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ACADIA Files sNDA for Nuplazid in Dementia-Related Psychosis

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ACADIA Pharmaceuticals Inc. ACAD announced that it has submitted a supplemental new drug application (sNDA) to the FDA seeking approval for its marketed drug Nuplazid (pimavanserin) to treat hallucinations and delusions associated with dementia-related psychosis (DRP). If approved, this will be a potential second indication for Nuplazid.

Nuplazid is already marketed for addressing hallucinations and delusions associated with Parkinson’s disease psychosis. The drug is the first and the only FDA-approved treatment for the given indication.

The FDA had previously granted a Breakthrough Therapy designation to Nuplazid for the treatment of hallucinations and delusions associated with DRP.

The sNDA was based on data from the pivotal phase III HARMONY study wherein Nuplazid met its primary endpoint, having showed a statistically significant 2.8 fold reduction in the risk of relapse of psychosis compared to placebo. Moreover, the sNDA includes positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints.

Shares of ACADIA have increased 8.7% so far this year compared with its industry’s growth of 4.4%.

We note that ACADIA’s sole marketed drug Nuplazid witnessed strong sales since its launch. The drug recorded sales worth $90.1 million in the first quarter of 2020, reflecting an increase of 43% year over year. A potential label expansion will boost the drug’s sales in the future quarters.

Other than DRP, several additional studies on Nuplazid targeting different central nervous system (CNS) indications are currently underway.

Last month, ACADIA announced that it plans to combine the two-phase III studies of CLARITY-2 and CLARITY-3 on Nuplazid for the adjunctive treatment of major depressive disorder (MDD). Top-line data from the combined study is expected in the third quarter of 2020.

If positive, the results from the combined study along with the previously announced favorable outcomes from the pivotal CLARITY study will form the basis of an sNDA for Nuplazid as an adjunctive treatment of MDD.

Other studies on Nuplazid include the phase II ADVANCE study for addressing schizophrenia’s negative symptoms. The company plans to initiate a second pivotal study, ADVANCE-2, on Nuplazid in the second half of 2020 for treating negative symptoms of schizophrenia.

The company expects total net sales from the drug in the range of $420-$450 million for 2020.

Zacks Rank & Stocks to Consider

ACADIA currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Akcea Therapeutics, Inc. AKCA, Ligand Pharmaceuticals Incorporated LGND and NuCana PLC NCNA, all currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Akcea Therapeutics’ loss per share estimates have narrowed 33.8% for 2020 and 24.8% for 2021 over the past 60 days.

Ligand’s earnings estimates have been revised 7.2% upward for 2020 and 10% for 2021 over the past 60 days. The stock has gained 6.9% year to date.

NuCana’s loss per share estimates have narrowed 17% for 2020 and 18.1% for 2021 over the past 60 days.

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