ACAD ACADIA Pharmaceuticals Inc.

51.61
+1.32  (+3%)
Previous Close 50.29
Open 50.91
52 Week Low 21.56
52 Week High 53.75
Market Cap $8,044,005,461
Shares 155,861,373
Float 88,092,769
Enterprise Value $7,195,861,448
Volume 1,086,943
Av. Daily Volume 1,586,363
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Upcoming Catalysts

Drug Stage Catalyst Date
Pimavanserin - CLARITY-2 and CLARITY-3
Adjunctive Treatment in Patients With Major Depressive Disorder
Phase 3
Phase 3
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Trofinetide
Rett Syndrome
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Pimavanserin - Harmony
Alzheimer’s disease psychosis
sNDA Filing
sNDA Filing
Phase 3 trial stopped early after meeting primary endpoint - September 9, 2019. sNDA filing announced June 15, 2020.
Pimavanserin - Advance
Adjunctive treatment in patients with negative symptoms of schizophrenia
Phase 2
Phase 2
Phase 2 data released November 25, 2019. Primary endpoint met. Key secondary missed. Further pivotal trial to be initiated 2H 2020.
Pimavanserin - Enhance
Adjunctive treatment of schizophrenia
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - July 22, 2019.
Pimavanserin
Parkinson’s disease psychosis (PDP)
Approved
Approved
Approved April 29 2016. Additional dose approval announced June 29, 2018.
Pimavanserin - SERENE
Alzheimer’s disease agitation
Phase 2
Phase 2
Announced October 4, 2017 that trial will be discontinued.

Latest News

  1. - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 fold reduction in the risk of relapse of psychosis

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.

    "This is an important step forward for the approximately 2.4 million people in the U.S. who…

    - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 fold reduction in the risk of relapse of psychosis

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.

    "This is an important step forward for the approximately 2.4 million people in the U.S. who suffer from dementia-related hallucinations and delusions, representing a large unmet need with currently no approved treatment options," said Steve Davis, ACADIA's Chief Executive Officer. "Our pivotal HARMONY study showed a meaningful reduction of the symptoms and stabilization of psychosis and a nearly three-fold reduction in the risk of relapse of psychosis for patients continuing treatment on pimavanserin compared to placebo. We look forward to working with the FDA as it reviews our submission."

    The sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023). The sNDA also includes positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints: The Phase 2 (-019) study in patients with Alzheimer's disease psychosis and the Phase 3 (-020) study in patients with Parkinson's disease psychosis. The sNDA includes a large safety and tolerability database from completed and ongoing studies representing over 1500 patients with neurodegenerative disease.

    Dementia is highly prevalent, affecting approximately 8 million people in the U.S., and is only expected to grow as the population ages. Approximately 30 percent, or 2.4 million people, experience dementia-related psychosis and only half, or 1.2 million, are diagnosed and treated1,2.

    NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson's disease psychosis. If approved by the FDA, NUPLAZID would be the first drug approved to treat the hallucinations and delusions associated with dementia-related psychosis and would be the second indication for NUPLAZID.

    About HARMONY

    HARMONY was a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis across a broad population of patients with the most common clinically diagnosed subtypes of dementia including: Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders. A total of 392 patients were enrolled in the study, with an average age of 74.5 years and a mean Mini-Mental State Examination (MMSE) score of 16.7. The primary endpoint in the study was time to relapse in the double-blind period as represented by the Kaplan-Meier curve and the hazard ratio. Top-line results were presented at the 2019 Clinical Trials on Alzheimer's Disease (CTAD) Meeting in December 2019.

    The HARMONY study included a 12-week open-label stabilization period during which patients with dementia-related psychosis began treatment with pimavanserin 34 mg once daily. In the open-label period, a significant majority (61.8%) of eligible subjects (N=351) met the sustained treatment response criteria at Week 8 and Week 12 and entered the double-blind period. Following the open-label period, patients who met pre-specified criteria for treatment response were then randomized into the double-blind period of the study to continue their pimavanserin dose (34 mg or 20 mg per day) or switched to placebo and followed for up to 26 weeks or until a relapse of psychosis occurred. Pimavanserin met its primary endpoint and was stopped at the pre-planned interim analysis for positive efficacy, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023).

