ACAD ACADIA Pharmaceuticals Inc.

18.45
+0.4  (+2%)
Previous Close 18.05
Open 18.1
52 Week Low 15.6792
52 Week High 57.46
Market Cap $2,963,868,590
Shares 160,643,284
Float 99,144,481
Enterprise Value $2,398,103,246
Volume 761,697
Av. Daily Volume 1,244,474
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ACP-044
Postoperative pain following bunionectomy surgery
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Trofinetide (LAVENDER)
Rett Syndrome
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
ACP-044
Pain associated with osteoarthritis
Phase 2
Phase 2
Phase 2 trial initiated 2Q 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. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming investor conferences:

    Citi's 16th Annual BioPharma Virtual Conference
    Fireside Chat Presentation: Friday, September 10, 2021 at 11:35 a.m. Eastern Time

    Morgan Stanley Virtual 19th Annual Global Healthcare Conference
    Fireside Chat Presentation: Monday, September 13, 2021 at 11:45 a.m. Eastern Time

    2021 Cantor Virtual Global Healthcare Conference
    Fireside Chat Presentation: Monday, September 27, 2021 at 1:20 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…

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

    Citi's 16th Annual BioPharma Virtual Conference

    Fireside Chat Presentation: Friday, September 10, 2021 at 11:35 a.m. Eastern Time

    Morgan Stanley Virtual 19th Annual Global Healthcare Conference

    Fireside Chat Presentation: Monday, September 13, 2021 at 11:45 a.m. Eastern Time

    2021 Cantor Virtual Global Healthcare Conference

    Fireside Chat Presentation: Monday, September 27, 2021 at 1:20 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 and Twitter.

    View Full Article Hide Full Article
  2. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Elena Ridloff, Executive Vice President and Chief Financial Officer (CFO), will be leaving the company effective September 10, 2021 to join another biopharmaceutical company. Mark Schneyer, Senior Vice President, Business Development and Chief Business Officer, will serve as Acadia's interim Chief Financial Officer. The company is conducting a formal search for a new CFO.

    "On behalf of all of us at Acadia, I want to thank Elena for her leadership and contributions which played an important role in supporting Acadia's growth and long-term business strategy, and we wish her well in her future endeavors," said Steve Davis, Chief Executive Officer.

    "I want to thank my colleagues at…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that Elena Ridloff, Executive Vice President and Chief Financial Officer (CFO), will be leaving the company effective September 10, 2021 to join another biopharmaceutical company. Mark Schneyer, Senior Vice President, Business Development and Chief Business Officer, will serve as Acadia's interim Chief Financial Officer. The company is conducting a formal search for a new CFO.

    "On behalf of all of us at Acadia, I want to thank Elena for her leadership and contributions which played an important role in supporting Acadia's growth and long-term business strategy, and we wish her well in her future endeavors," said Steve Davis, Chief Executive Officer.

    "I want to thank my colleagues at Acadia for their partnership in driving growth of the pimavanserin franchise and advancing important therapies in our pipeline," said Ms. Ridloff. "I'm confident the experienced Acadia team will continue to deliver on its mission for patients."

    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 and Twitter.

    View Full Article Hide Full Article
  3. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12, 2021, at 3:00 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 September 12, 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…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at the Canaccord Genuity 41st Annual Growth Conference on Thursday, August 12, 2021, at 3:00 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 September 12, 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 and Twitter.

    View Full Article Hide Full Article
  4. - 2Q21 net sales of $115.2 million, a 5% increase over 2Q20

    - Fiscal year 2021 revenue guidance reduced to $480 to $515 million

    - Type A meeting held with FDA regarding DRP; Acadia will continue discussion with FDA in another meeting later this year

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the second quarter ended June 30, 2021.

    "NUPLAZID performed well in the second quarter of 2021, highlighted by our ability to drive growth while still navigating the continued impact from the pandemic," said Steve Davis, Chief Executive Officer. "We recently completed a Type A meeting with the FDA regarding pimavanserin for dementia-related psychosis and plan to continue our engagement in another meeting with…

    - 2Q21 net sales of $115.2 million, a 5% increase over 2Q20

    - Fiscal year 2021 revenue guidance reduced to $480 to $515 million

    - Type A meeting held with FDA regarding DRP; Acadia will continue discussion with FDA in another meeting later this year

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD), today announced its financial results for the second quarter ended June 30, 2021.

