ACAD ACADIA Pharmaceuticals Inc.

21.23
-0.54  -2%
Previous Close 21.77
Open 21.5
52 Week Low 19.2
52 Week High 58.72
Market Cap $3,400,600,934
Shares 160,179,036
Float 98,680,233
Enterprise Value $2,975,992,613
Volume 1,663,579
Av. Daily Volume 3,119,016
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Upcoming Catalysts

Drug Stage Catalyst Date
Trofinetide (LAVENDER)
Rett Syndrome
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ACP-044
Pain
Phase 2
Phase 2
Phase 2 trial initiated March 2021.
NUPLAZID (pimavanserin) CLARITY-2 and CLARITY-3
Adjunctive Treatment in Patients With Major Depressive Disorder
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - July 20, 2020.
NUPLAZID (pimavanserin) Advance-2
Adjunctive treatment in patients with negative symptoms of schizophrenia
Phase 3
Phase 3
Phase 3 trial initiated 3Q 2020.
NUPLAZID (pimavanserin) Enhance
Adjunctive treatment of schizophrenia
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - July 22, 2019.
NUPLAZID (pimavanserin)
Alzheimer’s disease psychosis
CRL
CRL
CRL announced April 5, 2021.
NUPLAZID (pimavanserin)
Parkinson’s disease psychosis (PDP)
Approved
Approved
Approved April 29 2016. Additional dose approval announced June 29, 2018.

Latest News

  1. - 1Q21 net sales of $106.6 million, an 18% increase over 1Q20

    - Reiterating FY21 net sales guidance of $510 to $550 million

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the first quarter ended March 31, 2021.

    "NUPLAZID delivered strong year-over-year performance in the first quarter of 2021. Looking ahead, we see positive signs in the Parkinson's disease psychosis market supporting revenue growth for the remainder of the year as we anticipate continued improvements in the conditions related to the pandemic," said Steve Davis, Chief Executive Officer. "Furthermore, we look forward to a Type A meeting with the FDA to discuss an approval path for pimavanserin in dementia-related psychosis and we continue…

    - 1Q21 net sales of $106.6 million, an 18% increase over 1Q20

    - Reiterating FY21 net sales guidance of $510 to $550 million

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the first quarter ended March 31, 2021.

    "NUPLAZID delivered strong year-over-year performance in the first quarter of 2021. Looking ahead, we see positive signs in the Parkinson's disease psychosis market supporting revenue growth for the remainder of the year as we anticipate continued improvements in the conditions related to the pandemic," said Steve Davis, Chief Executive Officer. "Furthermore, we look forward to a Type A meeting with the FDA to discuss an approval path for pimavanserin in dementia-related psychosis and we continue to advance our two Phase 3 programs for Rett syndrome and the negative symptoms of schizophrenia, as well as our Phase 2 pain program and earlier pipeline opportunities."

    Company Updates

    • The Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The Company plans to conduct a Type A meeting with the FDA to discuss the CRL and potential next steps to support an approval.
    • Top-line results from the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome are expected in the fourth quarter of 2021.
    • A Phase 2 study was initiated evaluating ACP-044, a novel, first-in-class, orally administered, non-opioid analgesic for the treatment of postoperative pain following bunionectomy surgery in March 2021.
    • A Phase 2 study evaluating ACP-044 for the treatment of pain associated with osteoarthritis is expected to commence in the second quarter of 2021.

    Financial Results

    Revenue

    Net sales of NUPLAZID (pimavanserin) were $106.6 million for the three months ended March 31, 2021, an increase of 18% as compared to $90.1 million reported for the three months ended March 31, 2020.

    Research and Development

    Research and development expenses for the three months ended March 31, 2021 were $57.0 million, compared to $72.6 million for the same period of 2020. This decrease was primarily due to the $10.0 million upfront payment to Vanderbilt University for the M1 PAM program incurred during the three months ended March 31, 2020 and decreased development costs associated with pimavanserin for major depressive disorder.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended March 31, 2021 were $111.7 million, compared to $102.0 million for the same period of 2020. This increase was primarily due to increased costs associated with preparations for the potential DRP launch, partially offset by a decrease in stock-based compensation expense.

