 Total liabilities 436,291 336,805 Total stockholders’ equity 1,306,609 1,227,390 Total liabilities and stockholders’ equity $ 1,742,900 $ 1,564,195 Table 1. ACADIA PHARMACEUTICALS INC. NON-GAAP RECONCILIATION (in millions) (Unaudited) 2Q25 2Q26 GAAP NUPLAZID Net Sales $ 168.5 $ 183.2 Allocation of 2025 Amount $ (2.4 ) $ — Non-GAAP Adjusted NUPLAZID Net Sales $ 166.1 $ 183.2 DAYBUE products Net Sales $ 96.1 $ 124.8 Non-GAAP Adjusted Total Revenues $ 262.2 $ 308.0 Contacts Investor Contact: Acadia Pharmaceuticals Inc. Al Kildani (858) 261-2872 ir@acadia-pharm.com Acadia Pharmaceuticals Inc. Jessica Tieszen (858) 261-2950 ir@acadia-pharm.com Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818) 395-3043 media@acadia-pharm.com