ACAD ACADIA Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
Pimavanserin - Harmony
Alzheimer’s disease psychosis
|
PDUFA
PDUFA
|
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
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 to be initiated 1H 2021.
|
|
Pimavanserin - Advance-2
Adjunctive treatment in patients with negative symptoms of schizophrenia
|
Phase 3
Phase 3
|
Phase 3 trial initiated 3Q 2020.
|
|
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.
|
|
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
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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following upcoming virtual investor conferences:
Citi 15th Annual BioPharma Virtual Conference
Date: Wednesday, September 9, 2020
Panel: Emerging Therapies for Psychiatric Disorders at 1:30 p.m. Eastern TimeMorgan Stanley 18th Annual Global Healthcare Conference
Date: Monday, September 14, 2020
Fireside chat presentation: 3:45 p.m. Eastern TimeCantor Virtual Global Healthcare Conference
Date: Wednesday, September 16, 2020
Fireside chat presentation: 11:20 a.m. Eastern TimeThese conferences will all be held virtually. Live webcasts of the panel and 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 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's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.View source version on businesswire.com: https://www.businesswire.com/news/home/20200902005382/en/
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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the appointment of Dr. Gudarz Davar as Executive Vice President and Head of Research and Development. Dr. Davar will be responsible for leading research and development activities at ACADIA and will serve as a member of the company's Executive Management Committee. In this role, he will report to Serge Stankovic, M.D., M.S.P.H., President of ACADIA. Dr. Stankovic will continue to oversee research and development, regulatory, medical affairs, external innovation and pharmacovigilance functions for the company.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200831005180/en/
Gudarz Davar, M.D., Executive Vice President and Head of Research and Development (Photo: Business Wire)
"We are thrilled to welcome Gudarz to ACADIA's executive team as a senior neurologist and neuroscientist with strong scientific, academic and corporate leadership experience," said Steve Davis, ACADIA's Chief Executive Officer. "As we prepare for the potential approval and launch in the U.S. of our second indication for pimavanserin, the treatment of hallucinations and delusions associated with dementia-related psychosis, we continue to focus on developing innovative new treatments to address unmet needs. Gudarz will be a valuable addition to our executive team as we execute and grow our pipeline to drive long-term growth."
"I share ACADIA's passion for improving the lives of patients with central nervous system disorders and am particularly excited to use my experience to strengthen the breadth and depth of ACADIA's pipeline," said Dr. Davar.
Dr. Davar joins ACADIA from Eli Lilly where he was Vice President, Head of Global Neurology Clinical Development, the senior leadership role responsible for the global development of all neuroscience and core Lilly biomedicines assets through clinical testing and life of the product. Under his leadership were the recent global approvals of Emgality® for migraine prevention and U.S. approval for the treatment of cluster headache, as well as the U.S. approval of REYVOW® as a first-in-class, novel, acute treatment for migraine.
Prior to Eli Lilly, he served in senior leadership roles in neurology and clinical development at Allergan, Biogen Idec and Amgen. At Allergan, he led a global research and development and commercialization partnership focused on cognitive impairment and neurobehavioral symptoms in Alzheimer's disease.
Dr. Davar received his medical degree from Dalhousie University in Halifax, Nova Scotia. He completed residency at University of Michigan Hospitals, Ann Arbor, Michigan and is board certified in Neurology.
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's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. 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. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200831005180/en/
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- First-in-class, non-opioid, mechanism interrupts pain pathways
- Phase 2 initiation planned for the first half of 2021
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced the acquisition of CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. The lead development program is a unique Reactive Species Decomposition Accelerant (RSDAx), a first-in-class mechanism focused on interrupting pathways that sensitize neurons to pain. The portfolio contains additional preclinical stage molecules, including brain penetrant molecules, with potential for symptomatic and disease modifying treatment utility in neurodegenerative diseases.
This acquisition strengthens ACADIA's clinical pipeline to include non-opioid pain therapies that have potential non-addictive properties and reduced side effects typically seen with current opioid treatments. The lead molecule, ACP-044, has shown promising efficacy and safety results in animal models evaluating incisional, inflammatory, and neuropathic pain, as well as favorable tolerability and pharmacokinetic properties in Phase 1 trials. The novel RSDAx mechanism of action is thought to interfere with multiple pain pathways treating pain simultaneously. ACADIA plans to initiate a Phase 2 clinical study in the first half of 2021.
"There is an urgent need for new approaches to treat pain without causing addiction," said Steve Davis, ACADIA's Chief Executive Officer. "We are excited by the potential clinical utility of this program across multiple pain modalities due to its novel non-opioid mechanism of action. By acquiring CerSci, ACADIA is further strengthening our development pipeline for long-term growth in central nervous system disorders."