    Net Loss

    For the three months ended March 31, 2021, Acadia reported a net loss of $66.4 million, or $0.42 per common share, compared to a net loss of $88.0 million, or $0.57 per common share, for the same period in 2020. The net losses for the three months ended March 31, 2021 and 2020 included $13.2 million and $22.3 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At March 31, 2021, Acadia's cash, cash equivalents, and investment securities totaled $577.8 million, compared to $632.0 million at December 31, 2020.

    2021 Financial Guidance

    • Acadia is reiterating its NUPLAZID net sales guidance of $510 to $550 million.
    • GAAP R&D guidance is decreased to $280 to $300 million from the previous range of $300 to $320 million. Current R&D guidance includes approximately $25 million of stock-based compensation expense.
    • GAAP SG&A guidance is decreased to $385 to $415 million from the previous range of $560 to $590 million. Previous guidance included additional investments associated with the potential DRP launch in 2021 and updated guidance reflects a reduction in these expenses. Current SG&A guidance includes approximately $50 million of stock-based compensation expense.

    Conference Call and Webcast Information

    Acadia management will review its first quarter financial results and operations via conference call and webcast today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4568937). A telephone replay of the conference call may be accessed through May 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4568937). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com, under the investors section and will be archived there until June 2, 2021.

    About NUPLAZID® (pimavanserin)

    NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not approved for any other neuropsychiatric disorders. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

    About Trofinetide

    Trofinetide is an investigational drug. It is a novel synthetic analog of the amino‐terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells – neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    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 opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinson's disease psychosis only and certain expense line items. 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 uncertainty of future commercial sales and related items that would impact net sales during 2021, 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, 2020 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.

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

    Three Months Ended March 31,

     

     

     

    2021

     

     

    2020

     

    Revenues

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    106,554

     

     

    $

    90,068

     

    Total revenues

     

     

    106,554

     

     

     

    90,068

     

    Operating expenses

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties (1)

     

     

    4,692

     

     

     

    4,974

     

    Research and development (1)

     

     

    56,973

     

     

     

    72,636

     

    Selling, general and administrative (1)

     

     

    111,661

     

     

     

    101,973

     

    Total operating expenses

     

     

    173,326

     

     

     

    179,583

     

    Loss from operations

     

     

    (66,772

    )

     

     

    (89,515

    )

    Interest income, net

     

     

    200

     

     

     

    2,989

     

    Other income (expense)

     

     

    145

     

     

     

    (1,497

    )

    Loss before income taxes

     

     

    (66,427

    )

     

     

    (88,023

    )

    Income tax expense

     

     

    21

     

     

     

     

    Net loss

     

    $

    (66,448

    )

     

    $

    (88,023

    )

    Net loss per common share, basic and diluted

     

    $

    (0.42

    )

     

    $

    (0.57

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    160,011

     

     

     

    155,368

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    163

     

     

    $

    849

     

    Research and development

     

    $

    4,830

     

     

    $

    8,457

     

    Selling, general and administrative

     

    $

    8,191

     

     

    $

    13,042

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

    March 31,

    2021

     

     

    December 31,

    2020

     

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

    577,768

     

     

    $

    631,958

     

    Accounts receivable, net

     

     

    56,832

     

     

     

    48,247

     

    Interest and other receivables

     

     

    558

     

     

     

    2,035

     

    Inventory

     

     

    10,311

     

     

     

    9,682

     

    Prepaid expenses

     

     

    28,515

     

     

     

    25,694

     

    Total current assets

     

     

    673,984

     

     

     

    717,616

     

    Property and equipment, net

     

     

    9,757

     

     

     

    9,161

     

    Operating lease right-of-use assets

     

     

    63,111

     

     

     

    47,283

     

    Intangible assets, net

     

     

    738

     

     

     

    1,108

     

    Restricted cash

     

     

    5,770

     

     

     

    5,770

     

    Other assets

     

     

    1,813

     

     

     

    1,678

     

    Total assets

     

    $

    755,173

     

     

    $

    782,616

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    8,849

     

     

    $

    8,493

     

    Accrued liabilities

     

     

    100,524

     

     

     

    97,474

     

    Total current liabilities

     

     

    109,373

     

     

     

    105,967

     

    Operating lease liabilities

     

     

    60,581

     

     

     

    44,460

     

    Other long-term liabilities

     

     

    3,613

     

     

     