    Pimavanserin was well-tolerated over the entire nine-month study duration, and pimavanserin treatment was not associated with a decline in cognition, as measured by the MMSE score, or the onset or worsening of extrapyramidal symptoms, as measured by the Extrapyramidal Symptom Rating Scale A (ESRS-A) score, compared to placebo. In the double-blind period, low rates of adverse events were observed, 41.0% of patients on pimavanserin and 36.6% on placebo. Discontinuations in the double-blind period due to adverse events were low, 2.9% for pimavanserin and 3.6% for placebo. Rates of serious adverse events were also low, 4.8% in the pimavanserin group and 3.6% in the placebo group. One death was reported in the open-label period and one death was reported in the pimavanserin group during the double-blind period. Investigators determined neither death was related to the study drug.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.3 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, including hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions1,2. These symptoms may be frequent and severe and may recur over time. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality4.

    About 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 psychosis, schizophrenia, depression and other neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. ACADIA is evaluating pimavanserin in an extensive clinical development program in multiple indications with significant unmet need, including dementia-related psychosis, major depressive disorder, and negative symptoms of schizophrenia. 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®. NUPLAZID is not approved for dementia-related psychosis, schizophrenia or major depressive disorder.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, the negative symptoms of schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to pimavanserin as a potential treatment for the hallucinations and delusions associated with dementia-related psychosis and other statements that are not historical facts. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, and approval and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    Indication

    NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Important Safety Information

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • Warnings and Precautions: QT Interval Prolongation
      • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Dosage and Administration

    Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please read the full Prescribing Information including Boxed WARNING.

    References

    1Plassman BL, et al. Prevalence of dementia in the United States: the Aging Demographics, and Memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    22017 Alzheimer's Disease Facts and Figures and ACADIA market research.

    3Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

    4Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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  2. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Tuesday, June 9, 2020, at 4:40 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through July 9, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference on Tuesday, June 9, 2020, at 4:40 p.m. Eastern Time.

    The conference will be held virtually. A live webcast of ACADIA's presentation will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website through July 9, 2020.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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  3. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today announced that Mark Schneyer has been appointed to the newly created position of Senior Vice President, Business Development and Chief Business Officer. Mr. Schneyer will be responsible for sourcing and executing business development opportunities and serve as a member of the company's Executive Management Committee. He will report to Steve Davis, Chief Executive Officer.

    "I am very excited to welcome Mark to ACADIA as his extensive experience in the biopharmaceutical industry will be a valuable addition as we continue to expand our pipeline through business development," said Mr. Davis. "We remain focused on leveraging our research and development and commercial expertise as we advance…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today announced that Mark Schneyer has been appointed to the newly created position of Senior Vice President, Business Development and Chief Business Officer. Mr. Schneyer will be responsible for sourcing and executing business development opportunities and serve as a member of the company's Executive Management Committee. He will report to Steve Davis, Chief Executive Officer.

    "I am very excited to welcome Mark to ACADIA as his extensive experience in the biopharmaceutical industry will be a valuable addition as we continue to expand our pipeline through business development," said Mr. Davis. "We remain focused on leveraging our research and development and commercial expertise as we advance our business development strategies to position ACADIA for long-term growth."