    "NUPLAZID performed well in the second quarter of 2021, highlighted by our ability to drive growth while still navigating the continued impact from the pandemic," said Steve Davis, Chief Executive Officer. "We recently completed a Type A meeting with the FDA regarding pimavanserin for dementia-related psychosis and plan to continue our engagement in another meeting with the FDA later this year to further discuss potential paths to approval. Looking ahead, we plan to announce top-line results by the end of the year from our Phase 3 study in Rett syndrome and our proof-of-concept Phase 2 study in postoperative pain."

    Company Updates

    • Completed a Type A End of Review meeting regarding the FDA's complete response letter (CRL) for the sNDA for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). At the meeting, the FDA reiterated their stated position in the CRL, that pimavanserin should be studied by individual subgroups of dementia, and advised that the best path forward is to conduct an additional clinical study in each of the subgroups for which we seek approval. However, the FDA also indicated that they are open to having another meeting to discuss additional analyses from the HARMONY and -019 studies in support of a potential resubmission without an additional clinical study.
    • The New England Journal of Medicine published the positive results from the Phase 3 HARMONY study evaluating pimavanserin in patients with dementia-related psychosis in July 2021.
    • Results from an open-label extension safety study with pimavanserin supporting sustained response in Parkinson's disease psychosis patients was published online in the June 2021 issue of Parkinsonism and Related Disorders.
    • Completed enrollment of the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome, with top-line results expected in the fourth quarter of 2021.
    • Initiated a Phase 2 study of ACP-044 for pain associated with osteoarthritis in the second quarter of 2021.
    • Top-line results from the Phase 2 study of ACP-044 for the treatment of postoperative pain following bunionectomy surgery are expected in the fourth quarter of 2021.

    Financial Results

    Revenue

    Net sales of NUPLAZID® (pimavanserin) were $115.2 million for the three months ended June 30, 2021, an increase of 5% as compared to $110.1 million reported for the three months ended June 30, 2020. For the six months ended June 30, 2021 and 2020, Acadia reported net product sales of $221.8 million and $200.2 million, respectively.

    Research and Development

    Research and development expenses for the three months ended June 30, 2021 were $56.9 million, compared to $64.3 million for the same period of 2020. The decrease in the three month period ending June 2021 compared to June 2020 was largely due to the cessation of development costs of pimavanserin for major depressive disorder and lower development costs for DRP. For the six months ended June 30, 2021 and 2020, research and development expenses were $113.9 million and $136.9 million. The decrease for the six month period ending June 2021 compared to June 2020 was largely due to lower development costs of pimavanserin and trofinetide, partially offset by increased development costs for ACP-044.

    Selling, General and Administrative

    Selling, general and administrative expenses for the three months ended June 30, 2021 were $96.8 million, compared to $84.3 million for the same period of 2020. The increase for the three month period ending June 2021 compared to June 2020 was primarily due to increased costs associated with advertising and promotion, corporate support functions and stock-based compensation. For the six months ended June 30, 2021 and 2020, selling, general and administrative expenses were $208.5 million and $186.3 million, respectively. The increase for the six month period ending June 2021 compared to June 2020 was primarily due to increased costs associated with advertising, promotion and preparations for the potential DRP launch.

    Net Loss

    For the three months ended June 30, 2021, Acadia reported a net loss of $43.9 million, or $0.27 per common share, compared to a net loss of $42.1 million, or $0.27 per common share, for the same period in 2020. The net losses for the three months ended June 30, 2021 and 2020 included $22.0 million and $19.5 million, respectively, of non-cash stock-based compensation expense. For the six months ended June 30, 2021, Acadia reported a net loss of $110.3 million, or $0.69 per common share, compared to a net loss of $130.2 million, or $0.83 per common share, for the same period in 2020. The net losses for the six months ended June 30, 2021 and 2020 included $35.2 million and $41.9 million, respectively, of non-cash stock-based compensation expense.

    Cash and Investments

    At June 30, 2021, Acadia's cash, cash equivalents, and investment securities totaled $556.9 million, compared to $632.0 million at December 31, 2020.

    2021 Financial Guidance

    • NUPLAZID net sales guidance is decreased to $480 to $515 million from the previous range of $510 to $550 million as a result of the continued impact of the pandemic with fewer Parkinson's disease patient office visits and lower occupancy rates at long-term care facilities, as well as a revised gross-to-net expectation of approximately 20% compared to prior expectation of high teens.
    • GAAP R&D is decreased to $250 to $270 million from the previous range of $280 to $300 million. Current R&D guidance includes approximately $25 million of stock-based compensation expense.
    • GAAP SG&A guidance is reiterated at $385 to $415 million. Current SG&A guidance includes approximately $50 million of stock-based compensation expense.