    5,180

     

    Total liabilities

     

     

    173,567

     

     

     

    155,607

     

    Total stockholders' equity

     

     

    581,606

     

     

     

    627,009

     

    Total liabilities and stockholders' equity

     

    $

    755,173

     

     

    $

    782,616

     

     

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  2. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    BofA Securities 2021 Health Care Conference
    Fireside Chat Presentation: Wednesday, May 12, 2021 at 2:45 p.m. Eastern Time

    RBC Capital Markets Global Healthcare Conference
    Fireside Chat Presentation: Tuesday, May 18, 2021 at 3:05 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations 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 for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    BofA Securities 2021 Health Care Conference

    Fireside Chat Presentation: Wednesday, May 12, 2021 at 2:45 p.m. Eastern Time

    RBC Capital Markets Global Healthcare Conference

    Fireside Chat Presentation: Tuesday, May 18, 2021 at 3:05 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations 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 for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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  3. Company to host conference call and webcast on Wednesday, May 5, 2021, at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report first quarter 2021 financial results on Wednesday, May 5, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on May 5, 2021, at 5:00 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4568937). A telephone replay of the conference call may be accessed through May 19, 2021 by dialing 855-859-2056 for callers in the United…

    Company to host conference call and webcast on Wednesday, May 5, 2021, at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report first quarter 2021 financial results on Wednesday, May 5, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on May 5, 2021, at 5:00 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4568937). A telephone replay of the conference call may be accessed through May 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4568937). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until June 2, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    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. 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, 2020 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. - Conference call and webcast to be held today at 8:00 a.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.

    Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design targeting a broad DRP patient population analyzed…

    - Conference call and webcast to be held today at 8:00 a.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form.

    Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase 3 HARMONY study design targeting a broad DRP patient population analyzed as a single group, the Division, in the CRL, cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval.

    The DRP pivotal HARMONY study met its prespecified primary and secondary endpoints with robust and persuasive clinical and statistical superiority of pimavanserin over placebo, which was a prospectively agreed prerequisite for the DRP indication. Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements.

    "Acadia stands behind the robustly positive results from the pivotal Phase 3 HARMONY study and the prospectively agreed trial design and criteria for establishing efficacy in DRP. Over the entire course of the review, the Division did not raise any concerns regarding the agreed upon study design, including the issues raised in the CRL," said Steve Davis, Chief Executive Officer of Acadia. "We will immediately request a Type A meeting to work with the FDA to address the CRL and determine an expeditious path forward for the approval of pimavanserin in DRP."

    The Division also stated in the CRL that it considers the Phase 2 Alzheimer's disease psychosis study -019, a supportive study in the sNDA filing, to not be adequate and well controlled, citing that it was a single center study with no type I error control of secondary endpoints in which certain protocol deviations occurred. The Company believes these observations impact neither the positive results on the study's primary endpoint, nor the study's overall conclusions of efficacy.

    There were no safety issues or concerns raised in the CRL.

    sNDA Submission for Dementia-Related Psychosis

    The sNDA submission of pimavanserin for the treatment of hallucinations and delusions associated with DRP was 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). Pimavanserin also met the key secondary endpoint in the study, significantly reducing the risk of discontinuation for any reason by 2.2 fold compared to placebo (hazard ratio = 0.452, one-sided p=0.0024). The sNDA also included 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. In addition, the sNDA included a large safety database from completed and ongoing studies representing over 1,500 patients with neurodegenerative disease.

    Conference Call and Webcast Information

    Acadia management will discuss today's announcement via conference call and webcast at 8:00 a.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 6894834). A telephone replay of the conference call may be accessed through April 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6894834). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through May 3, 2021.

    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. 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 delusions. These symptoms may be frequent and severe and may recur over time. 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. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. 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 mortality.

    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 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®. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    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. 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, 2020 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.

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  5. - Conference call and webcast to be held today at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company's supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA…

    - Conference call and webcast to be held today at 5:00 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the Company received a notification from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company's supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.

    The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them. In July 2020, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2021 for completion of its review of the sNDA.

    Conference Call and Webcast Information

    Acadia management will discuss today's announcement via conference call and webcast at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4153316). A telephone replay of the conference call may be accessed through March 15, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4153316). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there through April 8, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    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. 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, 2020 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.

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