"For too long, the options for patients with acute and chronic pain have been very limited," said Lucas Rodriguez, CEO and co-founder of CerSci. "I am highly confident that ACADIA, with its proven development and commercialization capabilities, can advance CerSci's program and ultimately deliver a new generation of medicines to treat acute post-operative as well as chronic pain conditions."
Under the terms of the agreement, ACADIA acquired all of the outstanding shares of CerSci for $52.5 million, primarily in ACADIA stock. The transaction closed on August 24, 2020. CerSci shareholders may also receive up to $887 million in development, commercialization, and sales milestones in addition to tiered royalties in the mid-single digits based on annual net sales.
BofA Securities is serving as financial advisor and Paul Hastings, LLP is serving as legal advisor to ACADIA. Evercore is serving as financial advisor and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor to CerSci. CerSci's major investors include JDH Investment Management, LLC, Hiawatha Education Foundation, Lennox Capital Partners, LP and West Summit Investments, LP.
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's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, ACP-044 for pain management and an early-stage muscarinic receptor program. ACADIA submitted a supplemental new drug application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis on June 3, 2020. The FDA has accepted for filing the sNDA for DRP with a PDUFA date of April 3, 2021. Pimavanserin is not approved for dementia-related psychosis. 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 discovery, development and commercialization of any compounds from the above described acquisition, the clinical potential of and therapeutic opportunity for products based on such compounds 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, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200825005405/en/
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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will present at The JMP Securities CNS Forum on Wednesday, August 19, 2020, at 11:00 a.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 19, 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's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200812005131/en/
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- 2Q20 Net Sales of $110.1 Million, a 32% Increase Over 2Q19
- FDA filed the supplemental NDA for pimavanserin for the treatment of dementia-related psychosis with a PDUFA action date set for April 3, 2021
- Initiated ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2020.
"In the first half of 2020 we drove robust growth of NUPLAZID®. With the FDA filing of our sNDA for dementia-related psychosis we are one step closer to potentially delivering the first and only approved treatment for this devastating condition," said Steve Davis, ACADIA's Chief Executive Officer. "Building upon the successful development of our PDP and DRP programs, our clinical team is focused on advancing our innovative early- and late-stage pipeline."
Company Updates
- The U.S. Food and Drug Administration (FDA) filed the supplemental NDA for pimavanserin for the treatment of the hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA has assigned a PDUFA (Prescription Drug User Fee Act) action date of April 3, 2021.
- ACADIA announced top-line results from the Phase 3 CLARITY study of pimavanserin for adjunctive treatment in patients with major depressive disorder. The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.
- ACADIA initiated its second pivotal study, ADVANCE-2, a 26-week, placebo-controlled, 386 patient Phase 3 study designed to evaluate the efficacy and safety of the 34 mg dose of pimavanserin for the treatment of the negative symptoms of schizophrenia.
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ACADIA presented important clinical data at recent virtual medical congresses:
- In May, at the 2020 American Society of Clinical Psychopharmacology virtual annual meeting, ACADIA presented six posters and an oral presentation on the positive pivotal ADVANCE study results, titled ADVANCE: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Negative Symptoms of Schizophrenia.
- In July, at the 2020 Alzheimer's Association International Conference virtual event, ACADIA presented nine posters and an oral presentation on the positive findings from the open-label portion of the HARMONY study, titled HARMONY: Response to Pimavanserin in the 12-Week, Open-label Treatment Phase.
- ACADIA appointed Mark Schneyer as Senior Vice President, Business Development and Chief Business Officer and appointed Spyros Papapetropoulos, M.D., Ph.D., as Senior Vice President, Head of Clinical Development.
Financial Results
Revenue
Net sales of NUPLAZID (pimavanserin) were $110.1 million for the three months ended June 30, 2020, an increase of 32% as compared to $83.2 million reported for the three months ended June 30, 2019. For the six months ended June 30, 2020 and 2019, ACADIA reported net product sales of $200.2 million and $146.2 million, respectively.
Research and Development
Research and development expenses for the three months ended June 30, 2020 were $64.3 million, compared to $67.3 million for the same period of 2019. The decrease in the three month period ending June 2020 compared to June 2019 was primarily due to lower development costs for pimavanserin in schizophrenia and DRP. For the six months ended June 30, 2020 and 2019, research and development expenses were $136.9 million and $120.2 million, respectively. The increase during the six month period ending June 2020 compared to June 2019 was primarily due to an upfront payment of $10.0 million to Vanderbilt University for the M1 PAM program and increased development costs associated with trofinetide, offset by decreased development costs for pimavanserin in schizophrenia and DRP.