    Conference Call and Webcast Information

    Acadia management will review its second quarter financial results and operations via conference call and webcast today at 4:30 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 8065926). A telephone replay of the conference call may be accessed through August 18, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 8065926). 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 September 1, 2021.

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

    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 and Twitter.

    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 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 June 30,

     

     

    Six Months Ended June 30,

     

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Revenues

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Product sales, net

     

    $

    115,221

     

     

    $

    110,103

     

     

    $

    221,775

     

     

    $

    200,171

     

    Total revenues

     

     

    115,221

     

     

     

    110,103

     

     

     

    221,775

     

     

     

    200,171

     

    Operating expenses

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

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

     

     

    5,206

     

     

     

    5,474

     

     

     

    9,898

     

     

     

    10,448

     

    Research and development (1)

     

     

    56,935

     

     

     

    64,295

     

     

     

    113,908

     

     

     

    136,931

     

    Selling, general and administrative (1)

     

     

    96,789

     

     

     

    84,344

     

     

     

    208,450

     

     

     

    186,317

     

    Total operating expenses

     

     

    158,930

     

     

     

    154,113

     

     

     

    332,256

     

     

     

    333,696

     

    Loss from operations

     

     

    (43,709

    )

     

     

    (44,010

    )

     

     

    (110,481

    )

     

     

    (133,525

    )

    Interest income, net

     

     

    133

     

     

     

    1,825

     

     

     

    333

     

     

     

    4,814

     

    Other income (expense)

     

     

    178

     

     

     

    437

     

     

     

    323

     

     

     

    (1,060

    )

    Loss before income taxes

     

     

    (43,398

    )

     

     

    (41,748

    )

     

     

    (109,825

    )

     

     

    (129,771

    )

    Income tax expense

     

     

    473

     

     

     

    393

     

     

     

    494

     

     

     

    393

     

    Net loss

     

    $

    (43,871

    )

     

    $

    (42,141

    )

     

    $

    (110,319

    )

     

    $

    (130,164

    )

    Net loss per common share, basic and diluted

     

    $

    (0.27

    )

     

    $

    (0.27

    )

     

    $

    (0.69

    )

     

    $

    (0.83

    )

    Weighted average common shares outstanding, basic and diluted

     

     

    160,421

     

     

     

    156,535

     

     

     

    160,217

     

     

     

    155,951

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    (1) Includes the following stock-based compensation expense

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of product sales, license fees and royalties

     

    $

    423

     

     

    $

    743

     

     

    $

    586

     

     

    $

    1,592

     

    Research and development

     

    $

    7,319

     

     

    $

    7,235

     

     

    $

    12,149

     

     

    $

    15,692

     

    Selling, general and administrative

     

    $

    14,263

     

     

    $

    11,529

     

     

    $

    22,454

     

     

    $

    24,571

     

     

    ACADIA PHARMACEUTICALS INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

    June 30,

    2021

     

     

    December 31,

    2020

     

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and investment securities

     

    $

    556,918

     

     

    $

    631,958

     

    Accounts receivable, net

     

     

    51,367

     

     

     

    48,247

     

    Interest and other receivables

     

     

    453

     

     

     

    2,035

     

    Inventory

     

     

    10,786

     

     

     

    9,682

     

    Prepaid expenses

     

     

    26,206

     

     

     

    25,694

     

    Total current assets

     

     

    645,730

     

     

     

    717,616

     

    Property and equipment, net

     

     

    9,197

     

     

     

    9,161

     

    Operating lease right-of-use assets

     

     

    61,371

     

     

     

    47,283

     

    Intangible assets, net

     

     

    369

     

     

     

    1,108

     

    Restricted cash

     

     

    5,770

     

     

     

    5,770

     

    Other assets

     

     

    1,992

     

     

     

    1,678

     

    Total assets

     

    $

    724,429

     

     

    $

    782,616

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    9,065

     

     

    $

    8,493

     

    Accrued liabilities

     

     

    86,263

     

     

     

    97,474

     

    Total current liabilities

     

     

    95,328

     

     

     

    105,967

     

    Operating lease liabilities

     

     

    59,134

     

     

     

    44,460

     

    Other long-term liabilities

     

     

    5,129

     

     

     

