The central nervous system controls most of the body’s functions. It transmits signals between the brain and the internal organs. When these signals go wrong due to disease, all kinds of symptoms will develop. Acadia Pharmaceuticals (Nasdaq: ACAD) develops small molecule drugs for treatment of CNS disorders. The performance of Acadia Pharmaceuticals stock strongly relates to the results of numerous clinical trials of its drugs currently underway. Most of these trials are in the early stages.

Acadia Pharmaceuticals History

In 1993, Acadia Pharmaceuticals stock was founded under the name Receptor Technologies by Dr. Mark Brann, a professor at the University of Vermont. Just four years later, the company name changed to Arcadia Pharmaceuticals Inc. and moved its headquarters to San Diego, California. In 2004, Arcadia Pharmaceuticals completed its initial public offering. It trades on the Nasdaq under the symbol ACAD.

In 2020, Acadia Pharmaceuticals acquired CerSci Therapeutics. CerSci Therapeutics is a clinical-stage biotech company with global rights to various new compounds for the treatment of neurological conditions. Significantly, this includes non-opioid therapies for the treatment of acute and chronic pain. This acquisition enhances the company’s clinical pipeline to include non-opioid pain therapies. Because of the profound need to discover therapeutic pain medication that does not lead to addiction, this could eventually develop into a new generation of drugs that treat pain without the substantial risks of opioids.

Acadia Pharmaceuticals Stock and Nuplazid®

In 2016, the FDA approved Nuplazid® for the treatment of delusions and hallucinations associated with Parkinson’s disease psychosis. The development of delusions and psychosis in patients with Parkinson’s is not uncommon. In 2018, the FDA conducted a thorough evaluation of the drug, reaffirming Nuplazid®’s benefits. Approval for this drug is only for patients with delusions or hallucinations who do not have Parkinson’s disease. As a selective serotonin inverse agonist, Nuplazid specifically blocks serotonin 5-HT2A receptor activity. Previous research links 5-HT2A receptor activity to psychosis and depression, as well as additional neuropsychiatric disorders.

However, in April 2021, the FDA rejected Acadia Pharmaceutical’s request that Nuplazid® become the first drug approved for patients with dementia suffering from delusions or hallucinations. Just nine months earlier, the FDA had agreed to review Acadia Pharmaceutical’s supplemental New Drug Application. In March 2021, the FDA announced deficiencies requiring resolution before discussion on labeling and post-marketing requirements and commitments could take place. The rejection the following month caused Acadia Pharmaceuticals stock to drop 20.8% upon the announcement.

In the Pipeline

Although Nuplazid® is the only Acadia Pharmaceuticals product approved by the FDA as of April 2022, there are several other drugs in the pipeline. Two additional supplemental NDAs for pimavanserin are in the third phase of clinical trials. Along with the dementia trials, the company has also filed a supplemental NDA for treating the negative symptoms of schizophrenia. Affecting about 1 percent of the population, negative symptoms relating to this chronic mental illness include emotional withdrawal, cognitive impairment, and loss of interest. Up to 50% of schizophrenia patients suffer from negative symptoms. To date, there is no FDA-approved drug for the treatment of negative symptoms of schizophrenia.

The other drugs in the pipeline for Acadia Pharmaceuticals stock include:

• Trofinetide: Now in its third phase of clinical trials, Trofinetide is designed to treat core symptoms of Rett’s Syndrome. This disease is a debilitating neurological disorder primarily affecting females. The condition is frequently mistaken as autism, developmental delay, or cerebral palsy in babies between the ages of six to 18 months. Infant development is initially normal until the age of six months. Symptoms include seizures, scoliosis, sleep disturbance, and abnormal breathing patterns. At this time, there are no approved medications for treating Rett’s Syndrome. Acadia Pharmaceuticals plans to submit an NDA for Trofinetide in mid-2022.
• ACP-044: Now in the earliest stages of clinical testing, ACP-044 is a novel orally-administered analgesic designed to treat postoperative and osteoarthritis pain. A Phase 2 study evaluating ACP-044 for postoperative pain treatment after bunionectomy surgery commenced in March 2021.
• ACP-319: Also in its earliest clinical testing stages, ACP-319 may provide a novel approach to improve cognitive function and other neuropsychiatric issues in patients diagnosed with central nervous system disorders.

Acadia Pharmaceuticals Stock

In 2021, Acadia Pharmaceuticals’ revenue was $484.14 million. Sales growth was 9.6%. Total assets were $700 million. As of April 27, 2022, the 52-week high was $28.05 and the 52-week low was $15.68. Additionally, the stock does not pay dividends.

Stock Considerations

The outlook for Acadia Pharmaceuticals stock depends significantly upon the FDA’s final decision regarding Nuplazid®. In February 2022, the company refiled its supplementary NDA with a smaller patient population in mind. Rather than focus on dementia per se, Acadia Pharmaceuticals seeks FDA approval for Nuplazid® for Alzheimer’s disease patients with psychosis. However, patients with Alzheimer’s make up the greatest percentage of those with dementia-related psychosis. The FDA set a decision date of August 4, 2022.