    Mr. Schneyer joins ACADIA from Pfizer Inc. where he most recently was Vice President, Business Development, for the Upjohn division. Mr. Schneyer joined Pfizer's Worldwide Business Development organization in 2011 and served in various business development positions of increasing responsibility overseeing strategic transactions spanning licensing agreements, product acquisitions and divestitures, strategic collaborations and company acquisitions. Prior to Pfizer, he was an investment banker at Lazard and advised boards of directors and senior management teams in the healthcare sector. Mr. Schneyer earned a Bachelor of Science in economics with a concentration in finance from the Wharton School of the University of Pennsylvania.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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  4. - Top-line results expected in 3Q20

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that following positive feedback from the U.S. Food and Drug Administration the company plans to combine its CLARITY-2 and CLARITY-3 Phase 3 studies evaluating pimavanserin for the adjunctive treatment of major depressive disorder (MDD) into one study with a pre-specified statistical analysis plan. As a result, no new patients will be enrolled in the two identically designed Phase 3 studies, each of which will be concluded with slightly more than 50% enrollment. Top-line results from the combined study are expected in the third quarter of 2020.

    If positive, the results from the combined study, along with the positive results from the previously…

    - Top-line results expected in 3Q20

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that following positive feedback from the U.S. Food and Drug Administration the company plans to combine its CLARITY-2 and CLARITY-3 Phase 3 studies evaluating pimavanserin for the adjunctive treatment of major depressive disorder (MDD) into one study with a pre-specified statistical analysis plan. As a result, no new patients will be enrolled in the two identically designed Phase 3 studies, each of which will be concluded with slightly more than 50% enrollment. Top-line results from the combined study are expected in the third quarter of 2020.

    If positive, the results from the combined study, along with the positive results from the previously announced pivotal CLARITY study, would form the basis for a supplemental new drug application for pimavanserin in the adjunctive treatment of MDD.

    About CLARITY-2 and CLARITY-3

    CLARITY-2 and CLARITY-3 are both 6-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD who have an inadequate response to standard antidepressant therapy with either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). Patients in both studies were randomized to receive six weeks of oral treatment with either 34 mg of pimavanserin or placebo, once daily, in addition to their ongoing antidepressant. The primary endpoint in both studies is the change from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.

    Patients who completed the Phase 3 studies were eligible to participate in the ongoing 52-week open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in MDD. The open-label extension study is continuing as planned.

    About CLARITY

    CLARITY was a Phase 2, 10-week, randomized, double-blind, placebo-controlled, multi-center, 2-stage sequential parallel comparison design (SPCD) study that evaluated the safety, tolerability, and efficacy of pimavanserin (34 mg once daily) as an adjunctive treatment in patients with MDD who had an inadequate response to a stable dose of standard antidepressant therapy with either a SSRI or a SNRI. The study was conducted in collaboration with the Massachusetts General Hospital Clinical Trials Network & Institute and randomized 207 patients across 27 clinical research centers in the U.S.

    In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing the HAMD-17 total score compared to placebo (p=0.039). On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004). Positive results were also observed for seven other secondary endpoints including the Karolinska Sleepiness Scale (p=0.0205) and the Massachusetts General Hospital Sexual Functioning Index (p=0.0003).

    In the parallel design portion (Stage 1) of this SPCD study, adding pimavanserin to first-line SSRI or SNRI therapy also significantly reduced HAMD-17 scores compared to placebo (p=0.0003). On the key secondary endpoint, pimavanserin also demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004).

    About Major Depressive Disorder

    According to the National Institute of Mental Health, MDD affects approximately 17 million adults in the U.S.1, with approximately 2.5 million adults treated with adjunctive therapy.2,3 MDD is a condition characterized by depressive symptoms such as a depressed mood or a loss of interest or pleasure in daily activities for more than two weeks, as well as impaired social, occupational, or other important functioning. The majority of people who suffer from MDD do not respond adequately to initial antidepressant therapy.4

    About 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 psychosis, schizophrenia, depression and other neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, adjunctive major depressive disorder, and the negative symptoms of schizophrenia. 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®. NUPLAZID is not approved for dementia-related psychosis, schizophrenia or major depressive disorder.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to the potential benefits of pimavanserin as adjunctive treatment for major depressive disorder or other central nervous system disorders as well as the potential results of clinical trials of pimavanserin in other indications. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • QT Interval Prolongation: NUPLAZID prolongs the QT interval.
      • The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Indication: NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Dosage and Administration: Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please see the full Prescribing Information including Boxed WARNING for NUPLAZID.