    5,180

     

    Total liabilities

     

     

    159,591

     

     

     

    155,607

     

    Total stockholders' equity

     

     

    564,838

     

     

     

    627,009

     

    Total liabilities and stockholders' equity

     

    $

    724,429

     

     

    $

    782,616

     

     

    View Full Article Hide Full Article
  5. - Pimavanserin met the primary endpoint of reduced risk of relapse of psychosis by 2.8 fold compared to placebo

    - Pimavanserin met the secondary endpoint of significantly reducing trial discontinuation for any reason by 2.2 fold

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the New England Journal of Medicine published results from the Phase 3 HARMONY study, an international, double-blind, placebo-controlled relapse prevention trial in 392 patients evaluating pimavanserin as an investigational treatment in patients with hallucinations and delusions associated with dementia-related psychosis (DRP). The study included patients across five subgroups of dementia: Alzheimer's disease, dementia with Lewy bodies, frontotemporal…

    - Pimavanserin met the primary endpoint of reduced risk of relapse of psychosis by 2.8 fold compared to placebo

    - Pimavanserin met the secondary endpoint of significantly reducing trial discontinuation for any reason by 2.2 fold

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the New England Journal of Medicine published results from the Phase 3 HARMONY study, an international, double-blind, placebo-controlled relapse prevention trial in 392 patients evaluating pimavanserin as an investigational treatment in patients with hallucinations and delusions associated with dementia-related psychosis (DRP). The study included patients across five subgroups of dementia: Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease dementia, and vascular dementia.

    The HARMONY study was stopped early due to positive efficacy at the pre-planned interim analysis upon recommendation of the trial's independent data safety monitoring board. HARMONY met its primary endpoint by significantly reducing the risk of relapse of psychosis by 2.8 fold compared to placebo in the double-blind period (hazard ratio (HR)=0.35, two-sided p=0.005; one-sided p=0.0023). The study also met its secondary endpoint by significantly reducing the time to trial discontinuation for any reason (HR=0.45, two-sided p=0.005; one-sided p=0.0024). The data from the HARMONY study demonstrates that patients with DRP who had responded to pimavanserin had a significantly lower risk of relapse of psychosis with continuation of pimavanserin compared to placebo up to 26 weeks.

    "The relapse prevention design of the HARMONY study mirrors exactly what we do in clinical practice. This landmark trial showed that when patients responded to pimavanserin and then continued treatment, they were almost three times less likely to develop recurrence of their hallucinations and delusions than those patients who discontinued pimavanserin treatment," said the study's lead author, Dr. Pierre N. Tariot, Banner Alzheimer's Institute director. "This is a substantial finding and a significant advance for a critical public health need in our field. There is no FDA approved treatment for DRP, and the majority of antipsychotics currently used off-label have equivocal efficacy and may accelerate cognitive decline."

    Pimavanserin was well-tolerated over the nine-month study duration. In a pre-specified analysis, pimavanserin was not associated with a decline in cognition as measured by Mini-Mental State Examination (MMSE) or the onset or worsening of motor symptoms as measured by Extrapyramidal Symptom Rating Scale A (ESRS-A).

    "The HARMONY study findings demonstrated three important results. First, in the 12-week open-label period, pimavanserin treatment showed a sustained reduction of psychotic symptoms. Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of psychosis relapse compared to patients on placebo. Third, pimavanserin was well-tolerated by elderly patients with DRP," said Steve Davis, Chief Executive Officer of Acadia. "We are very pleased that the New England Journal of Medicine has chosen to publish the important results of this study."

    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. The study included patients with Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease dementia, and vascular dementia. A total of 392 patients were enrolled in the study, with a mean age of 74.5 years and a mean MMSE score of 16.7. The primary endpoint in the study was time from randomization to relapse of psychosis in the double-blind period as represented by the Kaplan-Meier curve and the hazard ratio.

    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 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 sustained treatment response were then randomized into the double-blind period of the study to continue their pimavanserin dose 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 (HR=0.35, p=0.005).

    In the double-blind period, similar, low rates of adverse events were observed, 43 (41.0%) patients on pimavanserin (n=105) and 41 (36.6%) patients on placebo (n=112). 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 that 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.1 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, which may include 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.2,3 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.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 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 and Twitter.

    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.

    References

    1Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

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

    32017 Alzheimer's Disease Facts and Figures and Acadia market research.

    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).

    View Full Article Hide Full Article
View All ACADIA Pharmaceuticals Inc. News