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Best Stocks of the Decade: Acadia’s Drug Development Success

San Diego biopharma’s spectacular stock gains since 2010 have been driven by its development of Nuplazid, a drug to treat Parkinson’s disease psychosis.

A promising but little-known San Diego-based biopharma with a couple dozen employees, Acadia Pharmaceuticals  (ACAD) - Get ACADIA Pharmaceuticals Inc. Report closed at $1.36 a share on Jan. 4, 2010.

Today, Acadia has a payroll of more than 430, its stock topped $50 early in December and finished 2019 near $45 a share, having increased more than 3,200% since the start of 2010.

Few other stocks have seen gains like this. Among them are Netflix  (NFLX) - Get Netflix, Inc. Report, and Domino’s Pizza  (DPZ) - Get Domino's Pizza, Inc. Report.

Acadia’s growth over the past decade has been driven by its development of Nuplazid, a successful drug to treat Parkinson’s disease psychosis.

Nuplazid is the brand name of an atypical anti-psychotic, pimavanserin, first synthesized by an Acadia chemist in 2001. (The company was founded in 1993 by Mark Brann, a professor at the University of Vermont, under the name Receptor Technologies.)

“Acadia's success is measured by the patients, families and caregivers we aim to serve with our therapies for debilitating central nervous system disorders," Elena Ridloff, Acadia's executive vice president and chief financial officer, told TheStreet.

"In 2016, the approval of Nuplazid (pimavanserin) transformed the treatment landscape for patients with Parkinson’s disease psychosis and, as we look forward, pimavanserin has the potential to be a multi-indication medicine, which is currently being evaluated in late-stage clinical trials to address the burden of dementia-related psychosis, negative symptoms of schizophrenia, and major depressive disorder,” Ridloff said.

The past decade has been a story of persistence and perseverance on part of Acadia, which successfully pushed pimavanserin through the lengthy, clinical trial process overseen by the U.S. Food and Drug Administration, a process that took more than six years.

Acadia began 2010 with a pivotal Phase 3 study of the use of pimavanserin in patients with Parkinson’s disease psychosis.

Acadia’s years of research began to pay off over a crucial two-year stretch in 2013 and 2014.

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In 2013, Acadia won a green light from the FDA for an expedited approval process for the use of pimavanserin to treat Parkinson’s disease psychosis.

A year later, the FDA announced “breakthrough therapy designation” for Acadia’s new drug based on pimavanserin, now named Nuplazid.

Buoyed by the positive regulatory developments, Acadia’s stock price soared, jumping from $4.78 at start of 2013 to $24.82 a year later, with the fast-growing biopharma added to the Nasdaq Biotechnology and Russell 2000 indices.

The FDA in 2016 gave a final go-ahead for the use of Nuplazid to treat hallucinations and delusions triggered by Parkinson’s disease psychosis, and, by early February, 2017, ACAD was trading at more than $34 a share.

Since then, Acadia has embarked on a major shift, working to win FDA approval to expand the use of pimavanserin to treat similar disorders.

In 2017, Acadia won “breakthrough therapy designation” for the use of the drug to treat psychosis in dementia patients.

After hitting $38.34 on Oct. 2, 2017, shares of Acadia gave back their gains over the remainder of 2017, falling over the next 10 months to a low of $13.03 on Aug. 13, 2018.

But over the past 16 months, Acadia has embarked on a spectacular rebound that has taken the biopharma’s stock price to new heights, rising from $14.33 a share to more than $50 a share.

The gains over 2018 and 2019 came as Acadia moved closer to winning approval to expand the use of pimavanserin beyond Parkinson’s disease psychosis, releasing the results of a Phase 3 Harmony study on the treatment of patients with dementia-related psychosis.

“The results … are an important advance for patients and caregivers who struggle with the burden of dementia-related psychosis where no FDA-approved treatment is currently available,” said Dr. Jeffrey Cummings, director emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, of the results of the Harmony study.

Acadia also published positive results of Phase 2 study and launched a Phase 3 trial on the use of pimavanserin as an “adjunctive treatment for major depressive order,” while also wrapping up enrollment for schizophrenia trials, Enhance and Advance.