Acadia History

FDA Approves DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adults and Pediatric Patients Two Years of Age and Older.

Acadia and Stoke Therapeutics collaborate to pursue multiple RNA-based treatments for severe and rare genetic neurodevelopmental diseases. 

Acadia resubmitted supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin), narrowing the proposed indication from dementia-related psychosis to Alzheimer’s disease psychosis. FDA has assigned a Target action date of August 4, 2022, and the FDA’s Division of Psychiatry is planning to hold an Advisory committee meeting on June 17 in connection with its review.^‡

New England Journal of Medicine publishes results from the Phase 3 HARMONY study evaluating pimavanserin in patients with dementia-related psychosis.^‡

Acadia reports positive top-line results from the Phase 3 Lavender™ study evaluating trofinetide, an investigational drug for the treatment of Rett syndrome.*

Acadia acquires CerSci Therapeutics, adding novel pain program to portfolio.

Acadia and Neuren Pharmaceuticals announce rare pediatric disease designation for trofinetide for the treatment of Rett syndrome.*

Acadia and Vanderbilt University announce an exclusive license agreement and research collaboration to develop and commercialize novel drug candidates targeting the muscarinic M1 receptor with the potential to treat a range of central nervous system disorders.

Acadia submits a Supplemental New Drug Application to the U.S. FDA for NUPLAZID® (pimavanserin), for the treatment of hallucinations and delusions associated with dementia-related psychosis.^‡ FDA accepts our application.

Acadia initiates Phase 3 CLARITY program with pimavanserin as adjunctive treatment for major depressive disorder.^‡

Acadia presents positive top-line results from pivotal Phase 3 HARMONY trial of pimavanserin in patients with dementia-related psychosis^‡ at 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting.

Acadia announces positive top-line results from Phase 2 ADVANCE trial of pimavanserin as treatment for negative symptoms of schizophrenia.^‡

Acadia initiates Phase 3 pivotal study of trofinetide in Rett syndrome*, a rare neurodevelopment CNS disorder.

Acadia reports positive top-line results from Phase 2 CLARITY trial of pimavanserin as adjunctive treatment for major depressive disorder.^‡

Acadia signs exclusive North American license agreement for the development and commercialization of trofinetide for Rett syndrome.*

FDA approves new dosing formulation and strength for NUPLAZID^® (pimavanserin).

Phase 2 study evaluating pimavanserin in patients Alzheimer’s disease psychosis published in The Lancet Neurology.^‡

Acadia is named one of Forbes’ “Most Innovative Growth Companies” (#11 of 100).

FDA Approves NUPLAZID^® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis.

Acadia reports positive Phase 2 data for pimavanserin in patients with Alzheimer’s disease psychosis.^‡

Acadia initiates ENHANCE Phase 3 trial with pimavanserin as adjunctive treatment for schizophrenia with inadequate response to current antipsychotic treatment.^‡

Acadia initiates ADVANCE Phase 2 trial with pimavanserin as adjunctive treatment for negative symptoms of schizophrenia.^‡

Acadia is added to Large-Cap Russell 1000 Index.

New Drug Application (NDA) for NUPLAZID^® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis Accepted and Granted Priority Review by the FDA.

Steve Davis is appointed as President and Chief Executive Officer.

Acadia receives FDA Breakthrough Therapy Designation for NUPLAZID^® (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Acadia announces publication in The Lancet of pivotal Phase 3 Parkinson’s disease psychosis trial with pimavanserin.

Acadia is added to the NASDAQ Biotechnology and the Russell 2000 indices.

Acadia meets with the FDA, then announces an expedited path to a New Drug Application filing with pimavanserin for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Acadia announces presentation of data from Phase 3 trial with pimavanserin for Parkinson’s disease psychosis at the American Academy of Neurology Annual Meeting.

Acadia reports positive Phase 3 data for pimavanserin in patients with Parkinson’s disease psychosis.

Acadia initiates a pivotal Phase 3 efficacy, tolerability and safety study with pimavanserin in patients with Parkinson’s disease psychosis.

Acadia regains full worldwide rights to pimavanserin following the conclusion of its collaboration with Biovail.

Acadia forms collaboration with Biovail to develop and commercialize pimavanserin in North America.

Acadia reports positive Phase 2 data for pimavanserin as a co-therapy for patients with schizophrenia.^‡

Acadia reports positive Phase 2 data for pimavanserin in patients with Parkinson’s disease psychosis.

Acadia completes its initial public offering and trades under the symbol “ACAD” on the NASDAQ Stock Market.

Pimavanserin first synthesized.

Pimavanserin is first synthesized by an Acadia chemist working in Acadia’s Copenhagen facility. 

Our scientists start a project to discover new non-dopaminergic antipsychotic agents selectively acting as inverse agonists on the 5-HT2A receptor.

Company name changed to Acadia Pharmaceuticals Inc.

Inspired by the power and beauty of Acadia National Park, the company rebrands.

We shift our focus to developing our own portfolio of product candidates.

Our headquarters moves from Winooski, Vermont, to the biotech hub of San Diego, California

Our medicinal chemistry operations are established in Copenhagen, Denmark—supported by Danish investors.

Acadia establishes its first of several drug discovery and development collaborations with Allergan.

Company founded.

Receptor Technologies is founded by Mark Brann, Ph.D., a professor at the University of Vermont.

The company starts by working with major pharmaceutical companies to perform high-throughput screening based on its proprietary functional genomics platform, R-SAT.

Important Disclosures

*The safety and efficacy of the investigational agent(s) listed above have not been established or approved by the U.S. Food and Drug Administration (FDA). 
^‡The safety and efficacy of the investigational use of NUPLAZID® (pimavanserin) have not been established or approved by the FDA. For NUPLAZID’s FDA-approved indication, please read the full Prescribing Information, including Boxed WARNING.