    References:

    1National Institute of Mental Health. (2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

    2IMS NSP, NPA, NDTI MAT-24 month data through Aug 2017.

    3PLOS One, Characterization of Treatment Resistant Depression Episodes in a Cohort of Patients from a US Commercial Claims Database, Oct 2013, Vol 8, Issue 10.

    4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).

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  5. ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting on May 29-30, 2020.

    "Our research presentations at ASCP underscore the potential clinical utility of pimavanserin in serious CNS disorders," said Serge Stankovic, M.D., M.S.P.H., ACADIA's President. "We look forward to sharing data from our pivotal studies in negative symptoms of schizophrenia and major depressive disorder where pimavanserin has demonstrated the potential to be an important treatment option for…

    ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting on May 29-30, 2020.

    "Our research presentations at ASCP underscore the potential clinical utility of pimavanserin in serious CNS disorders," said Serge Stankovic, M.D., M.S.P.H., ACADIA's President. "We look forward to sharing data from our pivotal studies in negative symptoms of schizophrenia and major depressive disorder where pimavanserin has demonstrated the potential to be an important treatment option for patients, as well as new long-term safety and tolerability data of NUPLAZID® in Parkinson's disease psychosis."

    ASCP Accepted Scientific Presentations include:

    Negative Symptoms of Schizophrenia

    • Pharmaceutical Pipeline Oral Presentation: ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Negative Symptoms of Schizophrenia on Saturday, May 30, 2020, 4:55 p.m. - 5:05 p.m. Eastern Time.
    • Poster Presentation: ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Negative Symptoms of Schizophrenia on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.

    Depression

    • Poster Presentation: Effect of Adjunctive Pimavanserin on Suicidality in Patients with Major Depressive Disorder: Secondary Analysis from CLARITY on Friday, May 29, 2020, 12:30 p.m. - 2:00 p.m. Eastern Time.
    • Poster Presentation: Effect of Adjunctive Pimavanserin on Insomnia and Function in Patients with Major Depressive Disorder: Secondary Analysis from CLARITY on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.
    • Poster Presentation: Pimavanserin for the Treatment of Comorbid Depression in Patients with Parkinson's Disease on Friday, May 29, 2020, 12:30 p.m. - 2:00 p.m. Eastern Time.

    Parkinson's Disease Psychosis

    • Poster Presentation: Long-Term Evaluation of Open-Label Pimavanserin Safety and Tolerability in Parkinson's Disease Psychosis on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.
    • Poster Presentation: Improvement and Durability in SAPS-PD Assessment over 10 Weeks of Pimavanserin Treatment for Parkinson's Disease Psychosis on Saturday, May 30, 2020, 12:45 p.m. - 2:15 p.m. Eastern Time.

    About 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 psychosis, schizophrenia, depression and other neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, adjunctive major depressive disorder, and the negative symptoms of schizophrenia. 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®. NUPLAZID is not approved for dementia-related psychosis, schizophrenia, major depressive disorder or depression in patients with Parkinson's disease.

    About ACADIA Pharmaceuticals

    ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, major depressive disorder, the negative symptoms of schizophrenia, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

    Forward-Looking Statements

    Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential benefits of pimavanserin as adjunctive treatment for major depressive disorder, the negative symptoms of schizophrenia or other central nervous system disorders as well as the potential results of clinical trials of pimavanserin in other indications. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2019 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    Important Safety Information and Indication for NUPLAZID (pimavanserin)

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
    • NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
    • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
    • QT Interval Prolongation: NUPLAZID prolongs the QT interval.
      • The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
      • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
    • Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
    • Drug Interactions:
      • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
      • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

    Indication: NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

    Dosage and Administration: Recommended dose: 34 mg capsule taken orally once daily, without titration.

    NUPLAZID is available as 34 mg capsules and 10 mg tablets.

    Please see the full Prescribing Information including Boxed WARNING for NUPLAZID.

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