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended June 30, 2020 were $84.3 million, compared to $68.0 million for the same period of 2019. For the six months ended June 30, 2020 and 2019, selling, general and administrative expenses were $186.3 million and $161.1 million, respectively. The increase during the 2020 periods as compared to 2019 was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.
Net Loss
For the three months ended June 30, 2020, ACADIA reported a net loss of $42.1 million, or $0.27 per common share, compared to a net loss of $54.9 million, or $0.38 per common share, for the same period in 2019. The net losses for the three months ended June 30, 2020 and 2019 included $19.5 million and $20.4 million, respectively, of non-cash stock-based compensation expense. For the six months ended June 30, 2020, ACADIA reported a net loss of $130.2 million, or $0.83 per common share, compared to a net loss of $140.2 million, or $0.97 per common share, for the same period in 2019. The net losses for the six months ended June 30, 2020 and 2019 included $41.9 million and $40.3 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At June 30, 2020, ACADIA's cash, cash equivalents, and investment securities totaled $658.6 million, compared to $697.4 million at December 31, 2019.
2020 Financial Guidance
- NUPLAZID net sales guidance is updated to $430 to $450 million from the previous range of $420 to $450 million.
- GAAP R&D guidance is decreased to $265 to $280 million from the previous range of $270 to $285 million.
- GAAP SG&A guidance is decreased to $400 to $420 million from the previous range of $425 to $445 million.
- Non-cash stock-based compensation expense guidance of $90 to $100 million is unchanged compared to prior guidance.
- 2020 year-end cash, cash equivalents, and investment securities is expected to be $570 to $590 million from a previous range of $470 to $500 million.
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 9828845). A telephone replay of the conference call may be accessed through August 19, 2020 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9828845). 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 2, 2020.
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 FDA-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 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's development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program. 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 opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; unanticipated impacts of COVID-19 on ACADIA's business, including its commercial sales operations, current and planned clinical trials, supply chain, and guidance for full-year 2020 NUPLAZID net sales 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 2020, 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.
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,
2020
2019
2020
2019
Revenues
Product sales, net
$
110,103
$
83,205
$
200,171
$
146,164
Total revenues
110,103
83,205
200,171
146,164
Operating expenses
Cost of product sales, license fees and royalties (1)
5,474
4,995
10,448
9,575
Research and development (1)
64,295
67,320
136,931
120,243
Selling, general and administrative (1)
84,344
67,981
186,317
161,071
Total operating expenses
154,113
140,296
333,696
290,889
Loss from operations
(44,010
)
(57,091
)
(133,525
)
(144,725
)
Interest income, net
1,825
2,527
4,814
5,461
Other income (expense)
437
(12
)
(1,060
)
(241
)
Loss before income taxes
(41,748
)
(54,576
)
(129,771
)
(139,505
)
Income tax expense
393
365
393
740
Net loss
$
(42,141
)
$
(54,941
)
$
(130,164
)
$
(140,245
)
Net loss per common share, basic and diluted
$
(0.27
)
$
(0.38
)
$
(0.83
)
$
(0.97
)
Weighted average common shares outstanding, basic and diluted
156,535
144,314
155,951
144,148
(1) Includes the following stock-based compensation expense
Cost of product sales, license fees and royalties
$
743
$
803
$
1,592
$
1,798
Research and development
$
7,235
$
7,901
$
15,692
$
15,781
Selling, general and administrative
$
11,529
$
11,718
$
24,571
$
22,726
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30,
2020
December 31,
2019
(unaudited)
Assets
Cash, cash equivalents and investment securities
$
658,551
$
697,429
Accounts receivable, net
43,785
35,781
Interest and other receivables
2,343
2,093
Inventory
6,210
6,341
Prepaid expenses
24,846
18,606
Total current assets
735,735
760,250
Property and equipment, net
6,687
3,180
Operating lease right-of-use assets
7,880
9,524
Intangible assets, net
1,846
2,585
Restricted cash
5,770
4,787
Other assets
1,731
2,857
Total assets
$
759,649
$
783,183
Liabilities and stockholders' equity
Accounts payable
$
6,466
$
7,222
Accrued liabilities
79,956
67,604
Total current liabilities
86,422
74,826
Operating lease liabilities
5,669
6,361
Other long-term liabilities
4,545
2,861
Total liabilities
96,636
84,048
Total stockholders' equity
663,013
699,135
Total liabilities and stockholders' equity
$
759,649
$
783,183
View source version on businesswire.com: https://www.businesswire.com/news/home/20200805005935/en/