Acadia Pharmaceuticals: A Bright Future Ahead!
06 December 2019
Acadia Pharmaceuticals' share price closed at +14% yesterday. The share price has more than doubled since the beginning of September, from 23.8$ to 50$ today. Acadia focuses on the development of treatments for several diseases of the central nervous system.
The company already has an approved treatment since 2016, Nuplazid, which treats psychoses related to Parkinson's disease. This compound is currently being studied in several conditions ranging from major depressive disorders to schizophrenia and dementia-related psychoses.
Yesterday, the company presented positive top-line data during “the Clinical Trials on Alzheimer’s Disease (CTAD) Meeting” studying Pimavansering (Nuplazid) in patients having dementia-related psychosis (Phase 3 HARMONY trial).
Last September, the company had already announced the early termination of this trial on supportive interim data, as Nuplazid had met its primary endpoint. Yesterday, during the CTAD medical conference, final data set of this study were presented:
Patients showed a 65% decrease in the relapse rate of dementia-related psychosis, with nearly 3 times lower risk of relapse compared to placebo patients. Besides, the drug also met the key secondary endpoint of reducing the risk of discontinuation for any reason by 2.2-fold.
- Nuplazid checked all boxes: symptoms reduction, psychosis stabilization, reduced risk of relapse, and a strong safety profile compared to the placebo.
- Acadia Pharmaceuticals plans to submit its New Drug Application (“NDA”) to the FDA in the first half of 2020. The drug benefits from a breakthrough designation, which means that the final decision will be made within 6 months versus the standard of 10 months after the NDA submission.
There is no approved-treatment available for the 2.4mn patients in the United States, about half of whom have been diagnosed and currently received antidepressants and older generation antipsychotics.
If Nuplazid is approved, the company will have a monopoly on this specific indication. Nuplazid has the potential to become the standard of care for patients with dementia-related psychosis. According to several analyses, Nuplazid's peak sales in this indication alone could reach between $1.8bn and $2bn.
We own Acadia Pharmaceuticals in our Biotechnology and Healthcare M&A certificates. We maintain our positions on the stock as we believe that the company could be an excellent candidate for a takeover. Indeed, in addition to this positive news on dementia-related psychosis, Nuplazid showed, a few weeks ago, solid data on the negative symptoms of schizophrenia. The same compound is also being studied in Phase 3 in major depressive disorder.
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